BioTime, Inc. (NYSE MKT:BTX), a clinical stage biotechnology company with a focus on pluripotent stem cell technologies, today announced that an abstract evaluating Renevia® in ‘run-in’ patients with HIV-associated facial lipoatrophy from the Renevia-02 trial will be presented at the 14th annual International Federation for Adipose Therapeutics and Science meeting (IFATS) taking place from November 17-20, 2016, in San Diego, California. The data will be reported in an oral presentation on Thursday, November 17.
The presentation will be given by Ramon Llull, MD, PhD, director of Stem Europe Mallorca Center in Mallorca, Spain, and the principal investigator of the Renevia trial. Dr. Llull will present data from ‘run-in’ patients in the pivotal trial. The data indicate that Renevia was safely administered with no serious adverse events and 3-D imaging suggests that volumetric improvements were sustained through a one-year follow up. In addition, Dr. Llull will present the mechanistic rationale and pre-clinical data on how Renevia may be able to generate new facial tissue after transplantation.
Thursday, November 17
“Stromal Cell-Hydrogel Construct Possibly Generates Clinically Relevant Neo-Tissue In Facial HIV-Lipoatrophy Phase 2 Pivotal Multicenter Clinical Trial: Early Analysis On Testing Patient Sample”.
Ramon Llull, MD, PhD, Stem Europe Mallorca Center, Mallorca, Spain
Additionally, data from the laboratory of Derrick C. Wan, MD, Associate Professor in the Department of Surgery at Stanford University Medical Center, will be presented on pre-clinical data from the transplantation of Renevia into a novel mouse model.
Thursday, November 17
“Three Dimensional Ultrasound For The Accurate Imaging And Quantification Of Adipose And Synthetic Tissue Grafts”.
Charles P. Blackshear MD, MD, Department of Surgery, Stanford University Medical Center
About Facial Lipoatrophy
Facial wasting or facial lipoatrophy is the loss of subcutaneous fat from the face and is associated with medication for treatment of HIV infection. The longer a person is on HIV medications, the greater the likelihood of developing problems with facial wasting. Signs of lipoatrophy include the loss of subcutaneous fat primarily in the temporal region and cheeks and this tends to produce an emaciated appearance.
About Renevia ®
Renevia® is a medical device that was developed as a replacement for whole adipose tissue in cell assisted lipotransfer (CAL) procedures by recreating many aspects of the adipose tissue extracellular matrix. Renevia’s hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and supports proliferation, localization, and adipogenic differentiation. Once implanted, Renevia provides a 3-dimensional matrix with pliability comparable to that of native adipose tissue, restoring texture in the short term while promoting soft tissue regeneration in the long term.
An important attribute of the Renevia hydrogel is its high water content, which is greater than 98 percent. As a result, the hydrogel is highly permeable to oxygen, nutrients and other water-soluble metabolites. Renevia mimics the extracellular matrix and the individual components of the hydrogel can be cross-linked in situ, thereby allowing the seeding of cells prior to injection in vivo without compromising either the cells or the recipient tissues.
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+.
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Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime 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 and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
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Last updated on: 01/11/2016
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