VANCOUVER, British Columbia, Nov. 16, 2022 (GLOBE NEWSWIRE) -- Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) ("Sirona") is pleased to announce positive results of the clinical safety study for their novel anti-aging compound TFC-1326 1% in formulation, now proven to be a non-irritant and non-sensitizer. TFC-1326, Sirona's lead anti-aging compound, will soon enter a clinical trial designed to assess its potential to reverse the effects of aging on facial skin, restoring lost volume and reducing fine wrinkles.
The safety study, which was conducted in Europe under the control of a dermatologist, is a Human Repeat Insult Patch Test with Challenge (HRIPT). The main goal of the HRIPT is to confirm that the application of the investigational product (under maximizing conditions of exposure in a panel of healthy human adult subjects) does not induce delayed contact sensitization and secondarily, to assess the skin compatibility of the formulation. TFC-1326 1% in formulation is a non-irritant and non-sensitizer, a claim recognized in the industry based on these results and accepted by global regulatory bodies.
The study population included 100 healthy individuals aged 18-70. Applications were repeated 9-times to the same site (induction site) over a period of 3 consecutive weeks. After a minimal 2-week rest period, with no product application, a single application of the investigational product was placed under a patch to both the induction site and a new site, to reveal a possible induced allergy (challenge phase). In parallel, distilled water is placed under a patch at the same defined times as the investigational product to act as a control site.
Sirona's anti-aging compound at 1% in the formulation did not cause irritation, sensitization or allergy in any subject.
The results of the HRIPT study are necessary to move to the efficacy clinical trial which remains scheduled to start in early December. A news release will be made announcing the start of the trial and further details will be provided.
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.
