BioLife Solutions HypoThermosol® Embedded in Two Intercytex Clinical Trials of Cell-Based Wound Care Proprietary Dermal Fibroblast-Based Product in HypoThermosol Could Greatly Improve Treatment of a Debilitating Skin Condition and also Burn Injuries
BOTHELL, Wash., Aug. 22, 2013 /PRNewswire/ -- BioLife Solutions, Inc. (OTCQB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced that its HypoThermosol, a pre-formulated, cGMP, serum-free, protein-free cell and tissue storage/shipping medium, is currently incorporated into on-going US and European clinical trials of ICX-RHY-013, a proprietary cell-based therapy developed by Intercytex Ltd. In both clinical trials, HypoThermosol is the vehicle solution containing the therapeutic cells administered to the patients, and is also the placebo solution in a control arm of the studies.
Mike Rice, BioLife Solutions President and CEO, commented on the use of HypoThermosol in these clinical trials by stating, "We are quite pleased to support Intercytex in their very important work to develop improved treatments for burn injuries and recessive dystrophic epidermolysis bullosa (RDEB), an extremely debilitating skin and internal tissue disorder affecting children and adults.
The US phase 1/2 clinical trial (NCT01564407), titled A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures, is being conducted at the University of Pittsburgh Medical Center and is funded by the United States Department of Defense. The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment of stable, restrictive scars in subjects who have suffered a burn injury.
Also, data from a phase 2, double-blind, randomized, vehicle-controlled European clinical trial (EudraCT Number: 2010-023121-38), titled A prospective placebo controlled phase II study to evaluate the use of allogeneic fibroblasts for the treatment of skin erosions in recessive dystrophic epidermolysis bulllosa, appears on page 28 in the online directory of abstracts presented at the 2013 International Investigative Dermatology meeting, held in Edinburgh, Scotland in May of this year.
The abstract, titled Allogeneic fibroblast cell therapy accelerates wound healing in recessive dystrophic epidermolysis bullosa (RDEB), follows in italic text;
Fibroblast cell therapy can modify disease biology in RDEB although its impact on wound healing is not clear. We compared allogeneic fibroblasts (ICX-RHY-013; sterile suspension of 20x106 per ml of allogeneic human dermal fibroblasts in HypoThermosol®-FRS vehicle) injected intradermally into erosion margins of individuals with RDEB, with injections of vehicle only, to assess safety and efficacy.
Erosions were randomised in a computer-generated block 1:1 ratio, to either a single treatment of 5x106 fibroblasts per linear cm of erosion margin or to a similar volume per linear cm of erosion margin of vehicle. All subjects continued standard wound care.
The trial sponsor, statistician, participants and the investigator conducting the study assessments and follow up visits were masked to treatment allocation.
The main endpoint was mean area change in treated erosions at the end of 6 months.
Analyses were by intention to treat. 26 erosions in 11 RDEB subjects were injected; 14 erosions received ICX-RHY-013 and 12 vehicle alone.
All follow-up visits were completed for each case. Percentage erosion area decreased rapidly after active treatment.
Treatment difference between ICX-RHY-013 and vehicle was -23.5% (CI -3.5 to-43.5, p=0.025) at day 7, -19.15% (CI 3.36 to -41.66, p=0.089) at day 14 and -28.83% (CI 7.97 to -65.63, p=0.11) at day 28.
Beyond day 28, however, changes in mean erosion area did not differ significantly between the two groups, although blinded independent assessment of photographs showed that 78.6% and 92.8% of the erosions treated with ICXRHY-013 were clinically better from baseline at 28 days and 6 months, respectively.
Intradermal injections of allogeneic fibroblasts increase the rate of erosion healing in subjects with RDEB within the first 28 days although further studies will be needed to address optimal cell dosage and frequency of re-treatment.
About Intercytex, Ltd.
Intercytex Ltd. is a UK Regenerative Medicine product and services company re-launched in Nov 2010. The Company is focused on developing its lead product ICX-RHY (VAVELTA) to treat a variety of skin related problems including Epidermolysis Bullosa and scar contractures as well as providing its Cell2Therapy Translation service to other Regenerative Medicine based companies and Research Groups, in order to enable them to take their cell therapy rapidly into the clinic. For more information please visit www.intercytex.com.
About BioLife Solutions
BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions for cells, tissues, and organs. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's 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 academic and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs. BioLife Solutions is certified to ISO13485:2003. 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.
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