Vancouver, British Columbia – April 10, 2019 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (the “Company”) is pleased to announce the results of its clinical trial performed by Dr. Zoe Draelos of Dermatology Consulting Services, conducted in North Carolina, USA. Sirona’s TFC-1067 demonstrates superiority to the gold standard, hydroquinone, for the treatment of dyschromia (hyperpigmentation or “dark spots” of the skin).
In the 12-week double blinded study involving 48 participants, TFC-1067 successfully achieved the endpoint of lightening dyschromic areas on the skin. With application of TFC-1067, areas of hyperpigmentation were significantly lightened and blended into surrounding skin, evening skin tone while preserving overall tone. TFC-1067, achieved this goal, while the hydroquinone comparator did not.
No clinical safety issues were observed with TFC-1067 during the trial. Combined with extensive preclinical safety testing, there is now strong evidence that TFC-1067 is a safe and superior replacement to hydroquinone for the treatment of facial hyperpigmentation.
Hydroquinone has remained the gold standard for skin lightening despite known toxicity which is an ongoing concern for the FDA and the dermatology community. Hydroquinone is banned or has restricted dosing in an increasing number of countries. Although many non-hydroquinone alternative lightening compounds are either toxic or ineffective, unfortunately, millions of people still resort to toxic treatments for hyperpigmentation despite poor aesthetic results. There is a clear unmet need for a safe and effective treatments in this 20-Billion-USD skin lightening market.
The Company is currently pursuing publication of these results in a peer reviewed scientific journal. A detailed report of the clinical trial will then be made available to the scientific community including the dermatological and cosmetic community.
“Having demonstrated clinically in our human trial what we predicted in preclinical testing is further validation of the commercial value of our proprietary technology”, reports Dr. Howard Verrico, CEO Sirona Biochem. “These results were achieved with a very basic formulation. The full potential of TFC-1067 is yet to be demonstrated. Having validated the commercial value of TFC-1067 with the clinical trial’s success we have greatly improved our licensing opportunities and value globally. Currently we are in discussions for licensing TFC-1067 in specific markets. An update will be released when these discussions conclude.”
“TFC-1067 performed remarkably well in comparison to 2% hydroquinone, which traditionally has been challenging to approximate. Hydroquinone alternatives are needed”, said Dr. Zoe Draelos. “Most consumers desire lightening of dark spots to blend into surrounding skin. The study product achieved this goal.”
About Dr. Zoe Draelos
Zoe Diana Draelos, MD, is a practicing board-certified dermatologist and a Fellow of the American Academy of Dermatology with a research interest in cosmetics, toiletries, and biologically active skin medications. She is a researcher in High Point, North Carolina, and a Consulting Professor of Dermatology at Duke University. In 1988, she founded Dermatology Consulting Services to provide education, develop formulations, and conduct clinical studies in association with industry. Prior to pursuing a medical career, Dr. Draelos completed an undergraduate degree in Mechanical Engineering and was elected a Rhodes Scholar. A member of Sigma Xi research honorary and Alpha Omega Alpha medical honorary, she is author of 12 textbooks, including Cosmetics in Dermatology, now in its second edition after having been translated into 4 languages, Hair Cosmetics, as well as the editor of Cosmeceuticals, now in its third edition and translated into 5 languages. She has experience conducting FDA phase I, II, III, and IV studies and also specializes in OTC drug and cosmetic studies. Dermatology Consulting Services can develop protocols, write consents, organize case report forms, obtain IRB approval, recruit and administer the study, perform data entry, prepare the statistical analysis, and write the final report. She has successfully completed over 545 clinical studies as the primary investigator. This diversity of services offered by Dr. Draelos provides a unique start to finish approach to clinical research for drugs, OTC drugs, and cosmetic formulations.
For further information, please visit http://www.zoedraelos.com/.
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.
 Fact.MR (July 2018) Retrieved from: https://globenewswire.com/news-release/2018/07/10/1535161/0/en/Key-Insights-on-Skin-Lightening-Products-Market-through-2022-by-Fact-MR.html