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Australian Therapeutic Goods Administration Approves the First Phase I Trial of ATG-017 for the Treatment of Patients with Advanced Solid Tumors and…

SHANGHAI and MELBOURNE, Australia, Aug.12, 2020 /PRNewswire/ -- Antengene Corporation, a leading innovative hematology and oncology-focused biopharmaceutical company, announced today the authorization of the first-in-human trial of ATG-017 (ERASER trial) by the Australian Therapeutic Goods Administration (TGA). ATG-017 is a potent and selective small molecule extracellular signalregulated kinases 1 and 2 (ERK1/2) inhibitor. The study will enroll patients with advanced solid tumors and hematological malignancies. Today's milestone marks the first TGA trial authorization for Antengene and is the first clinical trial for ATG-017 globally.

ATG-017 is an oral, potent and highly selective inhibitor of ERK1/2, which are related protein-serine/ threonine kinases that function as the terminal kinases in the RAS-RAF-MEK-ERK signal transduction cascade. This pathway participates in the control of numerous processes which include apoptosis, cell proliferation, and cellular immune response. In preclinical studies, ATG-017 has proven to regulate a large variety of cellular processes by targeting ERK1/2 and has shown to be effective in inhibiting the viability of tumor cell lines in vitro as well as the tumor growth in vivo.

"This first human trial for ATG-017 in Australia is a significant step for our company's global clinical strategy and we will initiate overseas trials continuously for a number of novel drugs in our pipeline in the near future," said Dr. Jay Mei, M.D., Ph.D., Founder, Chairman and CEO of Antengene. "Our vision is to treat patients beyond borders. For Australian patients with life-threatening diseases and patients around the world, we are passionately working to continue to develop and commercialize more novel therapies to make a difference in patient lives."

"Aberrations in the MAPK pathway are amongst the most common in malignant cancer, so developing effective drugs targeting this pathway remains a high priority. We are excited to begin this trial with the ERK-targeting agent ATG-017, and bring together our group of highly experienced Australian investigators and sites to begin this collaboration with Antengene," said Associate Professor Jayesh Desai, Head of the Phase I/ Early Drug Development Program at the Peter MacCallum Cancer Centre.

"The RAS-MAPK pathway is a major player in a range of largely incurable hematological malignancies, so the potential to effectively target it with ATG-017 represents an exciting opportunity for Australian cancer patients. We very much look forward to collaborating with Antengene on this new trial," said Professor Andrew Spencer, Head of the Malignant Haematology and Stem Cell Transplantation Service at the Alfred Hospital, Melbourne.

In November 2019, Antengene entered into a licensing agreement with AstraZeneca (LSE/STO/NYSE: AZN) under which Antengene has been granted the exclusive global rights to further develop, manufacture and commercialize AZD0364 (ATG-017).ATG-017 is currently being studied in clinical trials for the treatment of various solid tumors and hematological malignancies.

About ATG-017

ATG-017 is a potent and selective small molecule extracellular signalregulated kinases 1 and 2 (ERK1/2) inhibitor in clinical development for the treatment of various solid tumors, non-Hodgkin's lymphoma, acute myeloid leukemia (AML) and multiple myeloma.

About Antengene

Antengene is a biopharmaceutical company with integrated drug discovery, clinical development, manufacturing and commercialization anchored in the Asia Pacific region and with a global layout, aiming to provide the most advanced first-in-class/best-in-class anti-cancer drugs and other treatments for patients in China, the rest of Asia and around the world. In April 2017, Celgene (now Bristol-Myers Squibb), a global leading innovative biopharmaceutical company became a founding partner and obtained an equity position as an investor in Antengene. Antengene has built a product pipeline of 12 clinical and pre-clinical stage programs, obtained 9 IND approvals with9 ongoing cross-regional clinical trials in the Asia Pacific region. The vision of Antengene, "Treating Patients Beyond Borders", is to meet the unmet medical needs of patients in the Asia Pacific region and around the world through our research & development and commercialization of first-in-class/best-in-class cancer medicines. For more information, please visit http://www.antengene.com.

