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ReNeuron Spies SPA and RMAT For Stem Cell Stroke Therapy

 
• By Alexandra Shimmings

UK cell therapeutics firm ReNeuron has released its late-stage development strategy for its novel stem cell therapy for stroke disability, CTX.

ReNeuron Group PLC hopes to start a pivotal study of its stem cell therapy CTX for stroke disability in early 2018 following an End of Phase II meeting with the US FDA where it was advised to seek an SPA for the trial and apply for Regenerative Medicine Advanced Therapy (RMAT) designation for the product.

The benefits of RMAT designation are similar to those of Breakthrough Therapy designation, and include increased interactions with the FDA during development and eligibility for priority review and accelerated marketing...

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