With an eye on FDA discussions later this year, biotech Asterias (NYSE: AST) is harnessing the potential of regenerative medicine to improve the quality of life of patients with spinal cord injuries (SCI). Recent efficacy results from the ongoing phase 1/2a clinical trial showed that SCI patients treated with the company’s AST-OPC1 cells demonstrated improved ability to use their arms, hands and fingers. Company CEO Steve Cartt in a press release called the results encouraging as Asterias plans for discussions with the FDA in mid-2017 to determine the appropriate strategy for regulatory approval. According to the World Health Organization, between 250,000 and 500,000 people have an SCI each year, 20-30% of which show clinically significant signs of depression, further impacting improvements in function and overall health. As Asterias reports, SCI injuries can greatly affect a patient’s quality of life and ability to function independently, also racking up lifetime health care costs of up to $5 million. Improvements in motor function can reduce health care costs and improve quality of life and independence.
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About Asterias Biotherapeutics
Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its immunotherapy and pluripotent stem cell platform technologies. 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-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias after demonstrating promise in a Phase 2 study in Acute Myeloid Leukemia (AML) and completing a successful end-of-Phase 2 meeting with the FDA. The company is currently focused on streamlining and modernizing the manufacturing process for AST-VAC1 in advance of a planned initiation of a confirmatory phase 2b study. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in the first half of 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com
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