The Proteus Effect: Stem Cells and Their Promise for Medicine

The views expressed in this book are solely those of the author(s) and do not necessarily reflect the views of the National Academies.

Ann B. Parson is a science journalist who has covered a range of topics in the areas of medicine, technology, and the environment. She is co-author of Decoding Darkness; The Search for the Genetic Causes of Alzheimer's Disease. Published in 2000, Decoding Darkness was hailed by Publisher's Weekly as a "fascinating story" and "not just another sterile account of scientific discovery." Parson is co-author as well of Menopause. She has written dozens of articles for a range of publications, among them The Boston Globe, The New York Times, McCalls, The San Diego Union-Tribune, and Harvard Health Letter. From 1990 to 1998, she taught in Boston University's graduate program in science journalism. She currently resides in South Dartmouth, Massachusetts.

The Proteus Effect; Stem Cells and Their Promise for Medicine was nominated for a LA Times Book Prize and named to Library Journals annual list of best Science-Technology books. Anns earlier books include Decoding Darkness; The Search for the Genetic Causes of Alzheimer's Disease, which she co-authored with neuroscientist Rudolph Tanzi, Harvard Medical School, and a book on womens health co-authored with Dr. Isaac Schiff, Chief of Obstetrics, Mass General Hospital. Each book was considered a leader among comparable titles.

Between 2008 & 2012 Ann wrote five commissioned family histories/biographies, each privately printed. First came three New England families: the Lymans, the Wigglesworths, and the Pickerings. Biographies of two outstanding engineers followed: Mortimer Rogoff, a pioneer of GPS and cell-phone technology; and Antonio Ferri, the unparalleled father of supersonic and hypersonic flight.

Stem cells could be the key that unlocks cures to scores of diseases and illnesses. Their story is at once compelling, controversial, and remarkable. Part detective story, part medical history, The Proteus Effect recounts the events leading up to the discovery of stem cells and their incredible potential for the future of medicine.

What exactly are these biological wonders these things called stem cells? They may be tiny, but their impact is earth shaking, generating excitement among medical researchers and outright turmoil in political circles. They are reported to be nothing short of miraculous. But they have also incited fear and mistrust in many. Indeed, recent research on stem cells raises important questions as rapidly as it generates new discoveries.

The power of stem cells rests in their unspecialized but marvelously flexible nature. They are the clay of life waiting for the cellular signal that will coax them into taking on the shape of the beating cells of the heart muscle or the insulin-producing cells of the pancreas. With a wave of our medical magic wand, its possible that stem cells could be used to effectively treat (even cure) diseases such as Parkinson's disease, diabetes, heart disease, autoimmune disorders, and even baldness.

But should scientists be allowed to pick apart four-day-old embryos in order to retrieve stem cells? And when stem cells whisper to us of immortality they can divide and perpetuate new cells indefinitely how do we respond? Stem cells are forcing us to not only reexamine how we define the beginning of life but how we come to terms with the end of life as well.

Meticulously researched, artfully balanced, and engagingly told, Ann Parson chronicles a scientific discovery in progress, exploring the ethical debates, describing the current research, and hinting of a spectacular new era in medicine. The Proteus Effect is as timely as it is riveting.

Ann B. Parson. 2004. The Proteus Effect: Stem Cells and Their Promise for Medicine. Washington, DC: Joseph Henry Press. https://doi.org/10.17226/11003.

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The Proteus Effect: Stem Cells and Their Promise for Medicine

Marker Therapeutics Reports Second Quarter 2020 Operating and Financial Results – PRNewswire

HOUSTON, Aug. 10, 2020 /PRNewswire/ -- Marker Therapeutics, Inc.(Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today provided a corporate update and reported financial results for the second quarter ended June 30, 2020.

"We continue to make progress toward advancing our planned Phase 2 trial with our novel MultiTAA-specific T cell therapy in patients with acute myeloid leukemia, or AML," said Peter L. Hoang, President & CEO of Marker Therapeutics. "While the COVID-19 pandemic has impacted hospital systems globally, we have augmented our process development for our MT-401 product, continued the buildout of our manufacturing facility and added further clinical sites for our Phase 2 AML trial. With a novel cell therapy product candidate that has demonstrated the ability to induce broad and durable immune responses in earlier clinical studies, Marker remains well-positioned to provide a potential treatment option for patients suffering from this devastating disease."

