BioLife Solutions Customer TiGenix Phase 3 Clinical Trial Meets Primary Endpoint

HypoThermosol® Cell Storage/Shipping Media to be Used in Commercial Manufacturing of Allogeneic Expanded Stem Cells for Complex Perianal Fistula in Crohn's Disease Patients

Aug 31, 2015, 06:00 ET from BioLife Solutions, Inc.

BOTHELL, Wash., Aug. 31, 2015 /PRNewswire/ -- 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.

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn's disease patients. Cx611 has completed a Phase I/II trial in rheumatoid arthritis, as well as a Phase I sepsis challenge trial. Effective as of July 31, 2015,

TiGenix acquired Coretherapix, whose lead cellular product (AlloCSC-01) is currently in a Phase II clinical trial in acute myocardial infarction (AMI). Coretherapix is planning to initiate the clinical evaluation of AlloCSC-01 in the chronic setting as well and is also involved in the pre-clinical development of a pharmaceutical formulation of growth factors to treat AMI.

Finally, TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). From June 2014, the marketing and distribution rights of ChondroCelect were exclusively licensed to Sobi for the European Union (except for Finland, where it is distributed by the Finnish Red Cross Blood Service), Norway, Russia, Switzerland and Turkey, and the countries of the Middle East and North Africa. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain).

See more at: www.tigenix.com

About BioLife Solutions

BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics 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 new products, the company's anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, and, projected financial results and liquidity. 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 products; uncertainty regarding third party market projections; market volatility; competition; litigation; 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.

Media & Investor Relations
Daphne Taylor
Senior Vice President, Chief Financial Officer
(425) 402-1400
dtaylor@biolifesolutions.com


 

 

SOURCE BioLife Solutions, Inc.



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