MENLO PARK, Calif., Nov. 18, 2014 /PRNewswire/ -- Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a leading biotechnology company in the emerging field of regenerative medicine, today announced that the Company’s lead clinical program, AST-OPC1 (oligodendrocyte progenitor cells) for complete cervical spinal cord injury (SCI), has been selected as one of ten “Top Advanced Therapies Projects to Watch” by Elsevier Business Intelligence.
“We are delighted to receive this significant industry honor, which represents independent validation of the value of AST-OPC1 as a potential therapy for patients,” commented Pedro Lichtinger, President and CEO of Asterias. Mr. Lichtinger will present at Elsevier’s Therapeutic Area Partnerships Conference taking place in Boston during November 19-21, 2014.
Elsevier considered a strict set of judging criteria when selecting the Top 10 Advanced Therapies Projects to Watch. These are handpicked by a panel of independent experts who screen hundreds of compounds and weigh their potential as future products. The criteria are: large market, large unmet need, increasing opportunity; history of the molecule and drug; strong science; strong company; diversity of indications; potential for new opportunities beyond the initial indications; and multilevel partnering opportunities.
Mr. Lichtinger will present an overview of AST-OPC1, which successfully completed a Phase 1 clinical trial and met its primary endpoints of safety and feasibility when administered to five patients with neurologically-complete, thoracic spinal cord injury. Asterias received clearance from the U.S. Food and Drug Administration (FDA) in August 2014 to initiate a dose-escalation Phase 1/2a clinical trial of AST-OPC1 in patients with complete cervical SCI. Asterias recently announced an initiative to accelerate the current timelines for the AST-OPC1 clinical program by approximately six months in order to obtain safety and efficacy readouts more rapidly. In addition, the Company plans to seek FDA approval to increase the robustness of the proof of concept in the Phase 1/2a clinical trial by expanding enrollment from 13 patients to up to 40 patients. The Company believes these changes will increase the statistical confidence of the safety and efficacy readouts, reduce the risks of the AST-OPC1 program and position the product for potential accelerated regulatory approvals. Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.
About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. (NYSE MKT: AST) is a leading biotechnology company in the emerging field of regenerative medicine. The Company’s core technologies center on pluripotent stem cells, which are characterized by the ability to become all cell types in the human body. Asterias is focused on developing therapies based on pluripotent stem cells to treat diseases or serious injuries in several medical areas where there is high unmet medical need and without adequate available therapies. Asterias’ two clinical development programs, AST-OPC1 (oligodendrocyte progenitor cells) for spinal cord injuries and AST-VAC2 (antigen-presenting allogeneic dendritic cells) for lung cancer, are based on the Company’s proprietary technology platforms of Pluripotent Stem Cells and Allogeneic Dendritic Cell Immunotherapy, respectively. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating 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”) 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.
SOURCE Asterias Biotherapeutics, Inc.
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