PROGRAM UPDATES

Multi-Antigen Targeted (MultiTAA) T Cell Therapies

Phase 2 AML Trial Update The Company continues to identify and add clinical trial sites in preparation for the Phase 2 AML trial initiation. The study is currently subject to a partial clinical hold on the use of a new reagent in the manufacturing processuntil the FDA reviews and accepts the final data and certificates of analysis for the new reagent. The alternate supplier has been delayed in providing the reagent but expects to ship the reagent to Marker in Q3. Once Marker receives the reagent and completes the required analyses for FDA, the Company will provide additional clarification around the timing of the AML trial enrollment.

USAN Council Approval of "Zelenoleucel" for MT-401Marker recently announced that the United States Adopted Names (USAN) Council approved "zelenoleucel" as the nonproprietary (generic) name for MT-401, a MultiTAA-specific T cell product candidate for the treatment of patients with AML following allogeneic stem cell transplant in both adjuvant and active disease settings.

Pancreatic Cancer Data Presented During ASCO Updated clinical results from an ongoing investigator-sponsored Phase 1 trial led by the Baylor College of Medicine, evaluating the Company's MultiTAA-specific T cell therapy in patients with advanced or metastatic pancreatic adenocarcinoma, were presented during the 2020 American Society of Clinical Oncology (ASCO) Virtual Annual Meeting. Data from a cohort of patients receiving MultiTAA-specific T cell therapy in combination with standard-of-care chemotherapy in the first-line setting (Arm A) were presented.

BUSINESS UPDATES

On June 30, 2020, Marker announced that the Company executed a lease agreement to establish an in-house cGMP manufacturing facility in Houston, TX. The facility is expected to be completed by year-end and operational in 2021. Marker will continue to manufacture its MultiTAA-specific T cell therapy at the Baylor College of Medicine to support the Company-sponsored AML trial until the in-house cGMP manufacturing facility is operational.

SECOND QUARTER 2020 FINANCIAL RESULTS

Cash Position and Guidance:At June 30, 2020, Marker had cash and cash equivalents of $32.1 million. The Company believes that its existing cash and cash equivalents will fund its operating expenses and capital expenditure requirements into Q2 2021.

R&D Expenses:Research and development expenses were$4.3 million for the quarter endedJune 30, 2020, compared to$3.2 million for the quarter ended June 30, 2019.

G&A Expenses:General and administrative expenses were$2.5 million for the quarter endedJune 30, 2020, compared to $2.7 million for the quarter ended June 30, 2019.

Net Loss:Marker reported a net loss of$6.3 millionfor the quarter endedJune 30, 2020, compared to a net loss of$5.6 million for the quarter ended June 30, 2019.

About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

To receive future press releases via email, please visit:https://www.markertherapeutics.com/email-alerts

Forward-Looking Statement Disclaimer This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; the impact of the COVID-19 pandemic; and the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global economy. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Marker Therapeutics, Inc. Condensed Consolidated Balance Sheets

June 30,

December 31,

2020

2019

(Unaudited)

(Audited)

ASSETS

Current assets:

Cash and cash equivalents

$ 32,124,187

$ 43,903,949

Prepaid expenses and deposits

2,632,514

1,526,442

Interest receivable

3,440

56,189

Total current assets

34,760,141

45,486,580

Non-current assets:

Property, plant and equipment, net

1,592,094

417,528

Construction in progress

2,629,141

-

Right-of-use assets, net

9,542,228

455,174

Total non-current assets

13,763,463

872,702

Total assets

$ 48,523,604

$ 46,359,282

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$ 4,528,021

$ 1,757,680

Lease liability

456,065

204,132

Warrant liability

-

31,000

Total current liabilities

4,984,086

1,992,812

Non-current liabilities:

Lease liability, net of current portion

9,025,273

280,247

Total non-current liabilities

9,025,273

280,247

Total liabilities

14,009,359

2,273,059

Commitments and contingencies

-

-

Stockholders' equity:

Preferred stock - $0.001 par value, 5 million shares authorized and 0 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

-

-

Common stock, $0.001 par value, 150 million shares authorized, 46.6 million and 45.7 million shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

46,617

45,728

Additional paid-in capital

374,828,385

371,573,909

Accumulated deficit

(340,360,757)

(327,533,414)

Total stockholders' equity

34,514,245

44,086,223

Total liabilities and stockholders' equity

$ 48,523,604

$ 46,359,282

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Marker Therapeutics Reports Second Quarter 2020 Operating and Financial Results - PRNewswire

New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 – PharmiWeb.com

Cell, Gene & Tissue-Based Therapy Developers Poised to Break Year-Over-Year Global Financing Records

WASHINGTON, D.C. August 6, 2020 The Alliance for Regenerative Medicine (ARM), the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies, today announces the publication of its H1 2020 Global Sector Report, Innovation in the Time of COVID-19. The report provides an in-depth look at trends and metrics in the gene, cell, and tissue-based therapeutic sector in the midst of the pandemic.

