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Sirona Biochem Receives Positive Safety Data for Lead Skin-Lightener in Preparation for Clinical Trial in the US
VANCOUVER, British Columbia , Sept. 26, 2018 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (Xetra: ZSB) (the “Company”) is pleased to report further progress regarding the clinical development of its lead skin-lightener, TFC-1067.
In parallel with ongoing partnering discussions, Sirona has completed steps toward the clinical trial for TFC-1067. A toxicologist, from CEHTRA in Paris, was hired to approve Sirona’s compound for clinical use. From the pre-clinical data, the toxicologist established a clinical dose for the compound and further confirmed that it does not degrade into toxic metabolites such as hydroquinone and benzoquinone.
The Company also contracted formulation expert Gael Boutry of Global Beauty Consulting in France to develop a formulation acceptable for clinical use. The formulation (face cream) containing TFC-1067 has already been prepared, packaged and tested in an accelerated stability test to ensure shelf-life.
Over the past two months, safety studies with the formulation have been ongoing at Dermscan, Poland, and continue to provide positive data for TFC-1067. The first study, a human patch test on 10 people, confirmed TFC-1067 as a non-irritant, in contrast to many other skin-lighteners.
In early August, a second clinical trial for the Human Repeat Insult Patch Test (HRIPT) which assesses sensitization on a larger group (110 people) began, in preparation for future efficacy trials. Initial results from the panel show TFC-1067 as a non-sensitizer. With these tests completed, Sirona will begin their proof of efficacy clinical trial in October, at a center in the United States, led by an acclaimed dermatologist.
“The significance of the data that supports the formulated TFC-1067 cream as a non-irritant, non-sensitizer cannot be understated, as many common skin-lighteners, like hydroquinone, resorcinol, and Kojic Acid, have known toxicities at effective doses,” said Dr. Howard Verrico, CEO of Sirona Biochem. “The market has an unmet need with the safety and efficacy problems associated with the currently available skin lighteners and we are confident that TFC-1067 will meet this need. With an inventory of formulated product, we are primed to start the trial in October.”
The planned clinical trial does not prevent negotiations of a definitive agreement in the interim. Advancing the development continues to add value to TFC-1067 and shorten the time to full commercialization. This improves our future potential partners ability to share our confidence in the commercial opportunity we are creating. In parallel, meetings with North American and Asian cosmetic companies continue to move forward.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com.
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For more information regarding this press release, please contact:
Christopher Hopton, CFO
Sirona Biochem Corp.
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.