Fibrocell Science Announces Plans for Process Development and Manufacturing of Genetically-modified Cell Therapy for Rare Disease, RDEB Business Wire EXTON, Pa. -- May 28, 2014 Fibrocell Science, Inc., (NYSE MKT:FCSC), an autologous cell therapy company primarily focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs, announced today that Progenitor Cell Therapy (PCT), a subsidiary of NeoStem, Inc. (NASDAQ:NBS), has been engaged by Fibrocell’s collaborator, Intrexon Corporation (NYSE:XON), to provide production capabilities in the generation of cell therapies for the rare disease Recessive Dystrophic Epidermolysis Bullosa (RDEB). 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. About Fibrocell Science, Inc. Fibrocell Science, Inc. (NYSE MKT:FCSC) is an autologous cell therapy company primarily focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs. Based on its proprietary autologous fibroblast technology, Fibrocell is pursuing breakthrough medical applications of Azficel-T for restrictive burn scarring and vocal cord scarring. The company’s collaboration with Intrexon Corporation (NYSE:XON), a leader in synthetic biology, includes using genetically-modified fibroblasts for treating rare and serious skin and connective tissue diseases for which there are no currently approved products. For additional information, visit www.fibrocellscience.com. About PCT Progenitor Cell Therapy (PCT), a wholly owned subsidiary of NeoStem, Inc. (NASDAQ:NBS), is a leading contract development and manufacturing organization in the cellular therapy industry. For over 15 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing regenerative medicine product candidates from the development stage all the way through to human testing. PCT has two cGMP-compliant, state-of-the art facilities in New Jersey and California to serve the cell therapy industry and offers manufacturing of cell therapy-based products, engineering and innovation services, process and product development, cell and tissue processing, collection and storage, regulatory consulting, facility design, validation, and due diligence evaluations. www.pctcelltherapy.com Safe Harbor Statement Some of the statements made in this press release are forward-looking statements. Forward-looking statements include, without limitation, the ability of Fibrocell to present proof of concept data this year for its RDEB study and to develop breakthrough therapies for the treatment of skin and connective tissues diseases. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Contact: Corporate: Fibrocell Science, Inc. Gregory Weaver, +1-484-713-6000 SVP & Chief Financial Officer email@example.com or Investor Relations: S.A. Noonan Communications, LLC Susan Noonan, +1-212-966-3650 firstname.lastname@example.org
Fibrocell Science Announces Plans for Process Development and Manufacturing of Genetically-modified Cell Therapy for Rare
Press spacebar to pause and continue. Press esc to stop.