FDA Expediting Accelerated Development of Novel Therapies for COVID-19 – Yahoo Finance

Financialnewsmedia.com News Commentary

PALM BEACH, Florida, April 28, 2020 /PRNewswire/ --The U.S. Federal government is working closely with companies and researchers to find treatments and vaccines to overcome the global health crisis. The FDA has been cutting red tape and has launched new programs that relax certain time consuming regulations while still assuring the efficacy and safety of the treatments. The FDA recently issued an update describing its most recent programs. The update stated that, as part of the administration's: " all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus. Active healthcare stocks in news today include: Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), Mesoblast Limited (NASDAQ: MESO), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Gilead Sciences, Inc. (NASDAQ: GILD), Aytu BioScience, Inc. (NASDAQ: AYTU).

"The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible," said HHS Secretary Alex Azar. "As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now. Each day, President Trump's all-of-America approach is making progress and providing new hope in our fight against the coronavirus."

There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA's accelerator program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly.

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR)BREAKING NEWS - Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 - Citius Pharmaceuticals ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, this week announcedthat it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS.

The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. NC-MSCs are mesenchymal stem cells derived from a single donor's fibroblasts that have been dedifferentiated into an induced pluripotent stem cell (iPSC) master cell bank, thereby avoiding the need to source additional donor cells. The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy. Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.

The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability, and efficacy of NC-MSCs in patients with moderate to severe ARDS due to COVID-19. The proposed trial, a Phase 1b/2 clinical trial, is titled "A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to SARS-CoV-2 Disease (COVID-19)," or "MARCO". The primary objectives of this study are to evaluate the safety and efficacy of NoveCite cells as a treatment for subjects with moderate-to-severe ARDS due to COVID-19 and to identify therapeutic doses.

Story continues

"MSCs have an established track-record of clinical safety, and have shown promise in the treatment of inflammatory lung disease," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus, Inc. "Our research has shown that the NoveCite cells, being derived from mRNA-reprogrammed iPSCs, secrete higher levels of immunomodulatory proteins than donor-derived MSCs, and have unique manufacturing advantages."

"We believe we have the key elements in place from a clinical design and manufacturing point of view to evaluate this novel cell therapy approach to deal with the current pandemic," said Myron Holubiak, Chief Executive Officer of Citius. "ARDS is a very serious complication for many patients suffering from COVID-19, and is believed to account for about 80% of the deaths in ventilated patients. There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management. Literature from previous investigational studies with MSCs in the treatment of lung injuries support the idea that MSCs could prove effective in treating COVID-19-related ARDS. We look forward to our FDA discussions and are excited to be at the cusp of what could be a novel and effective therapy for ARDS." Read this full release at: https://ir.citiuspharma.com/press-releases/detail/96/citius-announces-pre-ind-submission-to-fda-under-the

In other healthcare news of note:

Mesoblast Limited (NASDAQ: MESO) recently announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. At this time, seven have been discharged from the hospital. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City's Mt Sinai hospital.

In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced this week that first quarter 2020 financial results will be released after the market close on May 11, 2020. Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update, including the company's ongoing vaccine developments for COVID-19. A live and archived version of the audio presentation will be available online at http://ir.inovio.com/investors/events/default.aspx. This is a listen-only event but will include a live Q&A with analysts. Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10143530.

Gilead Sciences, Inc. (NASDAQ: GILD) Kite, a Gilead Company, and oNKo-innate recently announced the companies have entered into a three-year cancer immunotherapy research collaboration to support discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells.

Current cancer immunotherapy approaches primarily focus on T cell mediated anti-tumor immunity, including checkpoint inhibition and chimeric antigen receptor (CAR) T cell therapy. Like T cells, NK cells are a class of lymphocytes (white blood cells) that play a critical surveillance and effector role in the immune system. NK cells and T cells each have the potential to attack cancer cells, but have different mechanisms for tumor cell killing. Thus, appropriately activated and targeted NK cells may represent a differentiated approach that would be potentially complementary and synergistic with T cell mediated anti-tumor strategies.

Aytu BioScience, Inc. (NASDAQ: AYTU) recently announced that it has signed an agreement with Sterling Medical Devices ("Sterling") to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus.

The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.

DISCLAIMER: FN Media Group LLC (FNM), which owns and operates Financialnewsmedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNM is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNM expects to be compensated forty five hundred dollars for news coverage of the current press releases issued by Citius Pharmaceuticals, Inc. by a non affiliated third party. FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

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FDA Expediting Accelerated Development of Novel Therapies for COVID-19 - Yahoo Finance

GLOBAL TOOTH REGENERATION MARKET: INDUSTRY ANALYSIS AND FORECAST (2020-2027) – MR Invasion

Global Tooth Regeneration Marketwas valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 6.5% during a forecast period 2020-2027.

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Global Tooth Regeneration Market

Market Dynamics

The Research Report gives a comprehensive account of the drivers and restraints in the tooth regeneration.Somatic stem cells are composed and reprogrammed to induced pluripotent stem cells which can be placed in the dental lamina directly or placed in an absorbable biopolymer in the shape of the new tooth, which is a main source of the novel bioengineered teeth. Tooth replacement therapy is pondered to be a greatly attractive concept for the next generation bioengineered organ replacement. The global tooth regeneration market is mainly compelled by the high occurrence of dental problems with the new research and development activities. According to WHO, the Global Burden of Disease Study 2017 estimated that oral diseases affect close to 3.5 billion people worldwide, with caries of permanent teeth being the most common condition. Globally, it is likely that 2.3 billion people suffer from caries of permanent teeth and more than 530 million children suffer from caries of primary teeth. Additionally, positive refund policies for instance coverage of Medicaid insurance for dental loss treatment and emergence of new technologies like laser tooth generation techniques are projected to enhance the global tooth generation market throughout the estimated period.

Different researches are carried out by several academies and corporations to understand the possibility of stem cell-based regenerative medicines tooth regeneration. Though stem cell is the protuberant technology in research for tooth regeneration, several organizations are also leveraging laser, drug, and gel as mediums to regenerate teeth. For example, the Wyss Institute at Harvard University is engaged in research related to tooth regeneration using lasers. Tooth generation using stem cells is now under research through the globe. There are some key stem cells on which research are carried out such as stem cells from human exfoliated deciduous teeth (SHEDs), dental pulp stem cells, dental follicle progenitor cells (DFPCs), periodontal ligament stem cells (PDLSCs), and stem cells from apical papilla (SCAPs).A 2009 nationwide survey by the Nova South-eastern University in the U.S. publicized that around 96% of dentists expect stem cell regeneration to lead the future of the dentistry industry.However, occurrence rates are growing in low and middle-income countries. Though, some factors like the preference for endodontic treatment over tooth regeneration products in key dental surgeries and local inflammatory activity, which results in chronic complications to dental replacements, is anticipated to hamper the market throughout the forecast period.

Global Tooth Regeneration Market Segment analysis

Based on population demographics, the geriatric segment is expected to grow at a CAGR of XX% during the forecast period. According to NIH, the geriatric population has an average 18.9 remaining teeth. About 23% of the geriatric population has no teeth, making a positive market situation for manufacturing companies. The above 18 million dental procedures are anticipated to be carried out amongst the geriatric population between 2019 and 2027. Commercialization of tooth regeneration is expected to create lucrative market opportunities for industry players.Based on Type, the dentin segment accounted for a projecting share of the global tooth regeneration market in 2019, owing to the growing occurrence of dental surgery and the uprising demand for tooth regeneration in cosmetic surgery, particularly from developing economies like India, China, and Brazil.

