Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Awa – PharmiWeb.com

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK CellsNK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact:

Name:Dani Frank

Email:celularity@factorypr.com

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Awa - PharmiWeb.com

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 – PRNewswire

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK CellsNK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact:

Name:Dani Frank

Email:[emailprotected]

SOURCE Celularity

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 - PRNewswire

Progenitor Cell-Based Market 2020-2026 is Slated to Witness Tremendous Growth || Leading Players BAXTER INTERNATIONAL INC, Boehringer Ingelheim…

In Progenitor Cell-Based Market report, a systematic investment analysis has been performed which forecasts impending opportunities for the market players. The statistical and numerical data that has been included in this market report is represented with the tables, graphs and charts which eases the understanding of facts and figures. A proficient data and excellent forecasting techniques used in this report are synonymous with accurateness and correctness. Progenitor Cell-Based Market report is a painstaking analysis of existing scenario of the market which covers several market dynamics. The market study of this global Progenitor Cell-Based Market business report takes into consideration market attractiveness analysis where each segment is benchmarked based on its market size, growth rate & general attractiveness.

Get Exclusive Sample Report + All Related Graphs & Charts Here@https://www.databridgemarketresearch.com/request-a-sample?dbmr=global-progenitor-cell-based-market

Global progenitor cell-based marketis estimated to register a substantial CAGR in the forecast period of 2019 to 2026. The imminent market report contains data for historic year 2017, the base year of calculation is 2018 and the forecast period is 2019 to 2026. The growth of the market can be attributed to the rising geriatric population.

Some of the major companies functioning in globalprogenitor cell-based marketareF. Hoffmann-La Roche Ltd, Pfizer Inc., Merck & Co., Inc., Abbott, Vericel, Novartis AG, Alcon, GlaxoSmithKline plc, BAXTER INTERNATIONAL INC, Boehringer Ingelheim International GmbH, Amgen Inc., Bristol-Myers Squibb Company, Nuvasive, Inc., Organogenesis, Inc., Nu-Tech International, MiMedx, Stability Biologic., Takara Bio Inc., Caladrius, Biosciences, Inc., U.S. Stem Cell, Inc., Cesca Therapeutics and Osiris Therapeutics, Inc among others

Table of Contents is Available[emailprotected]https://www.databridgemarketresearch.com/toc?dbmr=global-progenitor-cell-based-market

Market Definition: Global Progenitor Cell-Based Market

Progenitor cellare the kind of stem cell which are located in bone marrow and also called as hematopoietic. These cells give rise to the different cell lines. The progenitor cells can divide and stem cells can replicate indefinitely. Progenitor cells are used in various neurological disorders such as Parkinson disease and Huntington disease.

Prevalence of Parkinsons disease (PD) increases with increasing age but an estimated four percent of people with Parkinsons disease are diagnosed before age 50, more than 10 million people worldwide are living with Parkinsons disease, and other neurological diseases.

Segmentation:Global Progenitor Cell-Based Market

Progenitor Cell-Based Market : By Type

Progenitor Cell-Based Market : By Therapeutic Application

Progenitor Cell-Based Market : By Cell Source

Progenitor Cell-Based Market : By End User

Progenitor Cell-Based Market : By Geography

Key Developments in the Progenitor Cell-Based Market:

Progenitor Cell-Based Market Drivers

Progenitor Cell-Based Market Restraints

Opportunities in the Progenitor Cell-Based Market Report :

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Progenitor Cell-Based Market 2020-2026 is Slated to Witness Tremendous Growth || Leading Players BAXTER INTERNATIONAL INC, Boehringer Ingelheim...

Global Myelofibrosis Treatment Market Overview By Growing Demands, Trends And Business Opportunities 2020 To 2029 – Owned

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Myelofibrosis Treatment market.

