Positive Early Data From BioTime’s Renevia Pivotal Trial Presented at IFATS Meeting
18.11.2016 08:00 | Business Wire
BioTime, Inc. (NYSE MKT: BTX), a clinical-stage biotechnology company with a focus on pluripotent cell-based technologies, 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.
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing novel therapies developed from what the company believes to be the world’s premier collection of pluripotent cell assets. The foundation of BioTime’s core therapeutic technology platform is pluripotent cells that are capable of becoming any of the cell types in the human body. Pluripotent cells have potential application in many areas of medicine with large unmet patient needs, including various age-related degenerative diseases and degenerative conditions for which there presently are no cures. Unlike pharmaceuticals that require a molecular target, therapeutic strategies based on the use of pluripotent cells are generally aimed at regenerating or replacing affected cells and tissues, and therefore may have broader applicability than pharmaceutical products.
In addition to the development of therapeutics, BioTime’s research and other activities have resulted, over time, in the creation of other subsidiaries that address other non-therapeutic market opportunities such as cancer diagnostics, drug development and cell research products, and mobile health software applications.
BioTime common stock is traded on the NYSE MKT and TASE under the symbol BTX. For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime, Inc. specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: http://news.biotimeinc.com.
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