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Global Tooth Regeneration Market Regional analysis

The Asia Pacific is projected to dominate the global tooth regeneration market throughout the forecast period. Tooth regeneration addressable market is likely to be highest in the Asia Pacific, with China and India located as the major growth engines. The occurrence of tooth regeneration is projected to capture this market. Also, the number of dental procedures is anticipated to grow at the highest CAGR of ~10.8% in the Asia Pacific between 2019 and 2027. Besides, the growing incidence of dental cavities & periodontics, particularly in emerging countries like China and India has led to the rising demand for orthopedic & dental surgery.North America and Europe are estimated to collectively account for the major share of global procedures during the forecast period.

Key Developments

In June 2018, Datum Dental Ltd., the prominent provider of OSSIX brand innovative solutions for bone and tissue regeneration for dentistry, announced clearances for OSSIX Bone with Health Canada and CE Mark approval in Europe. OSSIX Bone received FDA clearance in July 2017 and was launched commercially in the USA. In April 2018, Datum Dental, the leading provider of OSSIX brand innovative solutions for bone and tissue regeneration for dentistry, announced the expansion of its global distribution network. In the USA, Dentsply Sirona Implants is now promoting the full OSSIX line.

The objective of the report is to present a comprehensive analysis of the Global Tooth Regeneration Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market has been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analysed, which will give a clear futuristic view of the industry to the decision-makers.

The report also helps in understanding Global Tooth Regeneration Market dynamics, structure by analysing the market segments and projects the Global Tooth Regeneration Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Tooth Regeneration Market make the report investors guide.Scope of the Global Tooth Regeneration Market

Global Tooth Regeneration Market, By Type

Dentin Dental Pulp Tooth EnamelGlobal Tooth Regeneration Market, By Applications

Hospitals Dental Clinics OthersGlobal Tooth Regeneration Market, By Population Demographics

Geriatric Middle-aged Adults OthersGlobal Tooth Regeneration Market, By Regions

North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Tooth Regeneration Market

Unilever Straumann Dentsply Sirona 3M Zimmer Biomet Ocata Therapeutics Integra LifeSciences Datum Dental CryoLife BioMimetic Therapeutic Cook Medical

MAJOR TOC OF THE REPORT

Chapter One: Tooth Regeneration Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Tooth Regeneration Market Competition, by Players

Chapter Four: Global Tooth Regeneration Market Size by Regions

Chapter Five: North America Tooth Regeneration Revenue by Countries

Chapter Six: Europe Tooth Regeneration Revenue by Countries

Chapter Seven: Asia-Pacific Tooth Regeneration Revenue by Countries

Chapter Eight: South America Tooth Regeneration Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Tooth Regeneration by Countries

Chapter Ten: Global Tooth Regeneration Market Segment by Type

Chapter Eleven: Global Tooth Regeneration Market Segment by Application

Chapter Twelve: Global Tooth Regeneration Market Size Forecast (2019-2026)

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GLOBAL TOOTH REGENERATION MARKET: INDUSTRY ANALYSIS AND FORECAST (2020-2027) - MR Invasion

Human Embryonic Stem Cells (HESC) Market Overview, Top Companies, Region, Application and Global Forecast by 2026 – Latest Herald

Vitrolife

Global Human Embryonic Stem Cells (HESC) Market Segmentation

This market was divided into types, applications and regions. The growth of each segment provides an accurate calculation and forecast of sales by type and application in terms of volume and value for the period between 2020 and 2026. This analysis can help you develop your business by targeting niche markets. Market share data are available at global and regional levels. The regions covered by the report are North America, Europe, the Asia-Pacific region, the Middle East, and Africa and Latin America. Research analysts understand the competitive forces and provide competitive analysis for each competitor separately.

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Human Embryonic Stem Cells (HESC) Market Region Coverage (Regional Production, Demand & Forecast by Countries etc.):

North America (U.S., Canada, Mexico)

Europe (Germany, U.K., France, Italy, Russia, Spain etc.)

Asia-Pacific (China, India, Japan, Southeast Asia etc.)

South America (Brazil, Argentina etc.)

Middle East & Africa (Saudi Arabia, South Africa etc.)

Some Notable Report Offerings:

-> We will give you an assessment of the extent to which the market acquire commercial characteristics along with examples or instances of information that helps your assessment.

-> We will also support to identify standard/customary terms and conditions such as discounts, warranties, inspection, buyer financing, and acceptance for the Human Embryonic Stem Cells (HESC) industry.

-> We will further help you in finding any price ranges, pricing issues, and determination of price fluctuation of products in Human Embryonic Stem Cells (HESC) industry.

-> Furthermore, we will help you to identify any crucial trends to predict Human Embryonic Stem Cells (HESC) market growth rate up to 2026.

-> Lastly, the analyzed report will predict the general tendency for supply and demand in the Human Embryonic Stem Cells (HESC) market.

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Table of Contents:

Study Coverage: It includes study objectives, years considered for the research study, growth rate and Human Embryonic Stem Cells (HESC) market size of type and application segments, key manufacturers covered, product scope, and highlights of segmental analysis.

Executive Summary: In this section, the report focuses on analysis of macroscopic indicators, market issues, drivers, and trends, competitive landscape, CAGR of the global Human Embryonic Stem Cells (HESC) market, and global production. Under the global production chapter, the authors of the report have included market pricing and trends, global capacity, global production, and global revenue forecasts.

Human Embryonic Stem Cells (HESC) Market Size by Manufacturer: Here, the report concentrates on revenue and production shares of manufacturers for all the years of the forecast period. It also focuses on price by manufacturer and expansion plans and mergers and acquisitions of companies.

Production by Region: It shows how the revenue and production in the global market are distributed among different regions. Each regional market is extensively studied here on the basis of import and export, key players, revenue, and production.

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Tags: Human Embryonic Stem Cells (HESC) Market Size, Human Embryonic Stem Cells (HESC) Market Growth, Human Embryonic Stem Cells (HESC) Market Forecast, Human Embryonic Stem Cells (HESC) Market Analysis

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Human Embryonic Stem Cells (HESC) Market Overview, Top Companies, Region, Application and Global Forecast by 2026 - Latest Herald

Role of MyHC-embryonic protein in muscle development and disease – Tech Explorist

Dr. Sam J. Mathew, Assistant Professor at DBTs Regional Centre for Biotechnology (RCB), Faridabad, found out that loss of MyHC-embryonic protein leads to muscle abnormalities, including alterations in muscle fiber type, fiber number, and fiber size.

Secondly, the MyHC-embryonic protein is required to regulate the rate of differentiation of the muscle stem cells during development, and this effect is mediated by fibroblast growth factor (FGF) signaling. Although MyHC-embryonic is expressed in all muscles, they find that loss of MyHC-embryonic has differential effects on distinct muscles, and the adult mice lacking MyHC-embryonic displayed abnormal curved spine (scoliosis), an abnormality seen in individuals with Freeman-Sheldon Syndrome (FSS).

Targeted mouse models, they have characterized the function of MyHC-embryonic and developmental myosins in general, during embryonic stages of development. Loss of function of MyHC-embryonic leads to scoliosis in adult mice, a defect seen in FSS patients, and this mouse model could thus be a valuable tool in understanding the defects underlying this congenital disorder.

Myosins are proteins that are present in all cell types, meant for fundamental cellular functions such as cell movement, cell division, and transport of cargoes within cells. A specialized set of myosin proteins known as muscle myosins are expressed by the skeletal muscle, which are required for muscle contraction. While most muscle myosin proteins are expressed in the adult muscle, two are expressed only during embryonic development.

Very little is known about these developmentally expressed muscle myosins except that mutations in the gene encoding one of the myosins, MYH3, leads to Freeman-Sheldon Syndrome (FSS) in humans, a genetic disease causing severe musculoskeletal abnormalities including joint deformities, bent fingers, club feet, curved spine and facial anomalies. FSS patients have compromised movement, respiratory, speech and feeding problems, and delayed growth and development.

