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CellProthera Nears Phase III Trial for Heart Attack Cell Therapy

NextEdge Admin

31 Aug 2024

1 min 46 sec

CellProthera has reported a successful pre-investigational new drug (IND) meeting with the US FDA, marking progress toward a pivotal Phase III trial for its cell therapy targeting myocardial infarction. The France-based company announced that the FDA is aligned with its trial design, which will include a two-year follow-up period. The trial, set to be an open-label, randomized study, will enroll approximately 300 or more patients and feature a composite primary effectiveness endpoint aimed at evaluating the therapy's ability to prevent subsequent heart diseases.

During a press conference in London, CellProthera's CEO, Matthieu de Kalbermatten, revealed plans to seek Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, though no specific timeline was provided. The RMAT designation aims to expedite the development and review of regenerative therapies for serious conditions, allowing the use of surrogate endpoints to potentially accelerate approval.

CellProthera has already completed a Phase II trial of its one-time cell therapy product, ProtheraCytes, which included a six-month follow-up. The company is now moving closer to advancing its innovative treatment through the final stages of clinical development.