As the voice of the sector globally, ARM regularly publishes sector data reports to showcase clinical and scientific progress, as well as advancements and remaining challenges in the policy environment surrounding cell, gene and tissue-based therapies. The report also includes updated metrics on fundraising and clinical trials from more than 1,000 therapeutic developers worldwide.

Highlights from the H1 2020 Global Sector Report include:

Janet Lambert, CEO of ARM, commented: The regenerative medicine and advanced therapy sector has shown remarkable resilience in the face of many new challenges posed by COVID-19. Most importantly, were continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. ARM will continue to work with our membership and with policymakers in the second half of 2020 to further advance these transformative technologies. We are committed to bringing these life-changing therapies to patients in need.

This report is the latest in ARMs series of global regenerative medicine sector reports, providing up-to-date metrics on financings and the clinical landscape, as well as expert commentary on key trends and progress in the field. The full report is available online here, with key sector metrics and infographics available here. For more information, please visit http://www.alliancerm.org or contact Kaitlyn (Donaldson) Dupont at kdonaldson@alliancerm.org.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the voice of the sector, representing the interests of 360+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

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New Report: Regenerative Medicine & Advanced Therapies Sector Thriving Despite COVID-19 - PharmiWeb.com

Regenerative Medicine & Stem Cell Practice in Medical Spas …

In todays video, we talk about how medical spas and medical practices handle some of the legal issues with regenerative medicine, and stem cell therapies.

Im Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. Weve advised hundreds of healthcare industry clients on healthcare and FDA legal issues. Our clients include medical spas and healthcare companies that work with stem cell therapies and regenerative medicine.

Weve also gotten a lot of client questions about use of stem cell therapies, whether by medical doctors, naturopathic physicians, or midlevel practitioners such as RNs. As healthcare and FDA attorneys working in regulatory territory, we receive many deep-in-the-weeds questions.

For example, what about injecting stem cells for beauty and cosmetic treatments?

Using stem cells in IV infusions?

Are stem cell therapies covered within state law on nonsurgical medical cosmetic procedures?

Do stem cell therapies require an initial, in-person exam by an MD or under MD supervision by a PA or in collaboration by an NP?

What about procedures such as micro-needling, do these require medical supervision and a good faith exam?

Let me give you three tips to help you keep you in mind when youre looking to get a healthcare lawyer to address these kinds of legal questions.

First, a lot of the law simply says no. It doesnt tell you what you can do, only in broad terms what you cant do. So, when youre looking for legal advice, youre really asking for a professional read by an attorney, between the yes and the no. Obviously, either extreme is unsatisfying and doesnt give you any real guidance.

What you want in a healthcare lawyer is knowledge, skill and experience. A good healthcare lawyer can tell you, this particular scenario is more likely to get you in regulatory trouble, that scenario is more likely not going to be the biggest enforcement priority.

This week, one of our clients, a medical doctor who also runs a medical spa, told me that his biggest competitors were marketing and advertising their services, using advertising copy that he considered deceptive and misleading. He was at wits end trying to compete with these industry players who just dont follow the rules. Its not fair.

We talked through some of the strategies they were using and the legal risks that they were undertaking. Finally, he listened, and concluded: dont poke the bear. In a way, the process of mapping out the regulatory landscape helped him clarify his own business decision.

Second, a lot of these questions come under state law and they have to do with what licensing statutes, regulations, and Board policy statements say.

The federal government doesnt regulate the practice of medicine, or the healthcare practice of other licensed professionals. Rather, the United States Constitution leaves the regulation of health, safety and welfare up to the States.

And so, each State will have different laws and rules about what medical spas can do; about who can do what kinds of therapies; about whether you need a doctor to perform therapy X or Y or whether this can be done by an RN under MDs supervision; or, whether some services can and cant be performed by a licensed esthetician, because for example, they might constitute the practice of medicine.

Depending on your legal budget, it often doesnt make sense to research the law in all states, or even a lot of states. If youre a medical spa in one location, then obviously, your state law matters; and if your business is multi-state, sometimes we focus on key states or we get a small sampling of the ones with the toughest rules.

My third tip is, dont rely on advice which you got from someone else, because it is often incorrect, and based on facts and circumstances that dont necessarily apply to your situation.

As an example, recently, one medical spa came to our Firm with all of these questions swirling around in their minds. They were worried, because a medical spa in the same neighborhood had been visited by a very, very, super friendly medical board investigator, who was asking too many questions, in too friendly a way; and across town, medical spas had been raided by enforcement officials in a very heavy-handed way.

