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 (https://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 (https://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.
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