BioTime, Inc. today announced the completion of a safety trial evaluating Renevia ™, a proprietary injectable matrix designed to facilitate the stable engraftment of transplanted cells, and the results of that study.
The ten healthy volunteers each received one subcutaneous injection of Renevia ™ without cells ( Renevia ™ -01 safety study). The primary objective of the trial was to determine the safety and tolerability of Renevia ™ as determined by post-treatment patient monitoring for adverse reactions. Examinations of the subjects during the trial period have shown that Renevia ™ was well tolerated by all subjects with no serious adverse events or subject withdrawals.
The Renevia ™ -01 safety study was completed on November 4, 2013 and a four week follow-up procedure evaluating the trial subjects has been completed. The trial was conducted at The Stem Center ( www.stem-center.com ) in Palma de Mallorca, Spain, located within the hospital Clinica USP Palmaplanas in Palma. The Medical Director of the Center and the Principal Investigator of this study is Dr. Ramon Llull, MD, PhD, a leading expert on advanced regenerative therapies based on adipose cell technology. A clinical study report is being drafted for submission to the local ethics committee and Spanish National Regulatory Authorities.
The protocol for a pivotal clinical study ( Renevia-02) is under development and submission to Spanish regulatory authorities is planned for the first quarter of 2014. This latter clinical study is intended to document the efficacy of Renevia ™ as a delivery matrix for adipose cells to restore normal skin contours in patients where the subcutaneous adipose tissue has been lost to lipoatrophy, specifically HIV-related facial lipoatrophy. Lipoatrophy is a localized loss of fat beneath the skin and is often a consequence of the normal aging process, but lipoatrophy can also be associated with trauma, surgery, and specific diseases. For example, lipoatrophy is a frequent disorder experienced by HIV patients being treated with antiviral drugs. According to published estimates, at least several hundred thousand patients in Europe, and a similar number in the U.S., are affected by lipoatrophy and related conditions such as lipodystrophy. These patients have very limited treatment options and these conditions therefore represent a significant unmet medical need. The Renevia-02 study will be conducted at The Stem Center in Mallorca with Dr. Ramon Llull as its principal investigator. BioTime’s plans to proceed with the Renevia-02 pivotal clinical trial subject to obtaining required regulatory and institutional approvals.
Renevia ™ is manufactured in the US in compliance with cGMP requirements and has been tested pursuant to ISO 10993 standards for implantable medical devices and shown to be biocompatible without adverse effects in animal studies. BioTime has submitted a Device Master File (called an MAF) to the United States Food and Drug Administration with the details of the manufacturing, testing, and biocompatibility of the HyStem® hydrogels, of which Renevia ™ is one version. The MAF was filed in order to allow the FDA to easily access the manufacturing and biocompatibility information to support any future clinical studies that third party investigators may elect to initiate for their cell or drug products utilizing HyStem® hydrogels.