Forward-looking Statement

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

SOURCE Antengene Corporation

http://www.antengene.com

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Australian Therapeutic Goods Administration Approves the First Phase I Trial of ATG-017 for the Treatment of Patients with Advanced Solid Tumors and...

Drug development for severe respiratory diseases supported with $3.9 million grant – Washington University School of Medicine in St. Louis

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New drug candidate targets asthma, COPD, other progressive lung diseases

Shown is a section of mouse lung with progressive lung disease, similar to asthma or COPD. The red staining shows excess mucus production that is characteristic of progressive lung disease and can occur in the aftermath of viral infection or other injury to the lungs. Researchers at Washington University School of Medicine in St. Louis have received a grant to develop a drug to block this process, potentially leading to a new treatment for debilitating lung disorders.

Researchers at Washington University School of Medicine in St. Louis have received a $3.9 million development award supporting new technologies and therapeutics to advance a first-in-class drug to treat debilitating lung diseases, including asthma and chronic obstructive pulmonary disease (COPD).

The research, funded by the Department of Defense, is led by Michael J. Holtzman, MD, the Selma and Herman Seldin Professor of Medicine and director of the Division of Pulmonary & Critical Care Medicine at Washington University.

Holtzmans team has designed a new drug candidate that blocks two important signaling systems in the lungs. These systems cause cells of the respiratory tract to become mucus-producing cells. An overabundance of these cells creates too much mucus, which can block breathing. Evidence suggests that the drug could stop and perhaps even reverse progressive damage from overproduction of mucus that is triggered by aggravations to the lung, including from respiratory viruses, smoking and air pollution.

Obstructive lung diseases, such as asthma and COPD, are the third leading cause of death due to disease in the United States, Holtzman said. But we have no effective treatments that address the root causes of these illnesses or halt disease progression. We can only try to relieve symptoms. This grant will allow us to continue research into a new drug candidate that our group developed and that has shown evidence of stopping and correcting what goes wrong in the lungs when this type of disease process is triggered.

In past research, Holtzman and his colleagues identified specialized stem cells in the lungs that give rise to mucus cells. During development, such stem cells are responsible for growing the lung itself. Some of these stem cells remain in the lungs into adulthood and periodically make new cells to line the inner surfaces of lung tissue, including those cells that make mucus. These stem cells also respond to injury to the lung such as a burn injury from inhaling smoke or a severe viral infection and orchestrate the repair process.

Shown is a section of healthy mouse lung.

We need a certain level of mucus to protect the lungs from viruses or particles that can be inhaled, Holtzman said. The stem cell population is important in maintaining normal lung function and in injury situations, where they help with the healing process. But, unfortunately, in some people these cells can go off the rails. Under certain conditions, particularly a severe respiratory viral infection, these stem cells become reprogrammed so that theyre activated even after the injury or infection is resolved. This leads to overproduction of mucus and excessive inflammation that can interfere with lung function with airway obstruction and difficulty breathing.

The new drug candidate is being designed to be taken by mouth or inhalation and to specifically target two related but distinct signaling molecules known as MAP kinases to control both arms of the immune and inflammatory response. Studying human cells, as well as mouse and pig models of respiratory disease following respiratory viral infections, the researchers found that not only does the drug reduce mucus production, it also nudges the rogue stem cells back toward their quieter and healthier state of readiness. The new grant will support studies in human cells, mice and pigs to establish evidence for the safety and effectiveness of the lead drug candidate and to help determine proper doses for subsequent studies in people. The safety work also will be facilitated by a subcontract to the teams biotechnology company known as NuPeak Therapeutics, which is specially designed for this drug development activity. The goal is to gather data to support approval for a first-in-human clinical trial.

Holtzman said the drug does not treat the viral infection itself; rather, it stops what he calls post-viral disease and its progression, which includes asthma and COPD. Post-viral lung disease also could include COVID-19, as an example of another severe respiratory viral infection that causes progressive and in some cases long-term lung disease in some patients well after the infectious virus has been cleared.

