BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, announced that Chief Executive Officer Michael D. West, Ph.D. will provide an update today on five products being developed by BioTime and its subsidiaries during a presentation at the World Stem Cell Summit 2012 in West Palm Beach, Florida in the session on “Developing Combination Products: Cells, Genes, and Devices” at 1:30 pm EST. The presentation will be made available on BioTime's website at
BioTime’s technology platform utilizes pluripotent stem cells that are capable of differentiating into any of the cell types in the body to produce potentially novel first-in-class regenerative therapies for largely unsolved problems in medicine. Using the Company’s proprietary
technology, BioTime has more than 200 novel and scalable cellular components of the human body.
Dr. West will present for the first time information relating to 18 novel and diverse progenitor cell lines capable of differentiating into diverse cartilage and bone types, as well as producing cells with markers of tendon, and brain meningeal tissues. The cartilage progenitor formulation designated OTX-CP07 is being developed by BioTime’s subsidiary OrthoCyte Corporation, and is currently beginning the process of animal studies of safety and efficacy for the treatment of intervertebral disc disease. The cartilage, bone, and tendon-producing cell lines may have significant applications in the treatment of orthopedic disorders such as osteoarthritis and low back pain resulting from intervertebral disc disease, while the subset of lines capable of choroid plexus differentiation may have application in the treatment of Alzheimer’s disease.
For many of the wide array of cell-based regenerative therapies being developed around the world, the formulation of the cells with a matrix is desired to increase viable and immobilized engraftment.
is designed to be an effective means of transplanting cells in an injectable liquid that can polymerize safely in the body into a tissue construct. Dr. West will report that validation of the analytical methods and manufacturing processes for
are substantially complete. Production of one of
four manufacturing components under Current Good Manufacturing Practice (cGMP) is completed and cGMP production of the remaining three components is scheduled. Clinical trial protocols (three phases) are being drafted and BioTime anticipates that during the first quarter of 2013 a submission of the
Phase I safety trial in humans will be made to the appropriate Spanish Ethics Committee for review and approval. In addition, he will report continued progress on establishing quality management systems for compliance with ISO 13485 (required in the EU for medical devices) and that preliminary review and audit (by an external auditor) is currently scheduled for the first quarter of 2013 with the final ISO audit expected during the second quarter.
, being developed by BioTime’s subsidiary OncoCyte Corporation,
is intended to be a blood-based screening diagnostic for a wide array of solid tumor types. Recent reports of the relative ineffectiveness of mammography in reducing patient death from breast cancer highlight the urgent need for improved tools to accurately detect the disease in its earliest stages. Dr. West will report that OncoCyte has initiated production of monoclonal antibodies to the first seven of its priority cancer markers. In addition, OncoCyte has completed the characterization of over 50 antibodies in order to screen for the subset with greatest specificity for each individual marker. Dynamic testing of the antibodies for use in ELISA and point of care formats are currently underway.
Dr. West will describe the current need for retinal pigment epithelial (RPE) cells free of animal products for the treatment of the dry form of age-related macular degeneration (AMD). Dr. West will discuss how such cells could aid in eliminating the need for designating a product as a xenotransplantation therapeutic. Dr. West will describe the ongoing preclinical studies at BioTime’s subsidiary Cell Cure Neurosciences Ltd., which are expected to lead to regulatory filings for the initiation of human clinical trials in 2013.