Vancouver, British Columbia – December 2, 2019 – Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF) (“Sirona”) announces that the first toxicology test, in preparation for the new clinical study, has been completed with positive results.
In anticipation of a clinical study in Q2 of 2020, Sirona has completed the first required toxicity study for the increased dose (0.4%) of TFC-1067. The new formulation has been tested with a “cutaneous compatibility assessment” at Cosmepar in France (https://www.cosmepar.fr/en/), which is a patch on 12 subjects for a period of 48 hrs. The test is used to determine whether the formulation is an irritant to skin. TFC-1067 .4% was found to be a non-irritant in 100% of subjects in the patch test.
In a similar study (published in the Annals of Dermatology 2017), 20 volunteers were patch-tested with varying levels of hydroquinone (HQ) alone and in combination with retinoic acid (RA). This combination is used in some skin lighteners to enhance the efficacy. Results of the study showed that HQ alone at 2% was an irritant in 30% of participants and up to 70% of participants at 4%. 4% is a dose often used in prescription level formulations, such as Tri-Luma, for melasma. In the same study, HQ combined with retinoic acid was an irritant in as many as 75% of subjects with some developing edema (inflammatory swelling of the skin). Post inflammatory responses to HQ can result in permanent discoloration to the skin.
Sirona is currently carrying out a second required tox study for TFC-1067. This study is a human repeat insult patch test (HRIPT). The HRIPT study will be 3 consecutive weeks with volunteers having repeat doses administered on a patch. Results of this study will be available early Q1 2020. Following the HRIPT, a toxicologist will examine the results for approval of the next clinical efficacy trial. Arrangements are now being made in preparation for the planned clinical trial to follow directly after the approval. We remain on target for this expedited process.
“The data we’ve received is consistent with claims that TFC-1067 is very safe at therapeutic dose. At .2% TFC-1067 was equal to HQ 2% for lightening and better than 2% hydroquinone for creating an even skin tone and we anticipate that our new dose will be more effective and quicker acting,” said Dr. Howard Verrico, CEO of Sirona Biochem. “We will not compromise on the safety of TFC-1067 as we continue to explore its full potential both in benefit to the consumer and commercial opportunity to our Sirona shareholders. It cannot be stressed enough that there is a significant unmet need for a safe alternative for people wishing to manage dark spots and create more uniform skin. There are many potentially toxic formulations available on the market that will ultimately damage the skin. Sirona Biochem will continue to strive for products that people can trust.”
The planned clinical trial is anticipated to be a value-add for the compound. Current licenses and ongoing product development by partners for TFC-1067 will not be delayed by the studies.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona’s subsidiary lab, TFChem, 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.
For more information, please visit www.sironabiochem.com.
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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.
 Increased Skin Irritation by Hydroquinone and Retinoic Acid Used in Combination https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5705352/