Trusted Business Insights presents an updated and Latest Study on Myelofibrosis Treatment Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Myelofibrosis Treatment market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Myelofibrosis Treatment Market by Diagnosis Type (Gene Mutation Analysis, Bone Marrow biopsy, Imaging Test, and Blood Tests), by Treatment Type (Chemotherapy, Blood Transfusions, Stem Cell Transplant, Splenectomy, Radiation Therapy, and Others), by Drug Type (Hydroxyurea, Immunomodulators, JAK Inhibitor, and Others), and by End-User (Hospitals, Clinics, and Bone Marrow Transplant Centers)-Global Industry Analytics, COVID-19 Business Impact, and Trends, 2020 2029

Abstract

The report covers forecast and analysis for the myelofibrosis treatment market on the global and regional level. The study provides historic data for 2016 and 2017 along with a forecast from 2018 to 2024 based on revenue (USD Million). The study includes drivers and restraints for the myelofibrosis treatment market along with the impact they have on the demand over the forecast period. Additionally, the report includes the study of opportunities available in the myelofibrosis treatment market on a global level.

In order to give the users of this report a comprehensive view of the myelofibrosis treatment market, we have included competitive landscape and analysis of Porters Five Forces Model for the market. The study encompasses a market attractiveness analysis, where diagnosis type, treatment type, drug type, and end users segments are benchmarked based on their market size, growth rate, and general attractiveness.

The report provides company market share analysis in order to give a broader overview of the key players in the market. In addition, the report also covers key strategic developments of the market including merger and acquisitions, new drug launch, drug pipeline, agreements, partnerships, collaborations & joint ventures, R&D, and regional expansion of major participants involved in the market on the global and regional basis. Moreover, the study covers price trends analysis, the product portfolio of various companies according to the region.

The study provides a decisive view of the myelofibrosis treatment market by segmenting the market into diagnosis type, treatment type, drug type, end users, and regions. All the segments have been analyzed based on present and the future trends and the market is estimated from 2018 to 2024. Based on diagnosis type, the market is segmented into gene mutation analysis, bone marrow biopsy, an imaging test, and blood tests. Based on treatment type, the market is segmented into chemotherapy, blood transfusions, stem cell transplant, splenectomy, radiation therapy, and others. Based on drug type, the market is segmented into hydroxyurea, immunomodulators, JAK inhibitor, and others. Based on end users, the market is segmented into hospitals, clinics, and bone marrow transplant centers. The regional segmentation includes the current and forecast demand for North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa with its further categorization into major countries including the U.S., Canada, Germany, the UK, France, Spain, Italy, China, Japan, India, Brazil, and Mexico. This segmentation includes demand for myelofibrosis treatment based on individual diagnosis type, treatment type, drug type, and end users in all the regions and countries.

The report also includes detailed profiles of end players such as Eli Lilly and Company, Gilead Sciences Inc., F. Hoffmann-La Roche Ltd., Incyte Corporation, Merck & Co., Bristol-Myers Squibb Company, Novartis AG, Amgen Inc., and Celgene Corporation, among others.

The report segments the global myelofibrosis treatment market as follows:

Global Myelofibrosis Treatment Market: Diagnosis Type Segment Analysis

Gene Mutation Analysis Bone Marrow Biopsy Imaging Test Blood Test

Global Myelofibrosis Treatment Market: Treatment Type Segment Analysis

Chemotherapy Blood Transfusions Stem Cell Transplant Splenectomy Radiation Therapy Others

Global Myelofibrosis Treatment Market: Drug Type Segment Analysis

Hydroxyurea Immunomodulators JAK Inhibitors Others

Global Myelofibrosis Treatment Market: End-User Segment Analysis

Hospitals Clinics Bone Marrow Transplant Centers

Global Myelofibrosis Treatment Market: Regional Segment Analysis

North America

The U.S.

Europe

UK France Germany

Asia Pacific

China Japan India

Latin America

Brazil

Middle East and Africa

Quick Read Table of Contents of this Report @ Myelofibrosis Treatment Market by Diagnosis Type (Gene Mutation Analysis, Bone Marrow biopsy, Imaging Test, and Blood Tests), by Treatment Type (Chemotherapy, Blood Transfusions, Stem Cell Transplant, Splenectomy, Radiation Therapy, and Others), by Drug Type (Hydroxyurea, Immunomodulators, JAK Inhibitor, and Others), and by End-User (Hospitals, Clinics, and Bone Marrow Transplant Centers)-Global Industry Analytics, COVID-19 Business Impact, and Trends, 2020 2029

