Compounds TFC-849 and TFC-723 were tested in a skin sensitization risk assessment, which is an important component of the safety assessment of cosmeceuticals. Sensitization testing measures whether the repeated application of a compound will produce an allergic reaction or immunotoxicity to the skin.
Sirona Biochem conducted its study using a multi-parameter in vitro alternative method developed by the LMSM at the University of Rouen because no in vitro alternative method of testing has been adopted yet by EURL ECVAM (European Union Reference Laboratory for Alternatives to Animal Testing). In the study, the compounds' sensitizer potency was evaluated using a combination of 4 parameters (resorption, haptenation, IL-18 production and cytotoxicity) and a decision table to analyze the compiled results.
Both compounds, TFC-849 and TFC-723, were proven to be non-sensitizers. The study, part of the BetaClear project, funded by a $1.9 million French grant, is led by TFChem, Sirona Biochem's subsidiary, and involves a consortium of partners.
"We are thrilled to be developing a track record of continued positive results in the testing of our compounds, with the newest results showing that our compounds are non-sensitizers," said Neil Belenkie, Chief Executive Officer of Sirona Biochem. "The support of our partners has been essential in the testing of our compounds, and we look forward to the development of a world-class skin lightening product," he added.
According to Global Industry Analysts, the global skin lightening market is estimated to be US$9 billion and is expected to exceed US$19.8 billion by 2018. Fairness products account for over 45 percent of the skincare market and it's estimated that about 15 percent of the global population invests in skin lightening products. Japan has the largest market worldwide for skin lightening, and Asia-Pacific is led by India and China as the fastest growing skin lightening market in the world.
About Sirona Biochem Corp.
Sirona Biochem is a biotechnology company developing diabetes therapeutics, cancer vaccine antigens, skin depigmenting and anti-aging agents for cosmetic use, and biological ingredients. The company utilizes a proprietary chemistry technique to improve pharmaceutical properties of carbohydrate-based molecules. For more information, visit www.sironabiochem.com.
About the Project
Sirona Biochem's French subsidiary TFChem, received a $1.9 million grant in November 2011. This project is co-financed by the European Union and Europe Witnesses in Haute-Normandie with the support of the European Regional Development Fund (E.R.D.F.). A consortium of partners, including the University of Rouen (LMSM EA4312), contract research organization Biogalenys, and TFChem, has been assembled to advance this project. The French government and European Union are looking to promote and initiate collaborative projects that are focused on the development of new products and services containing a high level of innovation.
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Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
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