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