Trusted Business Insights Shelly Arnold Media & Marketing Executive Email Me For Any Clarifications Connect on LinkedIn Click to follow Trusted Business Insights LinkedIn for Market Data and Updates. US: +1 646 568 9797 UK: +44 330 808 0580

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Global Myelofibrosis Treatment Market Overview By Growing Demands, Trends And Business Opportunities 2020 To 2029 - Owned

Orphan Drug Designation granted to tinostamustine in EU for very rare form of leukaemia – Pharmafield

Mundipharma has announced that the European Commission (EC) has now adopted the European Medicines Agency (EMA) Committee for Orphan Medicinal Products recommendation to grant Orphan Drug Designation to tinostamustine, an alkylating histone-deacetylase inhibiting molecule, for the treatment of T-cell prolymphocytic leukaemia (T-PLL).3

The EMA considers Orphan Drug Designation (ODD) status for medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than five per 10,000 people in the EU.4

T-PLL is an extremely rare and typically aggressive leukaemia.5,6 It affects approximately 2% of all patients with mature lymphocytic leukaemias1 and affects older adults with a median age at diagnosis of 61 years. It is more common in men than in women.2 T-PLL is characterised by the out-of-control growth of mature T-cells (T-lymphocytes). T-cells are a type of white blood cell that protects the body from infections.2 Due to its rarity, T-PLL can be misdiagnosed, resulting in poor patient outcomes.5 The condition is life-limiting and chronically debilitating, with fewer than 5% of patients surviving to five years from diagnosis.7 T-PLL generally progresses rapidly and does not respond well to standard multi-agent chemotherapy, with relapses being a common occurrence.5,6

Brian Sheehan, Chief Scientific Officer, Mundipharma Research added: Orphan drug designation is an important milestone in the development of tinostamustine, which is currently in early phase clinical trials. We are proud of our commitment to helping patients with rare and difficult-to-treat cancers, such as T-PLL, where therapeutic options are so limited and patients have a clear need for new therapies.

The EC decision adopting the EMA opinion follows that of the FDA, which granted tinostamustine ODD status for the treatment of T-PLL in March 2019.

Tinostamustine, is an alkylating histone-deacetylase inhibiting molecule in early phase clinical development for a range of rare and difficult-to-treat blood cancers and advanced solid tumours.Preclinical studies have shown that tinostamustine has the potential to improve access to the DNA strands within cancer cells, break them and counteract damage repair.8-11 The preclinical data also suggest that these complementary and simultaneous modes of action have the potential to overcome resistance towards some other cancer treatments.8-11

References

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Orphan Drug Designation granted to tinostamustine in EU for very rare form of leukaemia - Pharmafield

Humanigen to Present at the BTIG Virtual Biotechnology Conference 2020 – Business Wire

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc., (HGEN) (Humanigen), announced today that Cameron Durrant, MD, MBA, Chief Executive Officer and Dale Chappell, MD, MBA, Chief Scientific Officer of Humanigen will present a company overview and business update at the BTIG Virtual Biotechnology Conference 2020 on Tuesday, August 11th, 2020 at 2:00 pm Eastern Time. The conference is being held in a virtual format.

A live webcast of the event can be accessed at https://www.humanigen.com/investor-materials.

An archived replay of the event will be available on the Company website for 30 days following the event.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The companys immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit http://www.humanigen.com.

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Humanigen to Present at the BTIG Virtual Biotechnology Conference 2020 - Business Wire

NICE Amends Guidance on Haematopoietic Stem Cell Transplantation During the Pandemic – Medscape

The National Institute for Health and Care Excellence (NICE) has amended its recommendations on advice and testing for COVID-19 among patients undergoing haematopoietic stem cell transplantation and donors.

As of 29 July 2020,changeshave been made to the following sections:

Advice for patients to limit the number of family members who attend appointments (recommendation 1.3) and explaining measures to limit infection risk (new recommendation 1.4).

Advice for patients on minimising risk of respiratory infections before transplantation (recommendation 3.1).

Testing for respiratory viruses before transplantation (recommendation 3.2).

Additional investigations for patients who test positive for or are suspected of having COVID-19 (new recommendation 3.7).

Tests for donors and actions if the results are positive (new recommendation 4.5 and recommendation 4.6); these recommendations now apply to related donors, not just sibling donors (recommendation 4.1).