Up till then, the medical spa had thought it was legally safe, because, after all, it had a HIPAA-compliant software platform, and had its doctor making remote Skype calls with patients, before the RN would initiate a whole host of regenerative medicine therapies.

This kind of scenario in fact created much regulatory jeopardy.

The medical spa client basically told us: we use stem cells we get here from Company X, we mix them up in the back of our office with formula Y, then we inject them here and there as the doctor emails us, were only doing it for beauty, we think its ok, we just want some clarification on the laws.

OK, so if the speed limit is 55 and Im going 90, but Im telling you its ok because Im driving an old Chevy, my seat belt if fastened, I have a radar detector, and Ive also surrounded myself with white light and asked the angels to protect me which by the way is not a bad idea, but dont rely on it when you go 90 because if I drive too fast and I have a long way to go and I want to get there quickly all I want to know is, i just want to know if am I legally ok I mean, my cousins lawyers half-sisters friend, who swears by this and also asked a lawyer, said it was ok, as long as I dont go over 90 miles an hour .

I know it sounds really silly, but its the sort of thing we hear, in one form or another all the time.

And thats why you cant take excuses, and your healthcare lawyers experience and professional lens can help you interpret the law.

Thanks for watching. Heres to the success of your healthcare venture, we look forward to speaking with you soon.

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Regenerative Medicine & Stem Cell Practice in Medical Spas ...

Global Stem Cell Therapy Market Research Analysis Including Growth Factors, Types And Application By Regions From 2020 To 2024 – Owned

Global Stem Cell Therapy Market Analysis to 2024 is a focused and comprehensive study of the Stem Cell Therapy industry with a focus on the global market trend. The information mentioned in the Global Stem Cell Therapy Market research report presents an overview of the latest trends observed in the global market. Besides, this report emphases on the latest events such as the technological developments and the product launches and their consequences on the Market. The research report delivers the global market revenue, parent market trends along with market attractiveness per market segment.

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Top Players of Stem Cell Therapy Market are:

Osiris Therapeutics NuVasive Chiesi Pharmaceuticals JCRPharmaceutical Pharmicell Medi-post Anterogen Molmed Takeda (TiGenix) Regional Stem Cell Therapy Market (regional production, demand and forecast by country):

The main goals of the research report elegant the overall market overview on Stem Cell Therapy market dynamics, historic volume and value, robust market methodology, Latest and future trends, Porters Five Forces Analysis, new technological development, cost structure, government policies and regulations, etc. Major companies, company overview, financial data, products and services, strategy analysis, key developments market competition, industry competition structure analysis, SWOT Analysis, etc.

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KEY MARKET SEGMENTS

On the basis of types, the Stem Cell Therapy Market is primarily split into:

Autologous Allogeneic On the basis of applications, the Stem Cell Therapy Market covers:

Musculoskeletal Disorder Wounds & Injuries Cornea Cardiovascular Diseases Others

Which market factors are explained in the report?

Study Coverage:Covers significant companies, vital market segments, the scope of the products offered in the global Stem Cell Therapy market, the years considered and the study objectives.

Executive Summary:It contains a summary of the most important studies, the Stem Cell Therapy market growing rate, modest conditions, market drivers, trends and problems as well as macroscopic indicators.

Production by region:This Stem Cell Therapy report provides information on imports and exports, production, sales and key players in all examined regional markets.

Manufacturer Profile:Each Company defined in this section is screened based on a SWOT analysis, products, value, their capacity and other important factors.

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Table of Contents

1 Stem Cell Therapy Market Overview

2 Global Stem Cell Therapy Competition by Manufacturers

3 Global Stem Cell Therapy Capacity, Revenue (Value) by Region)

4 Global Stem Cell Therapy Supply (Production), Export, Import by Region

5 Global Stem Cell Therapy Market Revenue (Value), Price Trend by Type

6 Global Stem Cell Therapy Market by Application

7 Global Stem Cell Therapy Company Profiles

8 Industrial Chain, Sourcing Strategy and Downstream Buyers

9 Stem Cell Therapy Market Effect Factors Analysis

10 Global Stem Cell Therapy Market Forecast

11 Research Findings and Conclusion

12 Appendix

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Global Stem Cell Therapy Market Research Analysis Including Growth Factors, Types And Application By Regions From 2020 To 2024 - Owned

Dad with incurable cancer takes on 300 mile cycle challenge ahead of stem cell transplant – HeraldScotland

A FATHER-of-two with a rare and incurable cancer is to take on a cycle challenge ahead of a potentially life-changing stem cell transplant.

