Drug Development

ReNeuron’s stem cell treatment fails a small stroke study, but the biotech says it’s ready for pivotal

ReNeuron’s mid-stage stem cell study on stroke disability failed to hit a modest primary endpoint. But after stretching and twisting to reach what it was looking for, the biotech cited a few different patient successes and called it all distinctly positive.

Out of only 21 patients being tested, researchers had hoped to see 2 of them achieve a significant increase in a grasping and lifting test three months after they were treated. They didn’t get it. They did get three hits, but only after extending their observation to three, six and 12 months. And 15 of 21 patients had what they called a “clinically relevant” improvement in disability and function.

Add it all up, and ReNeuron says it’s ready to test their approach in a pivotal study.

The biotech (AIM: RENE), which is backed by Sir Chris Evans, is operating in a badly unsettled field right now. A whole string of stem cell therapies has proven to be a disappointment, casting a pall over R&D in the sector. Today’s update from ReNeuron is unlikely to change that score.

Professor Keith Muir had this to say in a statement:

“The findings of the PISCES II study are encouraging in that the CTX treatment shows improvements both in specific neurological problems, such as arm function, and also in more general disability and independence. These improvements occurred in sufficient numbers of patients to warrant further investigation in a larger, controlled clinical study. Further, the CTX treatment was well tolerated in this Phase II study, which confirms and adds to the results of the earlier Phase I clinical trial.”

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

Visit Endpoints Careers ->