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Role of MyHC-embryonic protein in muscle development and disease - Tech Explorist

Cancer treatment made me infertile at 29heres how Im planning to have a family now – Well+Good

The ski trip to Utah wasnt supposed to be this way. It was just supposed to be a fun, extended weekend trip with my husband. We were planning to celebrate me getting my dream job six months after graduating from business school, his placement in a competitive cardiology fellowship program, and our new life in New York City. It certainly wasnt supposed to be the day I was diagnosed with Non-Hodgkins lymphoma.

I had started experiencing intense chest pain on the flight to Salt Lake City, so my husband and I went straight to the emergency room as soon as the plane landed.After six hours of various tests, the emergency room doctor did a CT scan to see if I had a blood clot from the flight, but instead, what he found was a 10-by-8 centimeter tumor between my lungs, right behind my heart.

This was not news I was prepared to hear. I was 29, and my husband and I had been talking about starting a family together. Suddenly, it felt like my whole future was in doubt.

Non-Hodgkins lymphoma is one of the most common cancers in the U.S., accounting for roughly 4 percent of all cancers. But that statistic is a bit deceiving. There are 30 types of Non-Hodgkins lymphoma, and I was diagnosed with a rare one, primary mediastinal b-cell, which afflicts about 3,000 young women a year. Its a type of cancer that starts in white blood cells, which are crucial for immune health. For me, treatment would involve aggressive chemotherapy and immunotherapy, which would take 18 weeks. In the process, my body would be put into menopause (because chemotherapy can damage the ovaries), meaning I would likely no longer be able to conceive naturally.

That was a problem, because my husband and I knew we wanted kids. We were readyI had even taken out my IUD six months earlier. I knew that one option I had would be to freeze my eggs before I began treatment; my friend Lindsay Beck, a cancer survivor, had started a charity called Fertile Hope that encouraged cancer patients to advocate for their own fertility preservation. It was her work I thought of as I sat in a cold doctors office back in New York City.

I understand that not every woman with cancer who wants kids may want to do IVF. Some may choose to become a mother in another way, such as adopting. Still others may not have the luxury of choice because they cant afford it or theyre already too sick to undergo fertility treatments. I was fortunate that I could. For me, I instinctively felt that IVF was the right choice for me.

Because the tumor was growing so rapidly, I only had enough time to complete a single egg retrieval and freezing cycle. I was fortunate that Memorial Sloan Kettering, where I had set up my oncology care, speedily connected me with a reproductive endocrinologist at Weill Cornell Medicine; without their fast action, I might not have had time for even that single cycle.

I was also fortunate that my insurance was covering the majority of the process (some states require insurance companies to cover egg freezing for people like me who are losing their fertility to cancer) and the remainder was being covered by a Livestrong scholarship. They are covering the freezing costs of my eggs for up to five years. Had I not been fortunate to have coverage in these ways, the process would have cost me $30,000.

Going through IVF was rough. I spent 10 days before the egg retrieval appointment giving myself multiple daily hormone injections to stimulate egg growthand the shots had to be timed perfectly. I also saw the doctor every day to make sure the egg follicles were growing properly. The last day, the doctor performed the egg retrieval, where they stuck a needle through my vaginal wall and suctioned the eggs out of the ovarian follicles to store and freeze. Fortunately, I was under sedation for that.

I was nervous about the whole process, but the evening before my retrieval day, there was actually an enormous fertile lunar moon. I saw it as a good omen and it most certainly was; I had 39 eggs retrieved that day, which is more than twice what my doctor was aiming for. Now that my eggs were safely frozen, I could focus on cancer treatment.

Two weeks after I finished freezing my eggs, I started cancer treatment. Physically, chemo and immunotherapy took an immense toll on my body. I had six rounds of treatment, each being three weeks long. During the first week of each round, I would receive the actual treatment in the hospital. A nurse would hook me up to a bag of chemotherapy drugs that would come home with me in a fanny pack. This treatment would run continuously for 36 hours, and then I would come back to the hospital for them to unhook me from it. The next week, my body would become neutropenic, which meant my white blood cells would dip and I would basically have no immune system, so Id have to be very careful about seeing anyone that even had the sniffles. The third week was spent recovering.

Often I was too tired to leave the couch. But my family and friends were amazing, coming over just to sit with me. Im so grateful for them, and my husband who was there for me every step of those long, 18 weeks.

It was draining emotionally, too. I started seeing a therapist. I had to get comfortable with the fact that I might die. In turn, that made me think about how I wanted to make my living days wonderful and joyous. I wanted to savor the days I did have. But of course its difficult to live life to the fullest when you have cancer; there are limitations to how you can genuinely enjoy yourself when youre constantly nauseous and exhausted. Mostly I just treasured the time I spent with my husband, family, and friends, just sitting and talking, being together.

I finished treatment in June 2018 and was considered to be cancer-free until a checkup in October 2018. My doctor did a CT scan, which showed an ominous mass in my chest. In order to make sure the mass wasnt cancerous, they had to do a biopsy, but because the mass was so close to my heart, it meant an invasive surgery that could be life-threatening. The surgery was scheduled for a few weeks later. After the surgery, my doctor told me the news I was dreading: My cancer was back.

I started treatment all over again, this time a more aggressive form of chemotherapy, a different immunotherapy. After nine weeks of that intense portion of treatment, I completed 20 sessions of radiation and had an autologous stem cell transplant, which had me in quarantine for 100 days last spring. I also focused even more on my mental and emotional health, seeing my therapist more often and starting reiki, acupuncture, and meditation.

My therapist suggested my husband and I adopt a dog, so we did, a mini labradoodle named Chloe. Shes become our little baby, someone the two of us can take care of together as a couple. Its a change from him taking care of me or me taking care of him; Chloe we take of together. She also just brings us so much joy and that alone has been incredibly healing.

On January 22, 2019, I officially went into remissionjust over a year after my initial diagnosis. When we got the news, I literally leaped out of my chair and hugged my oncologist. It was surreal. After spending the past two years coping with the idea of dying, now I could focus on the idea of living.

Before my cancer diagnosis, my husband and I were ready to start a family, and we still have that dream. Our doctors advise waiting 24 months after being in remission, so we have about 18 more months left before we have the all clear. Im 32 years old now and a lot of my friends have started having babies. Its hard that I could be experiencing my own childs first steps or birthdays right now, but thats been put on hold.

My husband is a cardiologist and is working on the front lines fighting COVID-19, so we cant be together physically right now. Im isolating apart from him, with Chloe. But when the time is right, we know my frozen eggs are there waiting for us. There is so much life out there for me, for us. And Im really excited to live it, with my family.

As told to Emily Laurence.

Originally posted here:
Cancer treatment made me infertile at 29heres how Im planning to have a family now - Well+Good

Incarceration Is Killing Us – Truthout

A woman plays a horn while taking part in a vigil outside Queensboro Correctional Facility on April 23, 2020, in New York City.Johannes Eisele / AFP via Getty Images

Kelly Hayes talks with Alan Mills about COVID-19, prisons and making bold demands.

Note: This a rush transcript and has been lightly edited for clarity. Copy may not be in its final form.

Kelly Hayes: Welcome to Movement Memos, a Truthout podcast about things you should know if you want to change the world. Im your host Kelly Hayes.

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Tensions are high in the U.S. as lockdowns continue in some states, while others have begun to ease restrictions. Gun-toting right-wing protesters have staged astroturf protests, demanding the economy be reopened. Doctors and scientists have continued to argue in favor of strict lockdowns to stem the spread of the disease. And stuck in the middle, we have everyday workers who either cannot escape the threat of going to work, or who are becoming increasingly desperate for any means of income in the absence of government relief.

