Vancouver, British Columbia – May 15, 2019 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (“Sirona”) is pleased to announce results of a clinical trial performed in the Peoples Republic of China (China) using Sirona’s novel skin lightening agent TFC-1067. Sirona’s TFC-1067 once again demonstrated significant clinical lightening effect without any reported adverse effects.
A major distributor of cosmetics materials in China arranged clinical testing of TFC-1067 to be done by a select group of its key cosmetic customers. The formulation used in the studies was the same as that used in Sirona’s first clinical trial in the USA by Dr. Zoe Draelos. The clinical trial design protocols and the testing was conducted independently of Sirona by the cosmetic companies. The studies were conducted in Guangzhou, China.
A total of 60 participants were involved in the studies conducted over several sites. All participants applied the formulation with TFC-1067 twice daily to the face. Each study duration was 4 weeks. During the 4 weeks 90% of participant reported a brightening effect with TFC-1067. Sirona is informed by the distributor that a second set of trials with Sirona’s improved, next generation, formulation is underway.
Dr. Géraldine Deliencourt-Godefroy, Chief Scientific Officer of Sirona Biochem stated, “These are excellent clinical results. Based on the outcome from our first clinical trial, we are pleased to see such results for the short 4-week duration of the testing. This positive testing result on Asian skin with the observed lightening effect supports the clinical effect of TFC-1067 over different skin types. A longer trial is required to assess dyschromia which was assessed in Sirona’s US based clinical trial. Sirona will await feedback on the further testing currently ongoing in China with our new formulation.”
“No clinical safety issues were reported with TFC-1067 during the trial. TFC-1067 has shown a lightening effect over a short clinical trial on Asian skin types.” reports Dr. Howard Verrico, CEO of Sirona Biochem. “Although we prefer to conduct trials with a double blinded protocol using a comparative compound and a longer trial duration as we arranged in the USA, it was important to have these cosmetic companies perform their own clinical testing independently and be confident of the results. TFC-1067 continues to deliver excellent clinical results as anticipated by our preclinical assays. A strong commercial interest in TFC-1067 is already reported by the distributor based on current results.”
“Sirona’s team remains dedicated to work towards entering this market with a safe and effective alternative to current options. We are moving forward on building our relationship with the Chinese distributor with more positive news anticipated near term”, Dr. Verrico concluded.
The global skin lightening market is estimated to grow to US$31.2 billion by 2024. Asia makes up the largest and fastest growing segment of the market. A World Health Organization survey reported that nearly 40 per cent of women polled in China said they regularly used whitening products many of which are toxic.
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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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.