Mr. Christopher Hopton reports
SIRONA BIOCHEM BEGINS PROOF OF EFFICACY CLINICAL TRIAL FOR TFC-1067
Sirona Biochem Corp. has launched the clinical trial for skin-lightener TFC-1067 with leading dermatologist Dr. Zoe Draelos.
In September, Sirona reported that the company was awaiting final results from the second clinical trial for the Human Repeat Insult Patch Test (HRIPT). This test was performed on 110 people to assess safety of TFC-1067. The data confirmed TFC-1067 as a non-sensitizer, providing the final support needed for toxicologist approval.
Following completion of the preliminary studies and toxicologist approval, the company has begun the enrolment process for the clinical trial. All material, including the formulated TFC-1067 cream, has been delivered to the clinical trial centre in North Carolina and final International Review Board approval is pending.
Once patients have been enrolled, the 12-week assessment of TFC-1067 will begin under the supervision of Dr. Draelos, who has conducted clinical trials for many top pharmaceutical companies worldwide. The company looks forward to using the results to further and solidify discussions with partners in North America and Asia, as final confirmation of TFC-1067's safety and efficacy as a skin-lightening agent.
"This clinical trial marks a major milestone for Sirona Biochem and its scientific team," said Dr. Howard Verrico. "With the anticipated start of the clinical trial for Sirona's SGLT-2 inhibitor, TFC-039, by partner Wanbang Biopharmaceuticals Co. Ltd. this year, we will have two compounds simultaneously in clinical trials. This highlights the strength of Sirona's platform technology in creating novel compounds for both therapeutic and cosmetic indications with excellent potential for full commercialization."
About Dr. Zoe Draelos
Dr. Draelos is a clinical and research dermatologist based in High Point, N.C. Dr. Draelos, supported by a team of highly skilled scientists, is the head of the Dermatology Consulting Services (DCS) research organization, aimed at facilitating research, consulting and communication services to the pharmaceutical and cosmetic industries. The clinical trial centre runs assessments on different skin, hair and nail conditions, such as acne, psoriasis, hair loss and aging.
With over 30 years of experience, Dr. Draelos has been recognized many times over the years for her cutting-edge research, including the lifetime achievement award from Health Beauty America and the Society of Cosmetic Chemists. A pioneer in the field of cosmetic dermatology, Dr. Draelos continues to work with lead cosmetic and pharmaceutical companies, as well as furthering her own research in the dermatology space.
Dr. Draelos was a past vice-president of the American Academy of Dermatology and is a consulting professor of dermatology at Duke University. She has authored over 300 articles, eight books and has shared her expertise across different media.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona Biochem specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety.
Sirona Biochem's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and continuing royalty payments. Sirona Biochem's laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards, as well as European Union and French government grants.
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