Vancouver, British Columbia – June 11, 2019 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (“Sirona”) is pleased to announce that it will assess its novel skin lightener, TFC-1067, at a concentration 3 times higher than what was used in the previous clinical trial. Higher dosing is expected to have increased efficacy, but also the potential to work more quickly than the clinically effective dose established for TFC-1067. This positive development is of substantial commercial interest to potential cosmetic partners in North America and China who share Sirona's goal to maximize efficacy without compromising safety.
Previous maximum dosing levels were limited due to technical issues with the standard regulatory in vitro test used to assess TFC-1067 for skin irritation. A solution to these technical issues has been developed. Sirona’s consultant safety assessor at CEHTRA (www.cehtra.com) has now recommended further testing with up to a 3 times higher dose. Several higher doses will be assessed by Idea Lab (www.ideatestsgroup.com), experts in safety testing of cosmetics. If the in vitro results of the higher concentrations continue to show no evidence for skin irritation, Sirona will proceed to preparation for clinical testing on humans.
“The clinical effect of TFC-1067 to lessen dark spots or have an overall brightening effect is largely dose dependent”, reports Dr. Howard Verrico, CEO of Sirona Biochem. “We anticipate TFC-1067 will be used at higher doses without adverse effects. While we are pleased with the excellent clinical results achieved so far, being able to test at significantly higher concentrations will likely lead to better clinical effectiveness, potentially faster results and a better range of consumer dosing options.”
“We knew the standard regulatory tests prevented us from utilizing the full potential of TFC-1067 as a skin lightener. We anticipate we will proceed in the future to test our improved formulation combined with higher concentrations of TFC-1067 in further clinical trials. Such testing can be conducted either independently by Sirona or through our anticipated partnerships”, Dr. Verrico added.
The global skin lightening market is expected to reach US$31.2 Billion by 2024.
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 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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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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