SARS-CoV-2, the virus that causes COVID-19, is similar to the viruses Holtzman and colleagues are working with to study their new drug candidate. The group is gathering key information in patient and animal models to determine whether the same therapeutic strategy could prove useful in treating COVID-19 as it has been for lung disease due to other related respiratory viruses.

Were just beginning to learn how the body responds to SARS-CoV-2, but it is very common for any respiratory viral infection, especially severe infections, to trigger this progressive disease process in some percentage of the patients who contract the virus, Holtzman said. Whats interesting is that the infectious form of the virus is gone when this process ramps up. Patients arent fighting the virus any more, theyre fighting their own immune system. In future work, we will be interested in finding out whether our drug candidate can help shut this process down regardless of the trigger, viral or otherwise.

This work is supported by the Department of Defense, grant number PR190726. Holtzman founded the biotechnology company NuPeak Therapeutics, which is facilitating development of the drug candidate.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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Drug development for severe respiratory diseases supported with $3.9 million grant - Washington University School of Medicine in St. Louis

Joliet cancer patient celebrated his 2nd birthday at home after all – The Herald-News

Owen Buell of Joliet spent his second birthday with his family after all.

In a Facebook message late Monday night, his great-grandmother Jackie Moore of Florida said Owens oncologist wound up giving Owen a day pass."'

Owen was supposed to be discharged from the Ann & Robert H. Lurie Childrens Hospital of Chicago on Monday but that was delayed due to the riots, Moore said.

He got his little party right before the storm blew through, Moore said. Better late than never.

Owen returned to the hospital on Tuesday morning where he was officially discharged. Moore said.

In February, Owen was diagnosed with a neuroblastoma, a type of cancer most commonly found in children age 5 or younger.

Before the cancer was diagnosed, Owen had stopped eating and drinking and began screaming and crying inconsolably.

His right eye looked bruised and was drooping; his abdomen had swollen to nearly double in size.

Since then, Owen's had chemotherapy and the first of two stem cell transplants.

He's also had a feeding tube, numerous ports, bone marrow tests, stem cell extractions, major abdominal surgery, according to The Help for Baby Owen Buell and his Family Facebook page, which Moore moderates.

"Throughout all of these frightening medical treatments, he has smiled and wanted to give loves to everyone," his GoFundMe page said.

Owen had spent the last week or so at a Ronald McDonald House in Chicago so he could be near the hospital, Moore said.

"I was so happy at how good they took care of him there," Moore said of Ronald McDonald House.

Although Moore was not able to fly to Illinois for Owen's birthday celebration, she did ship a 3-foot-tall stuffed llama to Owens home to because Owen really likes llamas, she said.

He had some really nice gifts, including the llama, but he was most interested in a bottle of bubbles from the dollar store, Moore wrote. Go figure.

In a few weeks, Owen will resume his cancer treatments in preparation for a second stem cell transplant, Moore said.

The goal of the transplant is to make his bones more receptive to the chemo and possibly have him go into remission, according to the Help for Baby Owen Buell and his Family Facebook page.

The medical bills for Owen's care are now over $1 million, according to the

"Help for baby Owen Buell and his Family"GoFundMe page at bit.ly/2S7sPN7.

Visit the "Help for Baby Owen Buell and His Family" Facebook page for updates and detailed instructions on other ways to help the family.

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Joliet cancer patient celebrated his 2nd birthday at home after all - The Herald-News

Stem Cell Therapy Market Size, Share, Global Future Trend, Segmentation, Business Growth, Top Key Players, Opportunities and Forecast to 2027 – Owned

New Jersey, United States,- The latest report published by Market Research Intellect on Stem Cell Therapy Market provides crucial market insights along with detailed segmentation analysis. The report examines key driving factors that are expected to drive the growth of the market.

