BioLife Solutions Congratulates DCPrime on Its Approved Orphan Medicinal Product Application for DCOne™ Leukemia Vaccine Therapeutic Cells Are Frozen in CryoStor® GMP Cryopreservation Media, Shipped to the Clinic, Thawed and Injected into Cancer Patients
BOTHELL, Wash., Feb. 6, 2012 /PRNewswire/ -- BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, today recognized its customer DCPrime, a Dutch clinical stage company, on receiving orphan drug designation by the Committee for Orphan Medical Products (COMP) of the European Medicines Agency of DCPrime's novel DCOne™ platform vaccine indicated for Acute Myeloid Leukemia (AML).
"This orphan drug designation is a major step in DCPrime's work towards approval of our AML vaccine, and clearly reflects the COMP's view of the potential of this vaccine in improving survival of patients with AML," said DCPrime Chief Executive Officer and Chief Scientific Officer Dr. Ada Kruisbeek.
Mike Rice, BioLife Chief Executive Officer, commented on DCPrime's selection of CryoStor by stating, "We congratulate Dr. Kruisbeek and her team on achieving this milestone. We're pleased to see continued adoption of our novel biopreservation media products in cellular therapy and regenerative medicine applications. The biopreservation efficacy and quality and safety profile of our products are driving increased demand as the regulatory environment for reagents used in the manufacturing, transportation and clinical administration of cell-based products continues to evolve and become more strenuous for our customers."
Kruisbeek continued, "Finding a clinical grade freeze media for DCPrime's final vaccine dose was a high priority. We considered the cost and quality aspects of formulating a freeze media in-house against selecting a pre-formulated GMP manufactured commercial product, and completed a series of comparative experiments. CryoStor clearly outperformed all other formulations in biopreservation efficacy, and its serum-free, protein-free formulation supported our quality requirements."
DCPrime is a Dutch clinical stage company, dedicated to developing cancer vaccines based on its proprietary dendritic cell (DC) technology platform DCOne™. With this platform, the company can generate off‐the‐shelf DC‐based vaccines for a broad range of cancer types. DCOne‐based DC vaccines share all immune‐stimulatory properties with patient derived DC‐based vaccines, and have the simple logistics of off‐the‐shelf products. A commercial scale manufacturing process to produce DCOne‐based vaccines has been developed, and DCPrime's lead product DCP‐001 is in the clinic in a Phase I/IIa study in patients with Acute Myeloid Leukemia (AML). Several products for solid cancers are in preclinical development, using peptide loaded DCOne‐based vaccines. With this powerful platform, DCPrime has the opportunity to become the gold standard for off‐the‐shelf dendritic cell products.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets patented hypothermic storage and cryopreservation solutions for cells and tissues. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are marketed to academic and commercial organizations involved in cell therapy, tissue engineering, cord blood banking, drug discovery, and toxicology testing. BioLife's products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced, delayed-onset cell damage and death. BioLife's enabling technology provides academic and clinical researchers significant improvements in post-thaw cell, tissue, and organ viability and function. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.
This news release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements include any statements that relate to the intent, belief, plans or expectations of the Company or its management, or that are not a statement of historical fact. Any forward-looking statements in this news release are based on current expectations and beliefs and are subject to numerous risks and uncertainties that could cause actual results to differ materially. Some of the specific factors that could cause BioLife Solutions' actual results to differ materially are discussed in the Company's recent filings with the Securities and Exchange Commission. BioLife Solutions disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
SOURCE BioLife Solutions, Inc.