Vancouver, British Columbia – October 30, 2019 – Sirona Biochem Corp. TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona”) is pleased to announce that testing of the higher concentration formulation of TFC-1067, first announced in June 2019, will proceed to Human Patch Test, followed by a Human Repeat Insult Patch Test (HRIPT).
Sirona’s scientific team at TFChem and the Senior Toxicologist at CEHTRA (www.cehtra.com) have reviewed recent in-vitro safety assays and verified that the compound can be tested at double the prior concentration. This concentration was chosen as we aim to achieve maximum efficacy while maintaining TFC-1067’s excellent safety profile.
The Human Patch Test for cutaneous irritation will be conducted under physician supervision at Cosmepar (www.cosmepar.fr/en/) in France. Cosmepar’s specialized services include evaluating the tolerance of cosmetic products. The results from this test are expected within 4 weeks.
In addition, a Human Repeat Insult Patch Test (“HRIPT”) will be conducted to determine any potential irritation or sensitization issues. The HRIPT will be performed on one hundred volunteers selected by Dermscan (www.dermscan.com/en/). Results are expected in January 2020.
The higher concentration is being used in Sirona’s next generation formulation developed specifically to maximize the efficacy of TFC-1067. The formulation was developed by cosmetic expert, Gael Boutry of Global Beauty Consulting in France (www.globalbeautyconsulting.com/).
“We are excited to make this progress towards a second clinical trial of TFC-1067. The in-vitro testing has allowed us to safely double the concentration, but the in-vitro tests have their own limitations so anything over double has been deferred at this time. Safety is our priority and we will proceed to develop TFC-1067 in a stepwise approach. The new formulation is also anticipated to make a significant improvement in efficacy of TFC-1067,” said Dr. Howard Verrico, CEO of Sirona Biochem.
“A full clinical trial to assess efficacy is anticipated to begin in Q1 2020. A further update will be made prior to this trial. All testing will be done with cash on hand and will not delay any ongoing partnering discussions. TFC-1067 0.2% has already proven superior to hydroquinone 2% in creating a uniform skin tone and we anticipate even more exciting results with the new higher concentration formulation. The value of this benefit to the consumer and ultimately for our shareholders cannot be underestimated and will improve the commercial value for our shareholders,” added Dr. Verrico.
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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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.