Global Stem Cell Therapy Market Research Report gives knowledgeable information on various market situations, for example, potential development factors, factors controlling the development, market opportunities, and dangers to the worldwide market. Also, the report broadly centers around the competitive analysis of Stem Cell Therapy Market. The competitive analysis segment incorporates key manufacturers, fresh players, providers, market strategies, potential chances, operation landscape, and analysis of the trends of the Stem Cell Therapy market. The market results are centered around the current market scenario. To gauge and predict the degree of competition in this market. This report will likewise support all the manufacturers and speculators to have a superior comprehension of the investments to know where the market is heading.

Key highlights from COVID-19 impact analysis:

Unveiling a brief about the Stem Cell Therapy market competitive scope:

The report includes pivotal details about the manufactured products, and in-depth company profile, remuneration, and other production patterns.

The research study encompasses information pertaining to the market share that every company holds, in tandem with the price pattern graph and the gross margins.

Stem Cell Therapy Market, By Type

Stem Cell Therapy Market, By Application

Other important inclusions in the Stem Cell Therapy market report:

A brief overview of the regional landscape:

Reasons To Buy:

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Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage, and more. These reports deliver an in-depth study of the market with industry analysis, the market value for regions and countries, and trends that are pertinent to the industry.

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Stem Cell Therapy Market Size, Share, Global Future Trend, Segmentation, Business Growth, Top Key Players, Opportunities and Forecast to 2027 - Owned

UPDATED: Moderna offers steep discount in US supply deal but still takes the crown with close to $2.5B in vaccine contracts – Endpoints News

BioNTech execs say theyre on track to get their late-stage data on a Covid-19 vaccine partnered with Pfizer into the hands of regulators as early as October.

In their Q2 release Tuesday morning, the biotech reported that investigators could have late-stage data as early as October, and they wont be wasting any time in hustling that over to the FDA.

I am incredibly proud of our team, who has worked tirelessly to initiate our BNT162 Phase 2b/3 trial in record time and put us in a position to seek regulatory review as early as October of this year, if our trials are successful, said Ugur Sahin, BioNTechs CEO and co-founder.

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UPDATED: Moderna offers steep discount in US supply deal but still takes the crown with close to $2.5B in vaccine contracts - Endpoints News

Cell Therapy Technologies Market Research Report by Product, by Process, by Cell Type, by End User – Global Forecast to 2025 – Cumulative Impact of…

NEW YORK, Aug. 12, 2020 /PRNewswire/ -- Cell Therapy Technologies Market Research Report by Product (Consumables, Equipment, and Systems & Software), by Process (Cell Preservation, Distribution, and Handling, Cell Processing, and Process Monitoring and Quality Control), by Cell Type, by End User - Global Forecast to 2025 - Cumulative Impact of COVID-19 Read the full report: https://www.reportlinker.com/p05913782/?utm_source=PRN

The Global Cell Therapy Technologies Market is expected to grow from USD 11,492.28 Million in 2019 to USD 24,683.74 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 13.58%.

Market Segmentation & Coverage: This research report categorizes the Cell Therapy Technologies to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Product, the Cell Therapy Technologies Market studied across Consumables, Equipment, and Systems & Software. The Equipment further studied across Cell Processing Equipment and Single-Use Equipment.

Based on Process, the Cell Therapy Technologies Market studied across Cell Preservation, Distribution, and Handling, Cell Processing, and Process Monitoring and Quality Control.

Based on Cell Type, the Cell Therapy Technologies Market studied across Animal Cells and Human Cells. The Human Cells further studied across Differentiated Cells and Stem Cells.

Based on End User, the Cell Therapy Technologies Market studied across Life Science Research Companies and Research Institutes.

Based on Geography, the Cell Therapy Technologies Market studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas region surveyed across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific region surveyed across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa region surveyed across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Company Usability Profiles: The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Therapy Technologies Market including Beckman Coulter, Inc., Becton, Dickinson and Company, Ge Healthcare, Lonza Group, Merck KGaA, Miltenyi Biotec GmbH, Sartorius, Stemcell Technologies, Terumo Bct, Inc., and Thermo Fisher Scientific, Inc..

