BioLife Solutions Customer TiGenix Phase 3 Clinical Trial Meets Primary Endpoint
BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers ("BioLife" or the "Company"), today announced that its customer TiGenix NV, an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, recently disclosed that its lead compound Cx601 met the primary endpoint in the Phase III ADMIRE-CD trial of complex perianal fistula in Crohn's Disease patients. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally. A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs. The study results confirm the favorable safety and tolerability profile of Cx601. Key results include:
A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24 of complex perianal fistulas in Crohn's disease patients with inadequate response to previous therapies, including anti-TNFs
More than 50% of patients treated with Cx601 achieved combined remission at week 24
A higher number of Cx601-treated patients had their fistulas closed by week 6
The results confirm the favorable safety and tolerability profile of Cx601
These positive data allow for European filing in the first quarter of 2016 and moving forward in the US with the SPA-approved pivotal study.
Mike Rice, BioLife's President & CEO, said, "We congratulate the entire TiGenix team on this outstanding accomplishment. All of us at BioLife are pleased to be a critical biopreservation tools supplier to TiGenix and are proud to know that our clinical grade HypoThermosol cell storage and shipping media is helping to commercialize another novel cellular therapy."
BioLife managements estimates that HypoThermosol and the Company's companion CryoStor® clinical grade freeze media are incorporated into at least 200 pre-clinical validation projects and clinical trials of new cell and tissue based products and therapies.
In July 2015, Frost & Sullivan forecasted that the stem cell therapy market is expected to be worth $40 billion by 2020 and $180 billion by 2030.
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