Risk assessment for donors who test positive (recommendation 4.8) and a reduction in the delay in providing blood products after a positive test (recommendation 4.10).

Advice for patients post-transplant (recommendation 5.2).

Assessing when staff who test positive or have symptoms can return to work (recommendation 6.2).

Routine screening for staff (new recommendation 6.3).

Prioritising treatment (table 1).

Risk assessments for ambulatory transplant pathways (new recommendation 8.3).

What to do when a centre is temproarily closed (recommendation 8.6).

Assessing risk in storing cells from a donor with COVID-19 (recommendation 8.9) and the viability of cryopreserved stem cells (new recommendation 8.10).

Using granulocyte-colony stimulating factor to minimise the use of chemotherapy priming.

NICE has also removed recommendations (originally numbered 3.3, 3.4 and 7.3) that advised deferring most autologous and allogeneic haematopoietic stem cell transplants, and deferring transplants if further treatment or immunosuppression would put them at more risk from COVID-19 in the community. This is to reflect changes in the risk of infection and the capacity in services.

This article originally appeared on Univadis, part of the Medscape Professional Network.

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NICE Amends Guidance on Haematopoietic Stem Cell Transplantation During the Pandemic - Medscape

Cure for Covid-19 may never materialise says WHO, but there is still hope – The National

In March, when Covid-19 was declared a pandemic by the World Health Organisation, few people imagined that the outbreak would stretch into the summer. Many political leaders were hopeful that temporary lockdowns across the world would end the crisis and that life could soon go back to normal. Yet, in the absence of a vaccine, precautions such as wearing masks, working from home and physical distancing have become the new norm.

On Monday, WHO director general Tedros Adhanom Ghebreyesus warned that a solution may, in fact, never be found. When it comes to the coronavirus, he said: there is no silver bullet at the moment and there might never be, despite the worlds best efforts to find a cure or a treatment for Covid-19.

It is the WHOs responsibility to inject a dose of reality into global health policies and to manage expectations. Vaccines can take years to develop and test until they are safe for the public to use, but this does not mean that the coronavirus crisis cannot be controlled until that happens.

Research into treatments and cures are already well under way. Across the world there are 23 vaccines being tested on humans, but only three of them have entered the last phase. The UAE, having understood the importance of research into the coronavirus early on, invested in it heavily. It is the first country in the world that began phase III clinical trials and thousands of people volunteered to take the jab here in Abu Dhabi.

While the public awaits a vaccine, there is hopeful news: treatments to alleviate the suffering of patients and hasten their recovery have shown promising results.

In May, Abu Dhabi Stem Cell Centre said it had developed a new type of stem cell therapy that could help shorten recovery time for Covid-19 patients. This treatment is free for those suffering from the disease in the UAE. In the US, meanwhile, the antiviral drug Remdesivir has managed to improve the health of patients who are severely affected by Covid-19.

It is the WHOs responsibility to inject a dose of reality into global health policies and manage expectations

While scientists are at work to find a vaccine or a treatment, the knowledge they have gathered so far about Covid-19 has equipped governments and the public to fight the pandemic more efficiently. Directives on wearing masks, physical distancing and actively sanitising are among measures now understood and adopted widely. Lockdowns, despite their negative economic impact, have slowed the spread of the virus, especially when cases peaked.

As nations gradually reopen, governments are more aware of the tools needed to prevent a public health catastrophe. Mass testing and equipping hospitals with life-saving personal protective equipment and ventilators are a must. In the UAE, enforcing such measures has allowed the country to attain a 90 per cent coronavirus cure rate, as 5 million tests have been carried out nationwide.

While the coronavirus is unlikely to be eradicated in the near future, the world has learnt to better control outbreaks. A time will hopefully come when the pandemic is behind us. Till then, however, we must use and perfect the tools and knowledge gathered in the past eight months to continue fighting the coronavirus.

Updated: August 4, 2020 09:03 PM

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Cure for Covid-19 may never materialise says WHO, but there is still hope - The National

Strathmore man with MS calls for more Canadian treatment alternatives – CTV Toronto

CALGARY -- Hes just 49 years old and already his mobility is mostly confined to his right hand. If Chad Tashlikowich can halt the progression of his primary-progressive multiple sclerosis (MS) there, hell consider it a victory.