What I hope people are considering as we debate our demands for stimulus and whether or not we reopen the economy, is that we are fighting for the dynamics that will define our experience of a plague. We are not talking about a policy fight that begins and ends in the next few months. We are talking about our experience of a slow-motion catastrophe of unknown duration. We dont know if this disease will slow down in the summer. It is presently thriving in some very warm and sunny environments. But if we do manage to slow things down, we are still looking at another wave of this in the winter or fall that could be much worse.

We are fighting, right now, for what our society looks like in its darkest hours. Economies can be manipulated. Their rules can be bent, broken and redefined. Thats not true of the coronavirus. There is no question which of these problems we should be leaning into. Rather than sacrificing ourselves to the virus to save the economy, we have to transform the economy as needed to survive the virus.

We have to be willing to change everything, and part of that will be changing how we assess the value of peoples lives. Right now, many of us are being viewed as disposable by people who have significantly more power and money than we do. Even within the working class, there are gradations in how we experience crisis, and how much we benefit from the subjugation and disposal of others. Imprisoned people are generally among those at the bottom of such hierarchies. We are conditioned by society to look away from the horrors of the prison system and to blame those experiencing carceral violence for the abuse they suffer. We are conditioned to believe that some people are expendable. Because capitalism doesnt simply happen to us. It infects our lives and our relationships with others. It positions us within dynamics that lead us to enact its violence, just as we do when we ignore the experiences of imprisoned people.

To transform our society such that we are not disposable, we have to destroy the moral framework that absolves the system of its violence. And we have to destroy the framework that absolves us of ours. Because its the same framework. It always has been. Its a framework that tells us its okay to let people die, and that tells others that its okay to let us die. This terrible moment is providing us with many opportunities to redefine who we are to each other. The catastrophe that is playing out in U.S. prisons is one of those opportunities. We have a moral choice about whether to allow these people to be sacrificed to the virus, or whether we will insist that they are not disposable and must be saved. If we cannot internalize this lesson ourselves, then we arent going to have what it takes to imagine a better world, let alone build one.

So lets talk about COVID-19 in prisons and how we can get people free.

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Kelly Hayes: Across the United States, people are locked down in their homes to keep COVID-19 at bay. Meanwhile, millions of imprisoned people are trapped in facilities where the contagion is running rampant, creating internationally recognized epicenters of contagion. And while some Americans may not be concerned with the fate of prisoners in this moment of crisis, that view couldnt be more short-sighted, or self destructive.

Todays guest is Alan Mills, the Executive Director of the Uptown Peoples Law Center in Chicago. Alan has been fighting for the rights of imprisoned people for decades and has played a key role in recent efforts to free prisoners who are locked in facilities where the coronavirus is spreading like wildfire. Alan, welcome to the show.

Alan Mills: Thank you. Well, the podcast now I get a chance to be on it.

KH: How are you doing today, friend?

AM: You know, its a little lonely not having coworkers. And I hate the fact that I cant walk along the lake all by myself. But you know, all things considered, Im doing good.

KH: Glad to hear it and so glad to have you on the show today. During this crisis, the Uptown Peoples Law Center in Chicago has played a prominent role in the fight to liberate Illinois prisoners who are trapped in dungeon-like conditions, and in some cases, surrounded by death. But before we get into legal maneuvers, I just want to clarify something for some of our listeners who may feel like they dont have the head space to think about what happens to prisoners right now. Can you explain why that mindset is misguided?AM: Well, first and most, I think in some ways, most fundamentally, people in prisons are not like some separate species. You know, the Uptown Peoples Law Center started doing prisoners work when we were founded, not because we were particularly interested in prisons, but because it was people from Uptown who went to prison and people from prison came back to the community. And the people who founded this organization thought that it was silly to think of somehow when they went behind a prison wall, that they became not part of their community. And I think thats true all over the country. Most people in [state] prisons, 95% get out. A lot of people on the outside end up going in. So to think that theres an impenetrable wall between prisons and people in the community is just wrong. People have to remember that what happens in prison doesnt stay in prison. If we really want to get rid of this pandemic, which is spreading throughout the world, were going to have to solve the problem in prisons. You know, just because of the end of their sentence, 300 people a week are released from Illinois prisons. Those people are coming back to our communities. The question is, are we going to safeguard them so that when they come home, theyre healthy, or are they going to come home with an extraordinarily infectious disease? Allowing them to call them with a disease does absolutely nobody any good.KH: Were also talking, in some cases, about prisons that are located in counties that dont have much in the way of medical infrastructure.

AM: Absolutely. I mean, weve already seen Stateville Correctional Center, which is the Illinois prison which has the most tested and confirmed COVID-19 cases as overwhelmed Joliets ICU beds, and for a while its emergency rooms. But Stateville is located in one of the larger communities among our prisons. I look at Menard Correctional Center, which is way down in Southern Illinois, in Randolph County. Randolph County has one of the highest concentrations of COVID-19 in the state outside of the immediate Cook County area, and there are 2000 prisoners there. In the entire County, there are two ICU beds. In the entire southern 18 counties in Illinois, theres less than 100 ICU beds, and thats where the plurality of our prisoners are. So if a lot of people in prison get sick, its not only going to be a prison problem, its going to spill out into the community and will crash our public healthcare system throughout at least the southern half of the state.

KH: Whenever theres a well publicized tragedy in U.S. prisons, conditions in these facilities are often described by journalists as though theyre exceptional. In many ways, its a tendency that mirrors our current public dialogue about the financial crisis. To some people, the idea of millions of Americans experiencing a simultaneous economic freefall was unthinkable. But for others, this meltdown is consistent with our long held fears about where this system was headed. Can you say a bit about how the nature of U.S. prisons makes moments like this one inevitable?

AM: Yeah. I mean, we have built this problem over the last 50 years, starting really in the early 1970s, we began the trend towards mass incarceration where we incarcerated millions and millions of people. We currently have over 2 million people locked in our prisons and jails throughout the country, and that is unprecedented worldwide, and certainly in the history of this country. We now have about seven times as many people in prison as we had in the early 1970s. So packing people into small spaces is in and of itself a recipe for disaster and has been for years. This is not the first outbreak thats happened in prison. Weve seen that certainly with tuberculosis. Weve seen that with the regular old flu that comes around. So nothing here is new, but I would go beyond that. We have also, under-invested perhaps isnt the right word, but we certainly havent taken care of the people that we put behind prison walls. Illinois is a particularly good example of that, where the medical care in this state has been horrific for decades.

About five years ago, Illinois spending per prisoner was towards the very bottom of the United States. We were down at about 47 in terms of the ratio between staff and prisoners, medical staff and prisoners, we were 49th of 50. Weve improved a little bit. So maybe now were in the higher forties, but were still way down at the bottom of the stack. We at the Uptown Peoples Law Center sued about the medical care that was provided in prisons a decade ago, long before anybody thought about COVID-19 or the coronavirus, or any of these other things. We just werent treating really, really basic stuff. I can remember vividly a prisoner that I had been corresponding for awhile with, and hed been complaining about the lack of medical care, down at Tamms Correctional Center, our supermax prison, now thankfully closed.

And he said, When I was up at Stateville, I got a prostate test and they told me my PSA levels were elevated. They said it wasnt bad, but that I should have it checked every year to make sure it didnt get worse. Before any kind of follow up, he got transferred into Tamms and the doctors at Tamms claimed he was lying, so he never had an elevated test.

