BioTime (BTX) Announces Presentation of Positive Data from Renevia Pivotal Trial

November 18, 2016 5:55 AM EST

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BioTime, Inc. (NYSE: BTX) announced details of positive data from its Renevia pivotal trial, reported via a presentation at the 14th annual International Federation for Adipose Therapeutics and Science meeting (IFATS) on Thursday, November 17, in San Diego. The presentation was based on data from the “run-in,” testing sample subjects to the European pivotal trial.

The presentation, titled “Stromal Cell-Hydrogel Construct Possibly Generates Clinically Relevant Neo-Tissue In Facial HIV-Lipoatrophy Pivotal Multicenter Clinical Trial: Early Analysis On Testing Patient Sample,” was given by Ramon Llull, M.D., Ph.D., director of the Stem Europe Mallorca Center, in Spain, and the principal investigator of the trial.

Highlights of the presentation included:

  • Adipose progenitor cells (fat cells) obtained from a liposuction aspirate remained viable and were observed to proliferate when combined with the Renevia hydrogel
  • The Renevia gel and progenitor cells were successfully administered in the run-in subjects with no serious adverse events
  • 3D-image analysis suggests that the grafts retained volume over the assessment period, and the treating physician-observed incremental volume was retained in select patients who had progressed to the one-year follow-up evaluation

“We are encouraged that the administration of Renevia worked well in these patients,” commented Dr. Llull. “Existing methods used to address HIV and age-related facial volume loss provide only temporary solutions. We are seeing signs indicating that Renevia may be able to generate new facial tissue which could result in more natural, longer-lasting outcomes.”

Developed as an alternative for whole adipose tissue fat transfer procedures, Renevia is designed to mimic the naturally-occuring extracellular matrix and provide a 3-D scaffold that enables effective cell transplant and engraftment. In the run-in portion of this trial, the Renevia administration procedure was found to be reproducible, and the pivotal trial is now into its controlled phase. Encouraging signs of Renevia being able to promote new tissue generation were seen with the run-in practice patients. If the pivotal trial is successful, the company plans to file the data as the basis for the issuance of CE marking for European use. CE marking is anticipated as early as the second half of 2017.



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