CryoStor Cell Preservation Selected For Phase III Clinical Trials of C-Cure Cell Therapy for Congestive Heart Failure

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 (BioLife or the Company), today announced that Cardio3 BioSciences, a leader in engineered cell therapy with clinical programs initially targeting indications in cardiovascular disease and oncology, has embedded the Companys clinical grade CryoStor cryopreservation freeze media in its ongoing Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) phase III clinical trial in Europe and Israel and the pending CHART-2 phase III clinical trial to be conducted in the United States.

CHART-1 (Congestive Heart Failure Cardiopoietic Regenerative Therapy) is a patient prospective, controlled multi-centre, randomized, double-blinded Phase III clinical trial comparing treatment with C-Cure to a sham treatment. The trial has recruited 240 patients with chronic advanced symptomatic heart failure. The primary endpoint of the trial is a composite endpoint including mortality, morbidity, quality of life, Six Minute Walk Test and left ventricular structure and function at nine months post-procedure.

Dr. Christian Homsy, CEO of Cardio3 BioSciences, commented on the selection of CryoStor by stating, We evaluated several possible freeze media formulations for our clinical cell therapy product development and manufacturing. CryoStor and BioLife best met our preservation efficacy, product and supplier quality, and customer support requirements.

As of January 2015, BioLife management estimates that the Companys CryoStor freeze media and HypoThermosol cell and tissue storage/shipping media have been incorporated into at least 175 customer clinical trials of novel cellular immunotherapies and other cell-based approaches for treating and possibly curing the leading causes of death and disorders throughout the world. Within the cellular immunotherapy segment of the regenerative medicine market, BioLife's products are embedded in the manufacturing, storage, and delivery processes of at least 75 clinical trials of chimeric antigen receptor T cells (CAR-T), T cell receptor (TCR), dendritic cell (DC), tumor infiltrating lymphocytes (TIL), and other T cell-based cellular therapeutics targeting solid tumors, hematologic malignancies, and other diseases and disorders. A large majority of the currently active private and publicly traded cellular immunotherapy companies are BioLife customers.

Mike Rice, BioLife Solutions CEO, remarked; We are honored to be able to supply our clinical grade CryoStor cell freeze media for Cardio3 Biosciences phase III clinical trials. Congestive heart failure is a leading cause of death and C-Cure is a novel and potentially life-saving, cell-based therapy that offers hope to millions of patients throughout the world. We are very well positioned to participate in the growth of the regenerative medicine market, with our products being used in at least 75 phase II and over 20 phase III clinical trials of new cell and tissue based products and therapies.

About Cardio3 Biosciences Cardio3 BioSciences is a leader in engineered cell therapy with clinical programs initially targeting indications in cardiovascular disease and oncology. Founded in 2007 and based in the Walloon region of Belgium, Cardio3 BioSciences leverages research collaborations in the USA with the Mayo Clinic (MN, USA) and Dartmouth College (NH, USA). The Companys lead product candidate in cardiology is C-Cure, an autologous stem cell therapy for the treatment of ischemic heart failure. The Companys lead product candidate in oncology is CAR- NKG2D, an autologous CAR T-cell product candidate using NKG2D, a natural killer cell receptor designed to target ligands present on multiple tumor types, including ovarian, bladder, breast, lung and liver cancers, as well as leukemia, lymphoma and myeloma. Cardio3 BioSciences is also developing medical devices for enhancing the delivery of diagnostic and therapeutic agents into the heart (CCath) and potentially for the treatment of mitral valve defects. Cardio3 BioSciences shares are listed on Euronext Brussels and Euronext Paris under the ticker symbol CARD. To learn more about Cardio3 BioSciences, please visit c3bs.com

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CryoStor Cell Preservation Selected For Phase III Clinical Trials of C-Cure Cell Therapy for Congestive Heart Failure