They checked his records, it wasnt there, and [they claimed] he was just trying to maneuver the system and try to get something he wasnt entitled to try and get away out of his cell. He got worse and worse, and they kept telling him, why youre getting older, you have arthritis, you know, thats why your have all these aches and pains. And he was like 40 years old. Finally, I went down to visit him and he literally had to crawl into the visiting room. He could not stand up. He could not get in and out of bed. He could barely use the toilet. And I just raised holy hell when I was down there. They finally took him to an outside doctor who realized who actually checked and found the old levels and did his tests, and discovered that he not only had cancer, but that at that point it had metastasized. They then immediately put him on to chemotherapy. However, a month later he died. This is a tragedy that repeats itself over and over again, even when there isnt a crisis.

Now, we settled this case about medical care almost a year ago and the settlement gave the department really a 10 year period. It was going to take 10 years to bring them up to minimal constitutional standards where theyre actually providing medical care that people desperately needed. They were that far behind. Unfortunately, nature has not given us 10 years. Here we are less than a year later and we have a pandemic, not just on the outside, but spreading through the prison system. And we are simply totally unequipped to deal with that. You know, I think in some sense, the most dramatic example of that is the fact that its Stateville and they had to bring in the National Guard in order, not for security purposes, but to provide doctors. So we had to bring in essentially army doctors because the Stateville medical system was so overwhelmed, they just could not deal with such simple things as checking peoples temperature, checking peoples blood oxygen levels, and they just couldnt do that sort of really simple stuff, let alone actually isolating people, let alone testing everybody. What that has meant is we have 10 deaths of prisoners at Stateville and we still dont have universal testing of all the prisoners in Stateville.

KH: We have a habit in the U.S. of congratulating ourselves for abolishing things that still exist, albeit less officially. The state of Illinois officially did with away with the death penalty in 2011, but as youve just outlined, death by incarceration has continued. Can you say a bit more about how death by incarceration is enacted, even in the absence of a pandemic?

AM: Yeah. We like to talk about not having a legal death penalty, but having this slow motion death penalty. And slow motion in the sense of like the cancer story I just told, this is somebody who did not have a death penalty, did not have a life sentence, but nonetheless died because of what happened in prison.

You and I have talked about Tiffany Rusher before. Tiffany was a young woman who went into prison. Im on a prostitution charge. She was doing survival sex work. And got into a fight, got put into solitary, and her mental health just bottomed out when she was in solitary, got really bad, became suicidal, started to engage in self harm, and rather than provide treatment or realize that solitary was a really bad idea, the department of corrections solution, and I put solution in big air quotes, which you cant see, was to put her into a crisis cell where she was stripped naked, taken away all of her possessions, no books, no magazines, no TV, no radio, given a suicide proof smock to wear and left alone.

She cycled in and out of these crisis cells for months, would spend a couple of days, sometimes strapped down to a bed, and then as soon as she was released, she would attempt to harm herself again. Eventually, for the last eight months of her sentence, she sat in one of these crisis cells for eight straight months with nothing whatsoever to do.

No human being to speak to. Unsurprisingly that did not make her better. And eventually, she committed suicide and was successful at doing so. So, you know, thats another example of somebody who got the slow motion death penalty, thereby solitary plus bad mental health care.

We have another client who hasnt died, thank goodness, but did lose his leg. What started off as a blister went untreated and improperly treated for years, and eventually ended up with gangrene spreading up his leg, which had to be amputated. So these are all things that happened even before any kind of crisis happened. That was just the base level of care we were failing to provide to people who had what on the outside are relatively routine conditions, things that are treated every day. But inside, even those routine conditions, if left untreated long enough, can end up killing people.

And thats what we mean by a slow motion death penalty that Illinois, and other states, I dont want to say Illinois is unique, cause its not, but Illinois is among the worst. And we simply kill too many people.

KH: So what has the legal fight to free imprisoned people due to COVID-19 looked like?

AM: Well, its sort of proceeded on two fronts. The part that Ive been most involved in is saying that really theres nothing you can do in a prison that will keep people safe. Simple things like what we now all know about social isolation, which is why the tools are not sitting in the same room having this conversation. Were doing it remotely. Social isolation in a prison cell is impossible. Youre talking about two strangers who inhabit a cell that may be as big as 6 x 12, or maybe as small as four and a half by 10 feet. What four and a half by 10 feet means is it smaller than the typical parking place. It means that if you stand up and hold out your arms, you cant touch both sides of the cell with your fingertips because its not that wide. You can touch one side with your elbow and the other side of the fingertips. It means that both people can stand up in this all at the same time, but they cant both move at the same time in that cell.

So the idea that in those kinds of conditions you can somehow maintain a six foot separation is absurd. Other people live in open dormitories. We may have 40 people living and sleeping within a foot of each other. Again, its absolutely impossible to keep six foot apart. But even people who have their own cell, who are alone, have to come in contact with staff over and over and over again. And staff, frankly, has been, from all we can tell, the vector that has brought the coronavirus into the prisons. If you think about a persons typical day, if theyre in their cell, they get fed, which means that a staff person is walking down the gallery, touching bars, touching trays, picking them up, handing them out. And each of those contacts is a pathway for cross contamination. Or if the guard himself got it from the outside and brings it in, he could be handing that off to a hundred prisoners in a day. If you think about movement, anytime you leave your cell, you have to be handcuffed. Its impossible for a guard to handcuff somebody maintaining a six foot distance. They have to be right up in your face. They have to be patting you down, touching your clothes, touching your, you know, your hands, your legs, all of your clothing. Thats what a pat down is. When we move people, we tend to put them into a group cages. So for example, weve heard lots and lots of stories where people cells get searched and during that search, what they do is they move people out of their cells, put four or five of them together in a bullpen while their cells are being searched.

Again, theres no way with six guys or five guys in a small cage that you can maintain any sort of separation, and thats when coronavirus spreads. We had a tragic case at Stateville where somebody had been separated because they were positive for coronavirus, and then apparently he got into some oral dispute with the nurse about how they werent really taking his temperature properly or, I dont know the details there, but at any rate, somebody decided that he had violated some internal rule, so they decided to send him to solitary, walked him over to solitary where they did not have positive people. Within a week, everybody on that same unit tested positive. So the very idea that somehow we can isolate people in prison cells and keep them safe, we think is just wrong. So weve been pushing the governor to use all the tools that are available to him to get people out of prison, the only way to stay safe in prison is to leave. So weve been asking, the governor has in fact, commuted sentences of a dozen or more people.

The state has the right to get back six months of good time to most prisoners in the system, and theyve been doing some of that to get people out a little bit early. But they also have the right to put people on home confinement. Anybody within the last six months or a year of their sentence or anybody serving a lower level felony, thats not a sex offense, can be put on home confinement. They havent done a lot of that. They also now have the right to furlough anybody for medical reasons, protecting them from the COVID virus is obviously a medical reason. So literally anybody they want to, they could at this point send home or put on an electronic bracelet to get them out of a prison cell. Theyve done very little of that. Although the governor did loosen the requirements for medical furlough. So literally anybody whos now eligible, but theyre just not using that tool. So weve gone to court and in a couple of different ways to try to get the court to order a speed of up of that process. Sadly that has not worked. It has worked in other states. Ohios federal court just issued a great order getting some of the elderly and more vulnerable people out of one of the prisons in Ohio. A couple of jails around the country have had some release orders and a couple of the immigration detention centers are beginning to release people in order to keep them safe. Illinois has not yet. The other set of litigation, which we at the Uptown Peoples Law Center are also involved in, is trying to improve the care of those people that are left. So weve been trying there. There is a federal monitor in our class action lawsuit thats been going on for a decade and hes been trying to get them to impose better isolation procedures. For a while we had a big fight over whether theyre actually gonna provide soap to people, since the first and biggest advice everybody gets is you should wash your hands regularly. You cant do that if you dont have soap and running water. At least that problem seems to be solved in most of the prisons [in Illinois]. There was not enough soap, and theres not enough bleach and other cleaning supplies, but at least everybody has some soap now. The very fact you have to fight to get people soap is just absurd. So, you know, those are all the kinds of legal approaches we get. But I really have to say, although Im a lawyer and I think the legal system has its uses , what this has really proved to me is there are real limitations on what the legal system is going to do for prisoners in an emergency. The law is much better at cleaning up messes afterwards than preventing them from happening in the first place.