Andrew Slorance, 49, was first diagnosed with mantle cell lymphoma, a member of the non-Hodgkins lymphoma family in 2015 and had since gone on to have one transplant.

However, while he has been on a cocktail of drugs to help suppress the cancer, which is incurable, he needs to undergo a second transplant this time with a stem cell donor transplant.

His operation is now scheduled to go ahead later this year following a slight delay with the impact of coronavirus, but before then he will be saddling up for a 300-mile bike challenge in aid of Cancer Research UK next month.

I didnt think I would see my 50th birthday at one point following my diagnosis, but with developments in medicine and science I have benefited, said Mr Slorance. The cycle challenge is a way of giving back and helping to raise money for much-needed research which could save lives. It is also a chance for me to get out on the bike and keep me fit for my next operation.

Mr Slorance thought he was just recovering from a gastric flu in summer 2015, but after still feeling tired and sluggish he decided to get checked out.

Following tests I was told I had a rare and incurable cancer called mantle cell lymphoma. By December, I was undertaking a gruelling four-month programme of chemotherapy before a life-prolonging stem cell transplant in spring 2016. At the time of diagnosis, the average life expectancy for MCL wasnt great, but science and luck have been on my side.

Last year, Mr Slorance relapsed but has benefited from a new drug that is controlling his current cancer ahead of his big operation in January next year.

He added: It wont last forever, though, and I need to face another stem cell transplant, this time the much more riskier donor or allogeneic transplant. If it goes well it could prove curative. But if it fails, well then that is another story. The drugs wont control the cancer forever so it is about getting to the point to make sure you can get the benefit of the drugs before going for the transplant.

With this one being a donor transplant there could be more chance of rejection like with any organ transplant, but the long-term benefits could be much greater. They cant say absolutely at the stage that the transplant is curative.

While waiting for his transplant date, Mr Slorance had found focusing on the cycle challenge and it has been all the more enjoyable being able to get out as shielding restrictions eased. He has been working from home in his role for the Scottish Government and had to take precautions in the family home.

Mr Slorance added: With four of us in the house we had to look at ways of socially distancing.

I was sleeping and working in a bedroom and judged my meal times separately from the family. It was great to get out in the garden, but even then I would have my own little area while the others would have theirs.

It has certainly been hard in these times when no-one has been able to hug one another.

Mr Slorance has been building up his mileage daily and is attempting to cover the 300 miles this month in case he cant manage in the official month of September.

After three months of shielding I finally got out for exercise on June 18. Ive bought myself an electric bike. Not as a cheat but because it helps to neutralise the many hills around my Edinburgh home.

The pills I am taking have a side-effect that can cause joint pain. I have also been sleeping on a bed settee since March. Those things combined have left me with excruciatingly painful and uncomfortable knees and shoulders.

Without the extra help of an electric bike theres no way Id be able to manage the effort needed to tackle the climbs, but I do put a lot of effort in on the flat.

Already he has been building up from seven miles a day while returning to his commute and has already raised more than 3,000.

Mr Slorance said: I hope I can raise as much money as I can for Cancer Research UK. Charities have been affected by lockdown and raising money has not been easy. In the past I have raised money for Maggies Centres, but this seemed a good way to help.

I already owe my extended life to cancer research and new treatments, but the median survival rate for MCL has only increased to six to seven years, so I could really benefit from more scientific advances.

To donate go to fundraise.cancerresearchuk.org/page/andrews-cycle-300-fundraising-page-202

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Dad with incurable cancer takes on 300 mile cycle challenge ahead of stem cell transplant - HeraldScotland

Potential Impact of COVID-19 Pandemic on Global Stem Cell Assay Coronavirus Impact Editon of Key Companies Merck, Thermo Fisher Scientific, GE…

Report is a detailed study of the Stem Cell Assay market, which covers all the essential information required by a new market entrant as well as the existing players to gain a deeper understanding of the market.The primary objective of this research report named Stem Cell Assay market is to help making reliable strategic decisions regarding the opportunities in Stem Cell Assay market. It offers business accounts, industry investors, and industry segments with consequential insights enhancing decision making ability.nicolas.shaw@cognitivemarketresearch.com or call us on +1-312-376-8303.

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Global and Regional Stem Cell Assay Market Segmentation by Type: Viability, Purification, Identification

Global Stem Cell Assay Market Segmentation by Applications: Regenerative Medicine, Clinical Research

Major Market Players with an in-depth analysis: Merck, Thermo Fisher Scientific, GE Healthcare, Agilent Technologies, Bio Rad Laboratories, Promega, Cell Biolabs, PerkinElmer, Miltenyi Biotec, HemoGenix, Bio Techne, STEMCELL

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The Stem Cell Assay market report offers the current state of the market around the world. The report starts with the market outline and key components of the Stem Cell Assay market which assumes a significant job for clients to settle on the business choice. It additionally offers the key focuses to upgrade the development in the Stem Cell Assay market. Some fundamental ideas are likewise secured by reports, for example, item definition, its application, industry esteem chain structure and division which help the client to break down the market without any problem. Also, the report covers different factors, for example, arrangements, efficient and innovative which are affecting the Stem Cell Assay business and market elements.