FPNV Positioning Matrix: The FPNV Positioning Matrix evaluates and categorizes the vendors in the Cell Therapy Technologies Market on the basis of Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Competitive Strategic Window: The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth.

Cumulative Impact of COVID-19: COVID-19 is an incomparable global public health emergency that has affected almost every industry, so for and, the long-term effects projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlaying COVID-19 issues and potential paths forward. The report is delivering insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecast, considering the COVID-19 impact on the market.

The report provides insights on the following pointers: 1. Market Penetration: Provides comprehensive information on the market offered by the key players 2. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets 3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments 4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players 5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments

The report answers questions such as: 1. What is the market size and forecast of the Global Cell Therapy Technologies Market? 2. What are the inhibiting factors and impact of COVID-19 shaping the Global Cell Therapy Technologies Market during the forecast period? 3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Cell Therapy Technologies Market? 4. What is the competitive strategic window for opportunities in the Global Cell Therapy Technologies Market? 5. What are the technology trends and regulatory frameworks in the Global Cell Therapy Technologies Market? 6. What are the modes and strategic moves considered suitable for entering the Global Cell Therapy Technologies Market?

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Animal Stem Cell Therapy Sales Market 2020 Size by Product Analysis, Application, End-Users, Regional Outlook, Competitive Strategies and Forecast to…

New Jersey, United States,- The most recent Animal Stem Cell Therapy Sales Market Research study includes some significant activities of the current market size for the worldwide Animal Stem Cell Therapy Sales market. It presents a point by point analysis dependent on the exhaustive research of the market elements like market size, development situation, potential opportunities, and operation landscape and trend analysis. This report centers around the Animal Stem Cell Therapy Sales business status, presents volume and worth, key market, product type, consumers, regions, and key players.

The COVID-19 pandemic has disrupted lives and is challenging the business landscape globally. Pre and Post COVID-19 market outlook is covered in this report. This is the most recent report, covering the current economic situation after the COVID-19 outbreak.

Key highlights from COVID-19 impact analysis:

Unveiling a brief about the Animal Stem Cell Therapy Sales market competitive scope:

The report includes pivotal details about the manufactured products, and in-depth company profile, remuneration, and other production patterns.

The research study encompasses information pertaining to the market share that every company holds, in tandem with the price pattern graph and the gross margins.

Animal Stem Cell Therapy Sales Market, By Type

Animal Stem Cell Therapy Sales Market, By Application

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A brief overview of the regional landscape:

Reasons To Buy:

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Market Research Intellect provides syndicated and customized research reports to clients from various industries and organizations with the aim of delivering functional expertise. We provide reports for all industries including Energy, Technology, Manufacturing and Construction, Chemicals and Materials, Food and Beverage, and more. These reports deliver an in-depth study of the market with industry analysis, the market value for regions and countries, and trends that are pertinent to the industry.

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Lung cancer mortality reduction linked to improvements in targeted therapies – 2 Minute Medicine

1. In this retrospective cohort study, there was an observed decrease in mortality in non-small-cell lung cancer patients that corresponded with the approval of targeted therapies

2. The improved mortality of small cell lung cancer was not driven by treatment advancement but rather a decrease in the incidence

Evidence Rating Level: 2 (Good)

Study Rundown: Lung cancer is the deadliest cancer in the United States. It can be divided into two histological subtypes: non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). Using the U.S. Surveillance, Epidemiology, and End Results (SEER) database, the authors in this study analyzed mortality trends attributed to the specific histological subtype of lung cancer termed incidence-based mortality. For men and women with NSCLC, incidence and incidence-based mortality decreased, with a greater mortality decrease from 2013-2016 corresponding with an improvement in survival from diagnosis. For SCLC, incidence and incidence-based mortality decreased but with no improvement in survival from diagnosis. Notably, the authors point out that EGFR targeted therapies were approved in 2013 which corresponds to the increase in survival in NSCLC. There should be caution in the interpretation in the studys suggestion that the survival benefit is entirely driven by targeted therapies as there is no direct data on the number of patients treated with EGFR targeted therapies right after 2013. However, the results of these study are generalizable given that it encompassed diverse demographics which showed consistent trends across race and gender subgroups and adequate follow-up data.

