Dr. Howard Verrico reports
SIRONA BIOCHEM RECEIVES POSITIVE SAFETY DATA FOR LEAD SKIN-LIGHTENER IN PREPARATION FOR CLINICAL TRIAL IN THE US
Sirona Biochem Corp. has provided an update on further progress regarding the clinical development of its lead skin lightener, TFC-1067.
In parallel with continuing partnering discussions, Sirona has completed steps toward the clinical trial for TFC-1067. A toxicologist from CEHTRA in Paris was hired to approve Sirona's compound for clinical use. From the preclinical data, the toxicologist established a clinical dose for the compound and further confirmed that it does not degrade into toxic metabolites such as hydroquinone and benzoquinone.
The company also contracted formulation expert Gael Boutry of Global Beauty Consulting in France to develop a formulation acceptable for clinical use. The formulation (face cream) containing TFC-1067 has already been prepared, packaged and tested in an accelerated stability test to ensure shelf life.
Over the past two months, safety studies with the formulation have been continuing at Dermscan, Poland, and continue to provide positive data for TFC-1067. The first study, a human patch test on 10 people, confirmed TFC-1067 as a non-irritant, in contrast to many other skin lighteners.
In early August, a second clinical trial for the human repeat insult patch test (HRIPT), which assesses sensitization on a larger group (110 people), began, in preparation for future efficacy trials. Initial results from the panel show TFC-1067 as a non-sensitizer. With these tests completed, Sirona will begin its proof-of-efficacy clinical trial in October at a centre in the United States, which will be led by an acclaimed dermatologist.
"The significance of the data that supports the formulated TFC-1067 cream as a non-irritant, non-sensitizer cannot be understated as many common skin lighteners, like hydroquinone, resorcinol and kojic acid, have known toxicities at effective doses," said Dr. Howard Verrico, chief executive officer of Sirona Biochem. "The market has an unmet need with the safety and efficacy problems associated with the currently available skin lighteners, and we are confident that TFC-1067 will meet this need. With an inventory of formulated product, we are primed to start the trial in October."
The planned clinical trial does not prevent negotiations of a definitive agreement in the interim. Advancing the development continues to add value to TFC-1067 and shorten the time to full commercialization. This improves Sirona's future potential partners' ability to share the company's confidence in the commercial opportunity the company is creating. In parallel, meetings with North American and Asian cosmetic companies continue to move forward.
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.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and continuing royalty payments.
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