AST-OPC1 has Demonstrated Positive Safety Profile and Promising Signs of Efficacy in a Phase 1/2a Trial for Severe Spinal Cord Injury
FREMONT, Calif., July 12, 2018 (GLOBE NEWSWIRE) — Asterias Biotherapeutics, Inc. (NYSE American:AST), a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer, today announced that it has entered into an exclusive license agreement with The Regents of the University of California. Under the agreement, the Company has exclusive rights in all fields of use for a patent family that claims a method of improving recovery in a patient that has suffered an ischemic stroke by administering to the patient stem cell-derived oligodendrocyte progenitor cells. The pending patent applications in the US, Canada, China, Japan, Australia, and before the European Patent Organization that are included in the exclusive license were filed after initial testing of AST-OPC1, the Company’s pluripotent stem cell derived oligodendrocyte progenitor cell product, in a rodent model of white matter ischemia in collaboration with Dr. S. Thomas Carmichael, M.D., Ph.D., Chair and Professor of Neurology at the University of California, Los Angeles (“UCLA”). The pending patents are jointly owned by The Regents of The University of California and Asterias, with The Regents granting the Company an exclusive license to its share of the IP rights.
The exclusive license agreement with the Regents of the University of California is a part of the Company’s strategy to explore the efficacy of its AST-OPC1 product candidate in other neurological conditions. AST-OPC1 is currently in a Phase 1/2a clinical trial in severe spinal cord injury (NCT02302157).
“The preliminary results of our ongoing spinal cord injury trial are encouraging and we are excited to begin to expand our neurology platform to other indications,” commented Michael Mulroy, President and Chief Executive Officer. “We look forward to exploring whether our AST-OPC1 product candidate can help patients that have suffered an ischemic stroke and other patients with demyelinating conditions where there is a large, unmet medical need.”
The Company also announced that it has initiated testing of AST-OPC1 in a second pre-clinical model of subcortical and white matter ischemia in collaboration with a leading expert in pre-clinical models of cerebral ischemia and cell transplantation.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company dedicated to developing cell-based therapeutics to treat neurological conditions associated with demyelination and cellular immunotherapies to treat cancer. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC2 (antigen-presenting allogeneic dendritic cells) is an allogeneic cancer immunotherapy. The company’s research partner, Cancer Research UK, has commenced a first-in-human clinical trial of AST-VAC2 in non-small cell lung cancer. AST-VAC1 (antigen-presenting autologous dendritic cells) is an autologous cancer immunotherapy with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML). Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, 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,” “explores”) 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 businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.