Celixir announces US FDA approval of the IND application for cell therapy Heartcel
Celixir announces US FDA approval of the IND
application for cell therapy Heartcel
- FDA IND and UK MHRA CTA approval both achieved
in H1 2018
- Potentially pivotal heart failure trial of up to 250 patients in the UK and US
Stratford-upon-Avon, UK, 08 June 2018 – Celixir, a privately owned company
discovering and developing life-saving advanced therapies, announces that the
US Food and Drug Administration (FDA) has approved its Investigational New Drug
application (IND) for Heartcel its immuno-modulatory progenitor (iMP) cell
therapy for the treatment of adult heart failure.
Celixir
announced in January the approval of a clinical trial application (CTA) from
the UK’s Medicines and Healthcare products Regulatory Agency to initiate a
potentially pivotal Phase II b human clinical trial with Heartcel The
international trial will recruit up to 250 patients and the IND approval allows
expansion to US clinical trial sites.
Ajan
Reginald, Chief Executive Officer of Celixir, commented: “The FDA approval of our IND is a significant
regulatory milestone, which follows UK clinical trial approval in January.
Celixir is now well positioned to conduct potentially pivotal trials with
Heartcel™ in Europe and the US.”
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.
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.
About Heartcel
Heartcel is an allogeneic celixir cell therapy containing off-the-shelf immunomodulatory progenitor (iMP) cells engineered to regenerate the heart. Imps are administered during coronary artery bypass graft (CABG) surgery by direct injection around the cardiac scar that is to be regenerated. iMP cells have been designated an Advanced Therapeutic Medicinal Product (ATMP) by the European Medicines Agency.
Heartcel is an allogeneic celixir cell therapy containing off-the-shelf immunomodulatory progenitor (iMP) cells engineered to regenerate the heart. Imps are administered during coronary artery bypass graft (CABG) surgery by direct injection around the cardiac scar that is to be regenerated. iMP cells have been designated an Advanced Therapeutic Medicinal Product (ATMP) by the European Medicines Agency.
EU
Phase II trials were successfully completed with results presented in 2016 at
the congresses of the European Society of Cardiovascular and Endovascular
Surgery and the European Society of Gene and Cell Therapy. All primary and
secondary endpoints were met: 100% major adverse cardiac event (MACE) free
survival; 30% improvement in heart function; 40% reduction in scar size; and
50% improvements in quality of life. In 2017, four-year follow-up analyses
found the MACE-free survival rate remains at 100%. Potentially pivotal trials
are approved to begin following US IND and UK CTA approvals.
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