Vancouver, British Columbia – November 6, 2018 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (the “Company”) reported today the successful launch of 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 enrollment process for the clinical trial. All material, including the formulated TFC-1067 cream, has been delivered to the clinical-trial center in North Carolina and final International Review Board approval is pending.
Once patients have been enrolled, the twelve-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. Zoe Draelos is a clinical and research dermatologist based in High Point, North Carolina. 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 center runs assessments on different skin, hair and nail conditions, such as acne, psoriasis, hair loss and aging.
With over thirty 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, 8 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 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 located 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.