KH: Illinois governor J.B. Pritzker has faced some backlash for releasing prisoners that some critics have characterized as violent. Can you speak to that criticism?

AM: Uh, its wrong. IDOC, if anything, and the governors office have been overly cautious in who they let out of prison. Nobody that they have let out is at high risk of committing any sort of new crime, let alone any, any sort of violence. Which is not to say nobodys ever going to commit a crime that is released. People forget that in the ordinary course, Illinois and most states have a recidivism rate of about 50% or more. So even under normal circumstances, 50% of the people who would get out of prison are going to commit another crime. So does this to require that any sort of reform be 100% successful and have zero recidivism rate is just absurd. Thats not the way this society is set up. We wouldnt have 2 million people in prison if it was easy to stay out. But if anything, hes being far too cautious. And what has happened is that the people who are making these criticisms have really just focused on the name of the crime that somebody committed. Its easy to say, well, this person committed murder, or this person had a life sentence. But you have to look behind that and say, what really happened? So for example, one of the murder cases I know about was a 14 year old who was involved in a gun sale with a much older person. His job in that sale was to hang onto the gun.

The sale went bad and there was a struggle over the gun. It went off by accident and he was convicted of murder. Everybody admitted that the gun went off by accident, but it was in the course of committing a felony and therefore under Illinois is very strict felony murder statute, hes just as guilty of murder as is somebody who went out and stalked somebody and shot them. So, you know, and, and hes now spent 13 years in prison, is a very different person, has taken advantage of every opportunity he had in prison. And the governor commuted his sentence, something that had been on his desk for a year, having nothing to do with COVID-19 or the current pandemic. This is somebody who should not have spent any time in prison and certainly should not have spent 13 years in prison. It was certainly time for him to go home. So you know, there are lots of those stories. You cant just name a crime and then say, well, this person is violent and therefore theyre, theyre too dangerous to let out. You need to know the details of what happened. Who was that person then? How did they get involved, and what have they done since, and who are they today? Identifying people by the name of their crime is just shortsighted, wrong, and dehumanizes people in prison.

KH: I couldnt agree more. And this also highlights the problem with some of the well-intentioned language being invoked by advocates of mass release. Some people who have pushed for decarceration have used language like nonviolent offenders to elicit sympathy for prisoners who are perceived as non-threatening. Can you say a bit about the violent/nonviolent divide and why relying on these distinctions is dangerous?

AM: Yeah. I mean, first of all, theyre just wrong. Statistically. You know, the highest recidivism rate is among people who are convicted of drug crimes. Everybodys favorite example of nonviolent, which is not because theyre bad people, but because we dont treat the underlying condition in prison. So unsurprisingly, people who are addicted to drugs who spend six months in prison and go home, arent magically changed. Their lives arent changed and their addiction wasnt changed. But more fundamentally, what someone did, often decades ago, doesnt define who they are. It didnt define who they were back then, and it certainly doesnt define who they are today. So to make this distinction between violent and nonviolent, simply as labeling people by one act, they did one day in their life, that is not how any of us would like to be judged, by the worst day in our life, which is what generally people in prison are there for, is something that happened on the worst day of their. Wed all like to be judged on the way weve lived our lives in general, whether weve done, you know, good things or bad things, and. Just to make this distinction, which is arbitrary in the first place, between violent and nonviolent makes no sense at all. I dont think its okay to sentence anybody to death and its certainly not okay to sentence people to death by medical neglect, which is what were doing.

KH: Absolutely, and I definitely want our listeners to be especially mindful of language when advocating or the freedom of imprisoned people. I know that, in my own organizing, when we worked on a set of local and national grassroots demands related to COVID-19, there were people from all over the country who consulted on that list, including scientists, healthcare workers and, obviously, grassroots organizers. So it was no simple matter to devise language that everyone would be comfortable with, and we knew we were going to fall short, and even acknowledged those limitations in the document. But looking back at the demand around prisons and COVID-19, I wish we had only talked about mass release. We did talk about mass release, but we also talked about what care should look like inside prisons. And while we know that not everyone will be released, and we do want higher standards of care for people trapped inside, we know that, organizing within this system, if we ask for a mile, were lucky if we get an inch. We know that theyre not going to let everyone go, but I also feel strongly that what we should be aiming for is life and freedom for as many people as possible, and not trying to negotiate for lesser outcomes. Theres also a difference between whats leveraged in court and how we appeal to people narratively, and how we convey the values behind our demands. And I just hope thats something that people who do the kind of work Im involved in are critical of, in terms of assessing the ways we can improve our demands, improve our language and improve upon the vision we are presenting to the public. Because I think we have to ask ourselves if the story we are telling is about the value of human life and what justice looks like.

AM: Yeah, I couldnt agree more. I think the idea that somehow, we can keep people safe from this pandemic and a prison environment if we only like tweak the way we treat them, if we only hire a few more doctors or do a different rule, is just fooling ourselves. Prisons are petri dishes for disease and particularly for extraordinarily communicable disease like this one. And as I said before, its not going to stay behind prison walls. If we want to get rid of this virus and society as a whole, we have no choice but to get rid of it in prison. And the only way to get rid of in prison is to dramatically reduce the number of people that are in prison. And youre not just talking about the easy cases, the old people, the people that never should have been in prison in the first place, or should have been released decades ago. You gotta really look at whos in prison and is there any justification for keeping them there, and the answer in most cases is going to be no.

KH: I dont think that most people in the U.S. realize that, in the late 60s, there were actually discussions about whether or not prisons had outlived their usefulness and should be abolished altogether. Of course, all of that changed as a shifting economy and the destruction of the welfare state created a broadening criminal dragnet. These mechanisms have facilitated the violence of capitalism by separating so-called productive members of society from people who are deemed surplus. Some of the people who were incarcerated during the early prison boom of the 70s and 80s are now elders who are trapped in the path of COVID-19. In a sense, millions of tragedies have delivered us to this moment, which could serve as a breaking point for an untenable system. Can you tell us what has historically happened when conflicts over prison conditions come to a head, and what you hope will happen instead?

AM: I think its important and people really dont realize who is in our prisons these days. Back not that long ago, the typical prisoner is what a lot of people think of: a 20 to 25 year old, usually a man who has committed a violent act and is being punished for that. Today in Illinois, for example, over 45% of our prisoners are over the age of 50. We have a couple of dozen who are over the age of 80. This is the result of decades of truth and sentencing, mandatory minimums and a bunch of other laws that have gradually increased the amount of time people spend in prison. So that what used to be a young persons facility has turned into a senior citizen home. So, you know, I think thats how it, in some sense, how we got here today. But your larger question really goes to how did we end up with so many people in prison at all? How did we end up with the situation where a large part of the public is willing to write off prisoners? And I think that there were some real turning points historically where that happened. And I like to point to Attica as being one of the crucial turning points here. In the early 1970s, conditions in Attica prison, which is in upstate New York, were horrific, but actually about the same as they are today in many of our maximum security prisons. Illinois has really old prisons. All of Illinois maximum security prisons were built before the 1920s. Attica was built at almost the exact same time as our Illinois prisons were and looks exactly the same. Prisoners there began to protest, first peacefully, and then when there was a crackdown, there was at first some pushing back, pushing and shoving sort of backwards, and ultimately they took over the entire prison. The narrative right then and there broke into two different storylines that were being put out. On the one hand, there was a storyline that Attica was such a mess, that was so repressive, that it was so overcrowded and prisoners had been denied so many things that all of us consider to be normal and almost a right, like toilet paper, like soap, like educational opportunities. All those things were denied to people in Attica. And there was a real movement saying, well, of course, if you dont fix the prison system, this is going to happen over and over again.