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The research comprises primary information about the products. Similarly, it includes supply-demand statistics, and segments that constrain the growth of an industry. It also includes raw materials used and manufacturing process of Stem Cell Assay market. Additionally, report provides market drivers and challenges & opportunities for overall market in the particular provincial sections.

Competitive Analysis has been done to understand overall market which will be helpful to take decisions. Major players involved in the manufacture of Stem Cell Assay product has been completely profiled along with their SWOT. Some of the key players include Merck, Thermo Fisher Scientific, GE Healthcare, Agilent Technologies, Bio Rad Laboratories, Promega, Cell Biolabs, PerkinElmer, Miltenyi Biotec, HemoGenix, Bio Techne, STEMCELL. It helps in understanding their strategy and activities. Business strategy described for every company helps to get idea about the current trends of company. The industry intelligence study of the Stem Cell Assay market covers the estimation size of the market each in phrases of value (Mn/Bn USD) and volume (tons). Report involves detailed chapter on COVID 19 and its impact on this market. Additionally, it involves changing consumer behavior due to outbreak of COVID 19.

Further, report consists of Porters Five Forces and BCG matrix as well as product life cycle to help you in taking wise decisions. Additionally, this report covers the inside and out factual examination and the market elements and requests which give an entire situation of the business.

Regional Analysis for Stem Cell Assay North America (United States, Canada) Europe (Germany, Spain, France, UK, Russia, and Italy) Asia-Pacific (China, Japan, India, Australia, and South Korea) Latin America (Brazil, Mexico, etc.) The Middle East and Africa (GCC and South Africa)

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Chapters Define in TOC (Table of Content) of the Report: Chapter 1: Market Overview, Drivers, Restraints and Opportunities, Segmentation Overview Chapter 2: COVID Impact Chapter 3: Market Competition by Manufacturers Chapter 4: Production by Regions Chapter 5: Consumption by Regions Chapter 6: Production, By Types, Revenue and Market share by Types Chapter 7: Consumption, By Applications, Market share (%) and Growth Rate by Applications Chapter 8: Complete profiling and analysis of Manufacturers Chapter 9: Manufacturing cost analysis, Raw materials analysis, Region-wise Manufacturing expenses Chapter 10: Industrial Chain, Sourcing Strategy and Downstream Buyers Chapter 11: Marketing Strategy Analysis, Distributors/Traders Chapter 12: Market Effect Factors Analysis Chapter 13: Market Forecast Chapter 14: Stem Cell Assay Research Findings and Conclusion, Appendix, methodology and data source To check the complete Table of Content click here: @ https://cognitivemarketresearch.com/medical-devicesconsumables/stem-cell-assay-market-report#table_of_contents

The qualitative contents for geographical analysis will cover market trends in each region and country which includes highlights of the key players operating in the respective region/country, PEST analysis of each region which includes political, economic, social and technological factors influencing the growth of the market. The research report includes specific segments by Type and by Application. This study provides information about the sales and revenue during the historic and forecasted period of 2015 to 2027.

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Potential Impact of COVID-19 Pandemic on Global Stem Cell Assay Coronavirus Impact Editon of Key Companies Merck, Thermo Fisher Scientific, GE...

BCLI: Phase 3 ALS Data Expected by the End of November 2020 – Zacks Small Cap Research

By David Bautz, PhD

NASDAQ:BCLI

READ THE FULL BCLI RESEARCH REPORT

Business Update

Topline Data from Phase 3 ALS Trial Before End of November 2020

BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) is currently conducting a Phase 3 clinical trial of NurOwn in patients with amyotrophic lateral sclerosis (ALS) (NCT03280056). A total of 200 patients were randomized 1:1 to receive NurOwn or placebo in the randomized, double blind, placebo controlled, multi-dose trial. Cells were extracted once from each patient prior to treatment, with all administrations of NurOwn derived from the same extraction of cells due to a cryopreservation process the company developed for long-term storage of mesenchymal stem cells (MSC). Just as with the companys prior studies, there was a 3-month run-in period prior to the first treatment with two additional NurOwn treatments occurring two and four months following the first treatment. The company is focusing the trial on faster-progressing ALS patients since those patients demonstrated superior outcomes in the Phase 2 trial of NurOwn. The primary outcome of the trial is the ALSFRS-R score responder analysis and we now anticipate topline results before the end of November 2020.

