BioTime, Inc. (BTX) announced that the FDA has granted permission to its subsidiary, Asterias Biotherapeutics, Inc., for the initiation of a phase I/IIa study on AST-OPC1.
The open label, single-arm phase I/IIa study will evaluate the safety and activity of three escalating doses of AST-OPC1 in patients suffering from subacute, C5-C7, neurologically-complete cervical spinal cord injury (SCI). BioTime intends to start patient enrollment during the first quarter of 2015.
With the FDA clearance, BioTime is now eligible for a grant of $14.3 million from the California Institute for Regenerative Medicine (CIRM). The CIRM will provide funding for the development of AST-OPC1 for SCI, expanding the scope of the study in future and manufacturing and commercialization of AST-OPC1.
BioTime expects the results from the phase I/IIa study to support a phase IIb expansion study. The expansion study will be conducted to demonstrate the safety and efficacy of AST-OPC1, thoroughly.
According to the press release issued by BioTime, no therapy is yet approved for the treatment of SCI. While more than 12,000 people are estimated to suffer from SCI every year in the U.S. alone, nearly 1.3 million Americans live with this condition. Traumatic SCI is most commonly found to affect people in their 20s and 30s.
We expect investor focus to remain on further updates related to AST-OPC1.
Investors looking for well-positioned stocks in the biotech sector may consider Gilead Sciences Inc. (GILD), Amgen Inc. (AMGN) and Regado Biosciences, Inc. (RGDO). All these stocks carry a Zacks Rank #1 (Strong Buy).
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