In 2014 Tashlikowich crowd-funded an $80,000 stem cell treatment in Russia hoping to keep him out of an electric wheel chair. That therapy was unsuccessful.

It really hasnt changed the trajectory at all, he says. Despite the risks and expense, his health didnt improve. Its really poor. Its kind of gone downhill really ever since. I dont think the stem cells did a lot,

Now he wants to try a drug treatment ocrevus recommended to him by an American physician, Dr. Aaron Boster, who specializes in MS, a disease that attacks the central nervous system.

The problem is, in Canada the drug is not approved for use on patients with Tashlikowichs form of the disease.

You have a mechanic for your car. And if he doesnt do a good job you get another one. You cant do that with a neurologist, Tashlikowich says.

Dr. Luann Metz is a neurology professor at the University of Calgary. She says she understands how MS patients can see some of these therapies as worth the expense and the risk, given their dire prognoses. But Metz cautions that not all foreign treatment is what its advertised to be, and even when it is, there are medical reasons why guidelines are what they are in Canada.

The problem is, that when people go outside the country for unapproved therapies, they are often not in regulated situations, says Dr. Metz, adding that stem cell therapy in particular has shown to sometimes worsen outcomes in primary-progressive MS patients.

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Strathmore man with MS calls for more Canadian treatment alternatives - CTV Toronto

Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments – Cambridge Independent

Avacta has extended its collaboration and license agreement with Daewoong Pharmaceutical Co and their South Korean joint venture AffyXell Therapeutics.

They will develop stem cell treatments incorporating Avactas neutralising Affimer therapy for the treatment of seriously ill patients with Covid-19 and prepare for the rapid development of similar therapies for future global pandemics.

Stem cell therapies offer one potential route to repairing lung tissue damage caused by the immune systems over-reaction to respiratory diseases such as Covid-19.

AffyXell Therapeutics, a next-generation cell and gene therapy joint venture between Whittlesford-based Avacta and Daewoong, is developing mesenchymal stem cell (MSC) treatments engineered to produce Affimer therapies in the patient at the site of action.

The partnership has been extended to include Affimer molecules that target viruses, such as coronaviruses, to develop therapies that repair lung damage, while also producing neutralising Affimer molecules to prevent the progression of the disease.

Under the expanded partnership, AffyXell will engineer mesenchymal stem cells to express SARS-CoV-2 neutralising Affimer molecules to develop treatments for seriously ill Covid-19 patients. It will also prepare for rapid development of next-generation stem cell therapies for future infectious respiratory disease outbreaks.

Avacta CEO Dr Alastair Smith said: I am very pleased to have extended our collaboration and license agreement with Daewoong Pharmaceutical to include the SARS-CoV-2 neutralising Affimer molecules for the treatment of Covid-19 and to create the potential to respond very rapidly in future to global virus threats.

AffyXell will address the need over the coming years for advanced stem cell therapies to treat lung damage caused by cytokine release syndrome suffered by Covid-19 patients and, at the same time, help prevent disease progression in these patients through the action of a neutralising Affimer therapy.

More broadly, one of the key areas of unmet clinical need that AffyXell can address with its next-generation mesenchymal stem cell therapies is acute pulmonary diseases such as COPD and acute respiratory distress syndrome. We, and our partners in South Korea, are very excited by the potential to develop life improving treatments for patients with these serious respiratory diseases as well as Covid-19.

Seng-ho Jeon, CEO of Daewoong Pharmaceutical and AffyXell Therapeutics, said:

It is very encouraging that AffyXell now has the opportunity to expand the application of its next-generation stem cell platform technology to target viruses. The SARS-CoV-2 neutralising Affimer to be developed in combination with AffyXells cell and gene technology is expected to be an innovative solution for COVID-19 patients suffering cytokine release syndrome.

Daewoong has been also conducting several research programs and clinical trial for Covid19. As the Covid-19 crisis has caused great difficulties worldwide, we will continue to focus our efforts to develop a novel therapeutic agent for Covid-19.

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Avacta extends partnership with Daewoong Pharmaceutical and AffyXell Therapeutics for Covid-19 stem cell treatments - Cambridge Independent