ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology company developing and commercializing products addressing degenerative diseases, announced that it has achieved an important patient enrollment milestone in its Renevia® pivotal trial in Europe. The company now has more than 50 patients in the trial, keeping it on track with the anticipated forecast for top-line data by the middle of 2017.
“We are pleased with the progress in our Renevia pivotal trial,” commented Adi Mohanty, Co-Chief Executive Officer of BioTime. “Now that we have completed treatment of nine run-in patients, and randomized over another 50 into our trial, we have enough patients to remain on track for our previously communicated target of mid-year 2017 top-line data. We will continue to recruit a few more patients in order to account for any unforeseen study dropouts. We are very encouraged by the progress so far and the continued safety of Renevia after more than 60 total patients at our trial sites. The achievement of this milestone comes just after the encouraging early data reported at the IFATS annual meeting in San Diego in November of this year.”
Mr. Mohanty continued, “While this trial will support approval for use in the treatment of HIV-related facial lipoatrophy in Europe, the data so far has encouraged us to actively assess broader indications for Renevia such as facial volume deficit. We are also actively working on plans for other large aesthetic markets like South Korea and Brazil as well as the U.S.”
Developed as an alternative for whole adipose tissue fat transfer procedures, Renevia is designed to mimic the naturally-occurring 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. 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, and consistent with the run-in patients, the company plans to file the data as the basis for CE marking in the second half of 2017.
BioTime, Inc. is a clinical-stage biotechnology company focused on developing and commercializing products addressing degenerative diseases. The foundation of BioTime’s core therapeutic technology platform is pluripotent cells. Pluripotent cells 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.
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.
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