Dr. Howard Verrico reports

SIRONA BIOCHEM REPORTS 100% SAFETY IN FIRST TOX STUDY FOR INCREASED CONCENTRATION OF TFC-1067

The first toxicology test, in preparation for Sirona Biochem Corp.'s 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 per cent) of TFC-1067. The new formulation has been tested with a cutaneous compatibility assessment at Cosmepar in France, which is a patch on 12 subjects for a period of 48 hours. The test is used to determine whether the formulation is an irritant to skin. TFC-1067 0.4 per cent was found to be a non-irritant in 100 per cent of subjects in the patch test.

In a similar study (1) (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 per cent was an irritant in 30 per cent of participants and up to 70 per cent of participants at 4 per cent. Four per cent is a dose often used in prescription level formulations, such as Tri-Luma2, for melasma. In the same study, HQ combined with retinoic acid was an irritant in as many as 75 per cent of subjects with some developing edema (inflammatory swelling of the skin). Postinflammatory 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 three 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. The company remains 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 0.2 per cent TFC-1067 was equal to HQ 2 per cent for lightening and better than 2 per cent 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, chief executive officer 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 licences and continuing product development by partners for TFC-1067 will not be delayed by the studies.

(1) Increased Skin Irritation by Hydroquinone and Retinoic Acid Used in Combination.

(2) Tri-Luma.

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.

We seek Safe Harbor.