Update on Phase 2 Progressive Multiple Sclerosis Trial

BrainStorm is currently conducting a Phase 2 clinical trial of NurOwn in patients with progressive multiple sclerosis (MS) (NCT03799718). The trial is an open label, single arm study that is enrolling patients with progressive MS with Expanded Disability Status Scale (EDSS) scores of 3.0 6.5. The primary endpoint of the study is the safety and tolerability of three doses of NurOwn with secondary endpoints examining the timed 25-foot walking speed or 9-hole peg test (both validated MS clinical outcome assessments) along with paired cerebrospinal fluid (CSF) and blood biomarker analysis. The National Multiple Sclerosis Society awarded the company a $0.5 million grant to help fund the study.

The trial is now fully enrolled and we anticipate dosing to be completed for all patients by the end of 2020. While the company had previously considered performing an interim analysis, since topline data would be available soon after an interim analysis could be performed the company has decided against performing an interim analysis and will instead report topline data for all 20 patients when it becomes available.

NurOwn Derived Exosomes Show Promise in Preclinical ARDS Study

On July 23, 2020, BrainStorm announced the successful completion of the first milestone in developing an exosome-based platform for the treatment of severe acute respiratory distress syndrome (ARDS) caused by COVID-19. Exosomes are small vesicles (30-150 nm) that are secreted by all cell types. Exosomes from mesenchymal stem cells (MSCs), from which NurOwn is derived, can penetrate into deep tissues and deliver various bioactive molecules. In addition, they can be delivered both intravenously or intratracheally.

BrainStorm conducted a preclinical study of MSC-derived exosomes in a mouse model of lipopolysaccharide (LPS)-induced ARDS. Treatment with intratracheally administered exosomes resulted in a statistically significant improvement in various lung functions, including functional lung recovery and decreased lung damage, as judged by the lung disease severity score (P=0.03). In addition, they led to a reduction in a number of pro-inflammatory cytokines. Lastly, exosomes derived from MSC-NTF cells were superior to exosomes derived from nave MSC from the same donor.

We anticipate the results being submitted to a peer reviewed journal for publication and the company is currently deciding whether to initiate a clinical trial program in COVID-19 patients with ARDS.

Financial Update

On August 5, 2020, BrainStorm announced financial results for the second quarter of 2020. As anticipated, the company did not report any revenues during the second quarter of 2020. Net R&D expenses for the second quarter of 2020 were $5.7 million, compared to $3.6 million for the second quarter of 2019. The increase was primarily due to an increase in payroll and stock-based compensation and a decrease in support from the Israel Innovation Authority (IIA) and California Institute for Regenerative Medicine (CIRM) along with a decrease in costs related to the Phase 3 and Phase 2 clinical trials. Excluding participation from the IIA and CIRM, R&D expenses were $6.0 million in the second quarter of 2020, compared to $6.5 million in the second quarter of 2019. G&A expenses for the second quarter of 2020 were $1.7 million, compared to $1.3 million in the second quarter of 2019. The increase was primarily due to increased payroll and stock-based compensation.

The company exited the second quarter of 2020 with approximately $16.2 million in cash, cash equivalents, and short-term investments. Subsequent to the end of the quarter, the company raised gross proceeds of approximately $13.7 million from the $50 million ATM facility entered into in March 2020 through the sale of 945,082 shares at an average price of $14.48 per share. In addition, the company raised gross proceeds of approximately $6.3 million from the exercise of warrants. We estimate that the company currently has approximately $35 million in cash, cash equivalents, and short-term investments.

As of July 31, 2020, the company had approximately 31.5 million shares outstanding and, when factoring in warrants and stock options, a fully diluted share count of approximately 37.0 million.

Conclusion

The countdown is on to the topline data release for the Phase 3 ALS trial, with those results expected before the end of November 2020. Even with the great run the stock has had since its recent lows in March 2020, we continue to view the shares as undervalued as we currently forecast peak sales for NurOwn of >$1 billion in ALS, >$500 million in MS, and >$2 billion in Alzheimers disease. We recently made a slight change to our model, in which we decreased the discount rate from 17% to 13%, and combined with the recent financing activity has resulted in an increase to our valuation to $33 per share.

