BioLife Solutions CryoStor® Freeze Media Adopted by TxCell for Ovasave® Regulatory T Cell-Based Personalized Immunotherapy
BOTHELL, Wash., June 16, 2014 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues today announced that Nice, France-based TxCell (Euronext Paris: TXCL) a biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, has adopted BioLife's CryoStor clinical grade cell freezing media for use in their European phase IIb clinical trial of Ovasave immunotherapy in refractory Crohn's Disease, which is planned to start in the second half of 2014.
Ovasave is TxCell's lead product candidate and is classified as an Advanced Therapy Medicinal Product (ATMP) by the European Medicines Agency.
Mike Rice, BioLife's President & CEO, said, "We are very pleased to support TxCell in their development and potential commercialization of Ovasave cell-based immunotherapy. TxCell joins a growing list of personalized medicine immunotherapy companies that have adopted our clinical grade biopreservation media products to optimized stability and viability of cellular source materials and manufactured cell products. Biopreservation yield has a significant impact on manufacturing costs and geographic distribution, both of which affect commercial potential for novel regenerative medicine products and therapies."
The November 2013 vision gain Translational Regenerative Medicine market research report forecasts that the regenerative medicine market comprised of cell and gene therapies and tissue-engineered products will grow to more than $23 billion by 2024. BioLife expects to participate in this market growth by providing biopreservation media and precision thermal packaging products used to store, freeze, ship, and administer clinical cells and tissues to patients. To date, BioLife's proprietary biopreservation media products have been incorporated into over 100 hospital-approved and clinical trial stage regenerative medicine products and therapies.
Arnaud Foussat, Ph.D., TxCell Vice President of Research and New Products, commented on the adoption of CryoStor for post-manufacturing storage and delivery of Ovasave by stating, "We evaluated several traditional cryopreservation media formulations and products and found CryoStor improves post-preservation survival and stability before infusion compared to the alternatives. Retention of cellular function of our antigen-specific Treg cell therapy product appeared to be in line with quality expectations. In addition, the quality and manufacturing profile of CryoStor supported our decision to work with BioLife on this important aspect of our manufacturing and clinical delivery processes."
TxCell is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary ASTrIA technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has completed a phase I/IIa study of its lead product candidate, Ovasave® in refractory Crohn's disease patients and has reported good tolerability and positive clinical efficacy. The company plans to initiate a phase IIb study in the same patient population. TxCell has a strategic partnership for Ovasave with the Swiss company Ferring International Center.
Listed on Euronext-Paris, TxCell, a spin-off of Inserm (France's National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. The company has 38 employees based at its headquarters and at its manufacturing site in Besançon. For more information, please visit www.txcell.com
Practical Information about TxCell shares:
ISIN code FR0010127662
Ticker code TXCL
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife's enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This press release contains forward-looking statements, including, but not limited to, statements concerning our 2014 outlook, potential revenue growth and market expansion, new products and customers, the potential benefits of our NASDAQ listing, and the timing and potential consequences of the termination of our agreement with ORS and the related tail period provisions. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of our products; market volatility; competition; litigation; uncertainty regarding our ability to reduce or reallocate overhead expenses related to ORS; the need to negotiate and execute definitive agreements with SAVSU Technologies, Inc., in order to proceed with the planned biologistex product line; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.
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SOURCE BioLife Solutions, Inc.