But there was also a counter narrative that was very carefully designed, and because of the work of some really good historians, like Heather Ann Thompson who wrote an entire book about the Attica experience, Blood in the Water, we know that it was a very intentional that before the takeover happened, then governor [Nelson] Rockefeller met in his pool house with people from the department of corrections, from the local states attorneys, from the state police, and they all came up with a narrative and they all came up with this narrative that this was the radical Black people who were causing this problem, even though, in fact, everybody, whites, Latinos, and Blacks, all had a leadership role in the movement and were supported by outside organizations covering all of the ethnic groups. But the narrative that came out was very much that this was a Black person problem, and that these people were animals. And this was frankly coordinated all the way up to the White House. Because Nixon did us the favor of taping off his conversations, theres an audio tape of a conversation between Nixon and Rockefeller where Nixon says, well, this is the Blacks that are doing this, right? And Rockafeller says, yeah, its the Blacks. And Nixon says, well, you wont have a problem. And the next day, Rockefeller authorizes the armed takeover of the prison. And as a result of that, over a dozen people were killed. The original narrative that was put out was that the people being killed were the prisoners who were slaughtering the hostages they had taken. We now know that was completely false, that not a single hostage was harmed by any of the prisoners. Rather, the hostages were all killed as a result of the takeover by members of the national guard or, or sheriffs or anybody else got a gun there, as were the prisoners. So everybody died of bullet wounds. Nobody died of anything that the prisoners did. But thats not the narrative that went out. The narrative was, these are animals.

We had no choice but to take them back over again. They were slitting peoples throats. They even made up a story that theyd emasculated one of the, one of the guards using a knife. And all that was totally false. But nonetheless, that narrative that somehow prisoners are different from those of us that are on the outside, that somehow they are uncontrollable animals, that the only way to punish them is to deprive them of everything.

That narrative won out. And that was a very intentional, you know, this was before Fox news, but if Fox news had been around, they would have been leading it. But it was a very intentional narrative by the powers that be saying, we want to expand the system. We want to use this system as a way of not only cutting out, as you said, excess labor, um, people arent really needed, but also radicals. Also people who are calling for change, people who are organizing, and we saw this in the Black Panther Party where they ended up incarcerating or killing the leadership, labeling them as criminals in order to do so. So this has been an intentional movement to convince the public at large that its okay to lock up more people than have ever been locked up in the history of this country or in the history of this world. That its okay to spend millions and millions and millions of dollars doing that even though the crime rate has not in fact changed at all. All thats happened is weve destroyed communities.

KH: In addition to how we see imprisoned people as being fundamentally dangerous or harmful, theres also the matter of how we see ourselves, and how structures like the prison system bolster ideas that people have about themselves as being fundamentally good or decent. A lot of people cling to the idea that they are good people, positioning goodness as an identity, rather than something we create outside of ourselves with effort. But some of those people, who see themselves as fundamentally different than prisoners, and sort of inherently law-abiding, may be in for a rude awakening in our changing world. As capitalism cuts its losses in this time of crisis, what do you think the broadening dragnet of criminalization will look like?

AM: So on the one hand, we are certainly criminalizing dissent more than we have done in many, many years in this country. But on the other hand, we are also driving more and more people to economic desperation. Which on one hand leads to things like self-medication through the use of drugs, which we then make illegal and use that as a reason to incarcerate people, and also makes some people engage in activities that are illegal but are actually crimes of survival, which may be things like buying or selling marijuana, which is now legal, but only if you do it from a licensed facility. If you buy from an unlicensed person, its still a crime and you can still go to jail for it. If you possess it and you cant prove you bought it from a licensed facility, you can still go to jail for it. If you are hungry and you shoplift a bag up a loaf of bread, you can still go to jail for it. So we not only criminalize dissent, we also criminalize survival. And were seeing right now the number of people who are losing their jobs or who are temporarily without any sources of support, is skyrocketing. I believe the statistics are that on April 1st about a quarter of the population could not pay its rent in full. May 1st I suspect that number is going to go up rather dramatically. You know whats going to happen when we have 50,000 people in Chicago all being evicted at the same time? Whats going to happen when our homeless population swells and all these folks have no way of eating or living other than staying on the street? Were going to criminalize that. That is the history of this country. We end up criminalizing people after we deprived them of the ability to take care of themselves.

KH: So with all of that said, what gives you hope?

AM: What gives me hope actually is the grassroots. We are seeing more people out on the streets, even though we cant do mass demonstrations, we are seeing people be very creative in ways that they can push back against this. And Im not talking about lawyers, Im talking about regular old people who are, you know, loved ones who are not involved in this movement at all before picking up the phone, calling legislators, organizing Zoom chats, flooding the governors press thing that he does every afternoon that the comments and chats there was demands that people be out doing car caravans, doing car protests in the loop.

Where people can still stay apart. Doing a prayer vigil outside of Cook County Jail where everybody was six feet apart doing the prayer vigil. So it really gives me hope that there are people out there who are actively attempting to bring this to the publics attention and its working. I think prisons have gotten more press in the last six weeks, then they got for the six months prior. So everything thats happening, both legal and grassroots, have done a really good job of grabbing the attention of the public. My hope is, and the reason I have some hope, is that that conversation will not end once people have the right to go back out of their houses, that this is forcing societies as a whole to reexamine a whole lot of things.

But in particular, the question of who do we have locked up, why are they there, and do we really need in this country 2 million people to be locked in cages? I think the answer is clearly no and more and more people I think are coming to that realization as they see whats happening in prisons, and are hearing from their neighbors that in fact this is regular old people who are locked in prison, not some animals from outer space.KH: Well, if any of our listeners are riled up and eager to get involved, you can support the work the Uptown Peoples Law Center is doing by visiting their website at uplcchicago.org, and if you would like to learn more about efforts to support imprisoned people via mutual aid you can go to the website Beyond Prisons, and thats at beyond-prisons.com. And Alan, I want to thank you from the bottom of my heart for joining us today, and for all that you do.

AM: Thank you, Kelly, and thank you for doing such a great podcast every week.

KH: I also want to thank our listeners for joining us today, and remember, our best defense against cynicism is to do good, and to remember that the good we do matters. Until next time, Ill see you in the streets.

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Incarceration Is Killing Us - Truthout

Stem Cell Therapy Shows 83% Survival in COVID-19 Patients Dependent on Ventilator – HospiMedica

Ventilator-dependent COVID-19 patients with moderate/severe acute respiratory distress syndrome (ARDS) who were treated with intravenous infusions of an allogeneic mesenchymal stem cell product candidate had a survival rate of 83%.

The allogeneic mesenchymal stem cell product candidate remestemcel-L from Mesoblast Limited (Melbourne, Australia) was administered within the first five days under emergency compassionate use at New York Citys Mt Sinai hospital during the period March-April 2020. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at Mt Sinai hospital. 75% of the patents successfully came off ventilator support within a median of 10 days, in contrast to only 9% of ventilator-dependent COVID-19 patients being able to come off ventilators with standard of care treatment and only 12% survival in ventilator-dependent COVID-19 patients at two major referral hospital networks in New York during the same time period. These poor outcomes are consistent with earlier published data from China where mortality rates of over 80% were reported in patients with COVID-19 and moderate/severe ARDS.

The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS, said Mesoblast Chief Executive Dr. Silviu Itescu. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.

There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators, said Mesoblast Chief Medical Officer Dr Fred Grossman. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS.

Related Links:Mesoblast Limited

Excerpt from:
Stem Cell Therapy Shows 83% Survival in COVID-19 Patients Dependent on Ventilator - HospiMedica

Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory…

CRANFORD, N.J., April 27, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc.. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS.

