First patient successfully dosed in cardiomyopathy study
STRATFORD-UPON-AVON, UK I July, 6 2019 I Celixir, a privately-owned company discovering and developing life-saving advanced therapies, announces an update to its ongoing clinical programme with lead therapeutic candidate CLXR-001. The first patient was successfully dosed in the Company’s Heartcel clinical trial of its novel iMP cells in patients with cardiomyopathy on March 16, 2020 and is now in the follow up stage. CLXR-001 is a novel formulation that allows for rapid point-of-care use of Celixir’s novel allogeneic (off-the-shelf) iMP cells without the requirement for a cell culture laboratory.
In consultation with the Medicines and Healthcare products Regulatory Agency (MHRA) and given the suspension of research trials due to the Covid-19 pandemic, Celixir has made the decision to suspend the current Heartcel clinical trial and replace the current clinical trial application (CTA) with a revised protocol. Recruitment is scheduled to recommence under a new CTA in Q3 2020 ‒ subject to lifting of Covid-19 restrictions ‒ with the study expected to complete in 2021.
Celixir continues to work closely with guidance from the MHRA and the Health Research Authority (HRA) and NHS Research Ethics Committee (REC), all of which reviewed the regulatory dossier prior to granting approval in 2019.
Professor Stephen Westaby, Celixir’s Chief Cardiac Medical Advisor, said: “A 2012 investigator-led trial run by an academic team in Greece importantly showed no adverse effects and all the patients are still doing well several years later. This was a small study but the outcomes were remarkable. There was a significant reduction of scar tissue in the damaged heart muscle, which conveyed a reduced likelihood of developing heart failure. Our larger, formal clinical trial aims to further investigate this important finding with a new off-the-shelf formulation that can be used quickly, without the need for cell culture. We believe that this treatment has enormous potential to improve the lives of the many millions of patients with cardiomyopathy.”
Professor Sir Martin Evans, Celixir’s Chief Scientific Officer, added: “Heart failure remains a life threatening condition and innovative new treatments are desperately needed. We are pioneering a cellular therapy aimed at progressing the heart regeneration field and which, if the trials prove effective, will itself provide a significant benefit towards recovery. This trial highlights our small company’s important contribution to the field including a novel cell therapy with an off-the-shelf product formulation, GMP manufacturing and UK-approved clinical trial.”
About Celixir
Celixir is a privately owned UK biotechnology company that discovers and develops life-saving and life-altering advanced therapies for patients with the greatest medical need. Celixir, founded in 2009, is made up of a world class team of scientists and biopharmaceutical executives, led by Nobel Laureate Professor Sir Martin Evans and former Roche Global Head of Emerging Technologies, Ajan Reginald. Celixir’s unique platform technology allows it to adopt an ‘off-the-shelf’ approach to deliver cell therapies to patients. The Company has a partnership with Daiichi Sankyo in which the Japanese pharmaceutical company undertakes all development, regulatory and commercial activities for Celixir’s immunomodulatory progenitor cells in Japan. Celixir retains worldwide rights outside of Japan and global manufacturing responsibilities.
SOURCE: Celixir
Post Views: 66
First patient successfully dosed in cardiomyopathy study
STRATFORD-UPON-AVON, UK I July, 6 2019 I Celixir, a privately-owned company discovering and developing life-saving advanced therapies, announces an update to its ongoing clinical programme with lead therapeutic candidate CLXR-001. The first patient was successfully dosed in the Company’s Heartcel clinical trial of its novel iMP cells in patients with cardiomyopathy on March 16, 2020 and is now in the follow up stage. CLXR-001 is a novel formulation that allows for rapid point-of-care use of Celixir’s novel allogeneic (off-the-shelf) iMP cells without the requirement for a cell culture laboratory.
In consultation with the Medicines and Healthcare products Regulatory Agency (MHRA) and given the suspension of research trials due to the Covid-19 pandemic, Celixir has made the decision to suspend the current Heartcel clinical trial and replace the current clinical trial application (CTA) with a revised protocol. Recruitment is scheduled to recommence under a new CTA in Q3 2020 ‒ subject to lifting of Covid-19 restrictions ‒ with the study expected to complete in 2021.
Celixir continues to work closely with guidance from the MHRA and the Health Research Authority (HRA) and NHS Research Ethics Committee (REC), all of which reviewed the regulatory dossier prior to granting approval in 2019.
Professor Stephen Westaby, Celixir’s Chief Cardiac Medical Advisor, said: “A 2012 investigator-led trial run by an academic team in Greece importantly showed no adverse effects and all the patients are still doing well several years later. This was a small study but the outcomes were remarkable. There was a significant reduction of scar tissue in the damaged heart muscle, which conveyed a reduced likelihood of developing heart failure. Our larger, formal clinical trial aims to further investigate this important finding with a new off-the-shelf formulation that can be used quickly, without the need for cell culture. We believe that this treatment has enormous potential to improve the lives of the many millions of patients with cardiomyopathy.”
Professor Sir Martin Evans, Celixir’s Chief Scientific Officer, added: “Heart failure remains a life threatening condition and innovative new treatments are desperately needed. We are pioneering a cellular therapy aimed at progressing the heart regeneration field and which, if the trials prove effective, will itself provide a significant benefit towards recovery. This trial highlights our small company’s important contribution to the field including a novel cell therapy with an off-the-shelf product formulation, GMP manufacturing and UK-approved clinical trial.”
About Celixir
Celixir is a privately owned UK biotechnology company that discovers and develops life-saving and life-altering advanced therapies for patients with the greatest medical need. Celixir, founded in 2009, is made up of a world class team of scientists and biopharmaceutical executives, led by Nobel Laureate Professor Sir Martin Evans and former Roche Global Head of Emerging Technologies, Ajan Reginald. Celixir’s unique platform technology allows it to adopt an ‘off-the-shelf’ approach to deliver cell therapies to patients. The Company has a partnership with Daiichi Sankyo in which the Japanese pharmaceutical company undertakes all development, regulatory and commercial activities for Celixir’s immunomodulatory progenitor cells in Japan. Celixir retains worldwide rights outside of Japan and global manufacturing responsibilities.
SOURCE: Celixir
Post Views: 66
