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news.Fibrocell Science has announced that Progenitor Cell Therapy (PCT), a subsidiary of NeoStem (NBS), has been engaged by Fibrocell’s collaborator, Intrexon Corporation (XON), to provide production capabilities in the generation of cell therapies for the rare disease Recessive Dystrophic Epidermolysis Bullosa (RDEB).
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Fibrocell’s clinical program for RDEB will utilize PCT’s manufacturing expertise and resources to implement the production process for transfer and clinical manufacturing of genetically-modified cell therapies.
The manufacturing services provided by PCT will augment manufacturing capacity available to Fibrocell through Intrexon, allowing Fibrocell to focus its internal operations on its pipeline of personalized biologic cell therapies.
"We are excited about the significant progress we are making in advancing the RDEB program for this priority drug candidate," said David Pernock, chairman and chief executive officer of Fibrocell.
"This is a strategic decision to outsource manufacturing and intensify our internal resources on our pipeline of promising drug candidates, and it gives us manufacturing flexibility for our RDEB program, upcoming Phase 3 clinical trials, and other future needs."
"We thank Intrexon and its collaborator Fibrocell, for the trust they have placed in PCT by choosing us for this work," said Dr. Robert Preti, Chief Scientific Officer of NeoStem and PCT, and President of PCT. "We are confident that PCT’s manufacturing resources, along with our newly established Engineering and Innovation Center, will help to strengthen and advance the RDEB program."
The process development for the RDEB program will integrate Fibrocell’s Azficel-T Autologous Fibroblast technology with Intrexon Corporation’s UltraVector technology, and represents the first of several drug development programs from the collaboration of Fibrocell and Intrexon to create genetically-modified personalized biologics for rare skin and connective tissue diseases.
The engagement with PCT will enable advances in the process development and manufacturing of genetically-modified personalized biologics for the RDEB drug development program and could also be extended to allow for contract manufacturing of other fibroblast cell therapies that are product candidates of the Fibrocell-Intrexon collaboration.
PCT will begin technology transfer and process development for the RDEB program immediately to align with the timeline for the Fibrocell/Intrexon RDEB drug development program, which is on track to present proof of concept data this year and is expected to advance to Phase I clinical studies in the first half of 2015.