Click here to read the study, published today in NEJM

Relevant Reading: Updated statistics of lung and bronchus cancer in United States (2018)

In-Depth [retrospective cohort]: In this retrospective cohort study, lung cancer incidence and lung cancer linked deaths were analyzed in the SEER cancer registry from 2001 to 2016. For NSCLC, in men, the annual incidence decreased by 1.9% from 2001 to 2008, and then by 3.1% from 2008 to 2016. Incidence-based mortality decreased by 3.2% annually from 2006 to 2013 and then decreased by 6.3% from 2013 to 2016. Among women, 2001-2006 incidence did not change significantly, while from 2006-2013 incidence decreased by 1.5% annually. Incidence-based mortality decreased by 2.3% from 2006 to 2014, and then by 5.9% from 2014-2016. 2-year survival improved from 35% in 2001 to 44% in 2014 for women and went from 25% to 35% for men. For SCLC from 2001-2016, in men, the incidence decreased by 3.6%, while incidence-based mortality decreased by 4.3%. For women, the incidence decreased by 2.7% and incidence-based mortality decreased by 3.7%. 2-year survival from 2001 vs. 2016 was 12% and 11% for men and 14% and 17% for women. Taken together, these results indicated that mortality decreases in NSCLC were likely driven by improved survival, and for SCLC, it was mainly driven by decreased incidence.

Image: PD

2020 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

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Stem Cell Alopecia Treatment Market 2020 analysis with Key Players, Applications, Future Trends and Forecasts by 2027 – Chelanpress

Competitive Landscape of the Stem Cell Alopecia Treatment Market:

The Market for the Stem Cell Alopecia Treatment Market industry is extremely competitive, with several major players and small scale industries. Adoption of advanced technology and development in production are expected to play a vital role in the growth of the industry. The report also covers their mergers and acquisitions, collaborations, joint ventures, partnerships, product launches, and agreements undertaken in order to gain a substantial market size and a global position.

Regional Analysis of Global Stem Cell Alopecia Treatment Market:

The report offers a comprehensive breakdown of the regional analysis of the market and subsequent country-wise analysis. The regional analysis of the market comprises of production volume information, consumption volume and patterns, revenue, and growth rate for the forecast period of 2020-2027. According to the regional analysis, the market is primarily spread over key geographical regions such as North America (U.S.A, Canada, and Mexico), Europe (Germany, Italy, Spain, UK, and Rest of EU), Asia Pacific (India, Japan, China, South Korea, and Rest of APAC), Latin America (Brazil, Chile, Peru, Argentina, and Rest of Latin America), and Middle East & Africa (Saudi Arabia, South Africa, and Rest of MEA).

Highlights of the TOC of the Global Stem Cell Alopecia Treatment Market Report:

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The report offers a complete company profiling of leading players competing in the Global Stem Cell Alopecia Treatment Market with a high focus on the share, gross margin, net profit, sales, product portfolio, new applications, recent developments, and several other factors. It also throws light on the vendor landscape to help players become aware of future competitive changes in the Global Stem Cell Alopecia Treatment Market.

Our research Data provides answers to the following key questions:

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Stem Cell Alopecia Treatment Market 2020 analysis with Key Players, Applications, Future Trends and Forecasts by 2027 - Chelanpress

Akari Therapeutics Announces Successful End-of-Phase II Meeting With FDA to Initiate Pivotal Phase III Study for Treatment of Bullous Pemphigoid With…

NEW YORK and LONDON, Aug. 12, 2020 (GLOBE NEWSWIRE) --Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces a successful End of Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding Akaris proposed pivotal Phase III program for the treatment of BP.

