RENEURON IN TALKS WITH FDA TO BEGIN TRIAL OF STROKE THERAPY

ReNeuron has announced an update on the status of its recently filed investigational new drug (IND) application to begin a Phase I clinical study of its ReN001 stem cell therapy for stroke.

The company announced last week that the FDA had placed the proposed clinical study of ReN001 on hold. A conference call with the FDA to discuss the application has subsequently taken place, during which the FDA outlined its questions and requests for further information regarding the IND application.

The points raised during the teleconference were largely expected and are readily addressable, according to ReNeuron. Indeed, the company believes that the other preclinical studies currently under way may answer the main points raised by the FDA. No substantial issues were raised during the call that had not been covered in previous dialogue with the FDA.

"We will be continuing our dialogue with the FDA as we work towards providing the additional information required," Michael Hunt, CEO of ReNeuron, said. "On this basis, we are confident that approval to commence human clinical studies with ReN001 will be granted."

In addition to its stroke program, ReNeuron is developing stem cell therapies for Huntington's disease, Parkinson's disease, Type 1 diabetes and diseases of the retina.