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BCLI: Phase 3 ALS Data Expected by the End of November 2020 - Zacks Small Cap Research

Types of Stem Cell Transplantation | Stem Cell …

Stem cells for transplantation can be collected from the blood, bone marrow or umbilical cord blood. The Packard Childrens Hospitals Stem Cell Transplant program offers a full range of stem cell transplantation options:

Autologous stem cell transplant Healthy stem cells are collected from the patient's own blood or marrow. After treatment, the stored stem cells are infused into the patients blood. The healthy stem cells then find their way to the bone marrow and begin to produce new, healthy cells.

Allogeneic stem cell transplant Healthy stem cells are collected from a related or unrelated donor. New, healthy donor stem cells help restore the blood-forming cells of the patients bone marrow.

Anallogeneic relateddonors stem cells genetically match, as close as possible, that of the patient. The donor may be a brother, sister or parent. Siblings have a 1 in 4 chance of being a match. The degree to which the donor's and patient's tissue match is done by a blood test called HLA typing.

Anallogeneic unrelated donor (URD)is not related to the patient but has similar genetic typing. TheNational Marrow Donor Program (NMDP) makes it possible to find similar matches for patients that do not have a related donor. The NMDP registry is comprised of volunteer donors. New donors are added to the list daily.

Haploidentical stem cell transplant Healthy stem cells are collected from a parent or a related or unrelated donor. This provides a genetic match that is at least half identical to the recipient.

Syngeneic stem cell transplant An identical twin is the stem cell donor. Identical twins have identical genetic types and are a perfect match.

Peripheral stem cell transplant Stem cells are collected from the peripheral blood by apheresis. Apheresis is a process where blood is removed from the patient via an IV catheter, the stem cells are selected out by a machine, and the remainder of the blood is returned to the patient. The process takes 3-4 hours/day for 2-5 days total. The peripheral blood stem cells are most often used in the autologous setting where patients receive their own stem cells.

Cord blood stem cell transplant Stem cells are collected from the umbilical cord/placenta immediately following birth. The cells can be stored (frozen) for future use. This can be from a sibling or unrelated donor. We currently perform related or unrelated cord blood transplants in our program.

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Types of Stem Cell Transplantation | Stem Cell ...

Mesoblasts share price gained another 16% in July. Heres why. – Motley Fool Australia

Motley Fool Australia Share Market News Mesoblasts share price gained another 16% in July. Heres why.

Bernd Struben | August 7, 2020 2:07pm | More on: MSB ASX 200

Biotechnology company Mesoblast limiteds (ASX: MSB) share price added to the strong gains it notched up from April through June, closing up another 16.3% in July. An impressive performance considering the S&P/ASX 200 Index (ASX: XJO) only gained 0.5% in July.

Mesoblasts share price was hammered badly in the wider market sell-off during early COVID-19 lockdown measures, tumbling a gut-wrenching 60% from 23 February through its low on 24 March.

Since its 23 March low, Mesoblasts share price has come roaring back, up 241% by 31 July.

Year-to-date Mesoblasts share price is up 115%, giving the company a market cap of $2.6 billion.

Mesoblast is a regenerative medicine company developing treatments for inflammatory ailments, cardiovascular disease and back pain.

Mesoblast uses its proprietary technology platform to develop and commercialise innovative allogeneic cellular medicines to treat complex diseases. The company targets diseases that are resistant to a conventional standard of care and where inflammation plays a central role.

Mesoblast has four phase-3 products nearing registration:

Mesoblasts share price benefited from the companys involvement in treating COVID-19.

In the first week of July, Mesoblast released a promising update on its allogeneic mesenchymal stem cell (MSC) product candidate, remestemcel-L.

The company reported an expanded access protocol (EAP) had been initiated in the United States for the compassionate use of remestemcel-L. Patients who tested positive for the virus aged between 2 months and 17 years with pre-existing cardiovascular issues could access remestemcel-L within 5 days of referral under the EAP.

Mesoblasts financial performance has also been strong. The company recorded a 113% increase in overall revenues for the first 9 months of the 2020 financial year, compared to the first 9 month of the 2019 financial year. Mesoblasts balance sheet was also fortified by a $138 million fund raising in May. The companys next earning report is scheduled to be released on 27 August.

Mesoblasts share price has continued to run higher, up 16% so far in August.

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Motley Fool contributor Bernd Struben has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

Bernd Struben earned his economics degree in the US. Following several years writing about the tourism industry in the Caribbean, he moved to The Netherlands to cover the EUs booming commercial real estate markets. He moved to Australia in 2010, where he transitioned to analysing the Aussie equity markets. He employs a combination of macro economics and company specific data to gauge what he believes are tomorrows best investments. In his free time, youre likely to find Bernd at the beach or dabbling away on a new work of science fiction.

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Mesoblasts share price gained another 16% in July. Heres why. - Motley Fool Australia