8 June 2018
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 HeartcelTM, 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 IIb human clinical trial with HeartcelTM. The international trial will recruit up to 250 patients and the IND approval allows expansion to US clinical trial sites.
“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.”
Ajan ReginaldChief Executive Officer of Celixir
For more information, please contact:
Ajan Reginald, CEO
+44 1789 269 838
Consilium Strategic Communications
Mary Jane Elliott / Ivar Milligan / Sukaina Virji
+44 (0)20 3709 5700
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.
Heartcel is an allogeneic 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.