The FDA has agreed to a two-part pivotal trial with Part A and Part B having the same structure, duration, endpoints and target population of moderate and severe BP patients.

In the Phase III study, patients will be randomized to receive either nomacopan plus oral corticosteroids (OCS) or placebo plus OCS. Following an initial stabilization phase, the steroids will be tapered according to disease response to a minimal level of OCS (< 0.1mg/kg/d prednisone or equivalent) which is considered safe. If disease response is rapid, as was seen in the nomacopan Phase II study in patients with BP, OCS could be tapered to the minimal level within six weeks. The goal of conventional OCS tapering is to achieve minimal therapy (prednisone <0.1mg/kg/day) within four to six months after initiation of treatment1. Patients will only have their OCS tapered if their disease continues to respond to treatment as the OCS dose is decreased.

Once patients are on minimal OCS plus either nomacopan or placebo, the primary endpoint will be achieved by those patients with complete disease remission for eight weeks or longer. The duration of the study is six months after which patients may be eligible to enter a separate one-year long-term safety study to provide at least six months of additional safety data.

Part A of the study is the same design as Part B but smaller and with the objective of comparing the Companys target dose (comparable to dosing used in the Companys hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) and paroxysmal nocturnal hemoglobinuria (PNH) Phase III programs) with a lower dose of nomacopan and with placebo. Following Part A and discussion with the FDA, Part B will be conducted at the same trial sites using the optimal dose from Part A.

Clive Richardson, Chief Executive Officer of Akari Therapeutics, said, Following our positive Phase II study, we are very pleased that the FDA has agreed with the pivotal study design and provided a clear pathway to a potential approval for nomacopan in patients with BP. Success in this study would also open up a range of other dermatological conditions with related pathology.

Russell P. Hall, M.D., Professor of Dermatology, Duke University School of Medicine, who attended Akaris EOP2 meeting, said, These proposed studies are expected to provide the critical data needed to assess the efficacy of nomacopan in providing rapid control of the inflammation in the skin of patients with bullous pemphigoid and minimize the need for high dose systemic corticosteroids in this very vulnerable patient population.

1Feliciani et al (2015)

Background on Bullous Pemphigoid (BP)

BP is a severe orphan autoimmune inflammatory blistering skin disease with no approved treatments in the U.S. and Europe. This chronic disease may last several years in the absence of treatment and has a tendency to relapse. BP is most common in the elderly and is primarily treated with steroids and immunosuppressants for six months or more which bring with them deleterious side effects and an approximately three-fold increase in mortality in the BP treated population. The prevalence of BP is estimated to be over 100,000 patients in U.S. and Europe.

In BP patients there is evidence that both terminal complement activation (via complement component C5) and the lipid mediator leukotriene B4 (LTB4) have a central role in driving the disease. Ex vivo data in BP patients, published in the August 2019 edition of JCI Insight [LINK], showed a pronounced accumulation of LTB4 and C5 and its activation products in the inflamed skin of BP patients. This underlies the rationale for treatment with nomacopan which is a unique bifunctional inhibitor of both C5 and LTB4 and a range of downstream cytokines. In addition to BP, the Company believes this unique mode of action underpins the activity of nomacopan across the Companys other target conditions TMA-HSCT, COVID pneumonia and ophthalmology.

AboutAkari Therapeutics Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity.

Cautionary Note Regarding Forward-Looking Statements Certain statements in this press release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. You should not place undue reliance upon the Companys forward looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected; risks associated with the impact of the outbreak of coronavirus; risks associated with the SEC investigation; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Investor Contact:

Peter Vozzo Westwicke +1 (443) 213-0505 peter.vozzo@westwicke.com

Media Contact:

Sukaina Virji/Lizzie Seeley Consilium Strategic Communications +44 (0)20 3709 5700 Akari@consilium-comms.com

See the article here:
Akari Therapeutics Announces Successful End-of-Phase II Meeting With FDA to Initiate Pivotal Phase III Study for Treatment of Bullous Pemphigoid With...