The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. NC-MSCs are mesenchymal stem cells derived from a single donor's fibroblasts that have been dedifferentiated into an induced pluripotent stem cell (iPSC) master cell bank, thereby avoiding the need to source additional donor cells. The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy. Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.

The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability, and efficacy of NC-MSCs in patients with moderate to severe ARDS due to COVID-19. The proposed trial, a Phase 1b/2 clinical trial, is titled "A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to SARS-CoV-2 Disease (COVID-19)," or "MARCO". The primary objectives of this study are to evaluate the safety and efficacy of NoveCite cells as a treatment for subjects with moderate-to-severe ARDS due to COVID-19 and to identify therapeutic doses.

"MSCs have an established track-record of clinical safety, and have shown promise in the treatment of inflammatory lung disease," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus, Inc. "Our research has shown that the NoveCite cells, being derived from mRNA-reprogrammed iPSCs, secrete higher levels of immunomodulatory proteins than donor-derived MSCs, and have unique manufacturing advantages."

"We believe we have the key elements in place from a clinical design and manufacturing point of view to evaluate this novel cell therapy approach to deal with the current pandemic," said Myron Holubiak, Chief Executive Officer of Citius. "ARDS is a very serious complication for many patients suffering from COVID-19, and is believed to account for about 80% of the deaths in ventilated patients. There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management. Literature from previous investigational studies with MSCs in the treatment of lung injuries support the idea that MSCs could prove effective in treating COVID-19-related ARDS. We look forward to our FDA discussions and are excited to be at the cusp of what could be a novel and effective therapy for ARDS."

About Acute Respiratory Distress Syndrome (ARDS)ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Coronavirus Treatment Acceleration Program (CTAP)In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 will benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Novellus, Inc.Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.

Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the ability to access the FDA's CTAP program for the MARCO trial; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and our Phase III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing our product candidates, including any licensed from Novellus, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677 x105ascott@citiuspharma.com

View original content:http://www.prnewswire.com/news-releases/citius-announces-pre-ind-submission-to-fda-under-the-coronavirus-treatment-acceleration-program-for-a-novel-stem-cell-therapy-for-acute-respiratory-distress-syndrome-ards-in-covid-19-301047150.html

SOURCE Citius Pharmaceuticals, Inc.

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Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory...

Diabetes reversed in mice using CRISPR and stem cell therapy – BioNews

27 April 2020

Genome-edited human stem cells from diabetic patientshavebeen shown to successfully reverse diabetes in mice.

Researchers at Washington University School of Medicine in St Louis, Missouri, used CRISPR/Cas9 to correct a genetic defect in human stem cells and then converted them into cells capable of producing insulin. When these edited insulin-producing cells were implanted into diabetic mice, they were able to effectively control blood sugar levels for six months.

'We're excited about the fact that we were able to combine these two technologies - growing beta cells from induced pluripotent stemcells and using CRISPR to correct genetic defects,' said corresponding author Dr Jeffrey Millman. 'This is the first time CRISPR has been used to fix a patient's diabetes-causing genetic defect and successfully reverse diabetes.'

The human cells used were from a patient with a rare genetic type of diabetes called Wolfram syndrome, which develops during childhood and typically requires affected patients to inject insulin multiple times each day.

'For this study, we used cells from a patient with Wolfram syndrome because, conceptually, we knew it would be easier to correct a defect caused by a single gene. But we see this as a stepping-stone toward applying gene therapy to a broader population of patients with diabetes,' said Dr Millman.

The same team previously developed a new technique to more efficiently convert human stem cells into insulin-producing cells, allowing them to 'functionally cure' diabetes in mice for the first time (see BioNews1037). In the current study, they went one step further, adding the genome editing step to make cells from a diabetic personproduce insulin.

'We basically were able to use these cells to cure the problem, making normal beta cells by correcting this mutation,' said Dr Fumihiko Urano, who co-led the study. 'In fact, we found that corrected beta cells were indistinguishable from beta cells made from the stem cells of healthy people without diabetes,' added Dr Millman.

'It's also possible that by correcting the genetic defects in these cells, we may correct other problems Wolfram syndrome patients experience, such as visual impairment and neurodegeneration' said Dr Urano.

The study was published in the journal Science Translational Medicine.

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Diabetes reversed in mice using CRISPR and stem cell therapy - BioNews

Orchard Therapeutics Announces First Patient Dosed with OTL-201 Gene Therapy in Proof-of-Concept Clinical Trial for Sanfilippo Syndrome (MPS-IIIA) -…

BOSTON and LONDON, April 27, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the first patient has been dosed in an open-label, proof-of-concept investigational study of OTL-201, an ex vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of mucopolysaccharidosis type IIIA (MPS-IIIA). The study is designed to evaluate safety, tolerability and clinical efficacy and is intended to enroll up to five patients between three months and 24 months of age who will be followed for three years. The study also contains a number of key secondary outcome measures such as overall survival, cognition and behavior to help inform future clinical development of HSC gene therapy in this indication.

MPS-IIIA, also known as Sanfilippo syndrome type A, is a rare, inherited neurometabolic disorder caused by genetic mutations that leads to the buildup of sugar molecules called mucopolysaccharides in the body, resulting in progressive intellectual disability and loss of motor function. Children born with MPS-IIIA rarely live past adolescence or early adulthood, and no approved therapies currently exist to treat the disease.

I am very encouraged that we, together with our research and clinical collaborators in Manchester, could achieve this important milestone in our efforts to develop a gene therapy for MPS-IIIA despite the current, challenging global health circumstances, said Bobby Gaspar, M.D., Ph.D., chief executive officer of Orchard. It is a testament to the dedication of our collective teams and underscores the truly dire, life-limiting nature of the disease for affected children and their families. This study adds to Orchards clinical pipeline of HSC gene therapies for the treatment of severe neurometabolic disorders and further demonstrates the potential of our platform approach.

About MPS-IIIAMucopolysaccharidosis type IIIA (MPS-IIIA, also known as Sanfilippo syndrome type A) is a rare and life-threatening metabolic disease. People with MPS-IIIA are born with a mutation in the N-sulphoglucosamine sulphohydrolase (SGSH) gene, which, when healthy, helps the body break down sugar molecules called mucopolysaccharides. The buildup of mucopolysaccharides in the brain and other tissues leads to intellectual disability and loss of motor function. MPS-IIIA occurs in approximately one in every 100,000 live births. Life expectancy of children born with MPS-IIIA is estimated to be between 10-25 years.

About OrchardOrchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically-modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. The company has one of the deepest gene therapy product candidate pipelines in the industry and is advancing seven clinical-stage programs across multiple therapeutic areas, including inherited neurometabolic disorders, primary immune deficiencies and blood disorders, where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About OrchardInvestors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (twitter.com/orchard_tx and http://www.linkedin.com/company/orchard-therapeutics), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking StatementsThis press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals and the therapeutic potential of Orchards product candidates, including the product candidate or candidates referred to in this release. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development and commercial programs; the risk that any one or more of Orchards product candidates, including the product candidate or candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchards ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates; the delay of any of Orchards regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates or the receipt of restricted marketing approvals; and the risk of delays in Orchards ability to commercialize its product candidates, if approved. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards annual report on Form 10-K for the year ended December 31, 2019, as filed with the U.S. Securities and Exchange Commission (SEC) on February 27, 2020, as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaMolly CameronManager, Corporate Communications+1 978-339-3378media@orchard-tx.com

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Orchard Therapeutics Announces First Patient Dosed with OTL-201 Gene Therapy in Proof-of-Concept Clinical Trial for Sanfilippo Syndrome (MPS-IIIA) -...