Vancouver, British Columbia – March 20, 2013 – Sirona Biochem Corp. (TSX-V: SBM, OTCQX: SRBCF, Frankfurt: ZSB), announced today it has successfully completed the set of industry-standard cosmetic safety tests for both skin lightening compounds, TFC-849 and TFC-723. The final two safety tests studied phototoxicity and skin irritation in accordance with the regulatory methods of the European Centre for the Validation of Alternative Methods (ECVAM) and the Organization for Economic Co-operation and Development (OECD). The successful completion of the safety tests for both compounds means that Sirona Biochem will be releasing two skin lightening compounds for national, multi-national and global licensing agreements.
The phototoxic potential of TFC-849 and TFC-723 was evaluated at a concentration range 0 to 1000 µg/ml for 1 hr on fibroblast cultures, exposed to the highest non-cytotoxic UVA irradiation dose (5 J/cm²). Fibroblasts’ viability was assessed using the neutral red uptake method and compared in both irradiated and non-irradiated cultures. Neither compound (TFC-849 or TFC-723) showed phototoxicity in the concentration range tested.
The irritant potential of TFC-849 and TFC-723 was evaluated on reconstituted human epithelium (RHE) at concentrations 0.5%, 2.5% and 5% (w/v). The RHE viability was assessed using an MTT assay and both depigmenting agents, TFC-849 and TFC-723, showed no skin irritation in the concentration range studied.
“Having both TFC-849 and TFC-723 successfully complete all safety testing is a testament to our scientists and patented technology. Safe and effective skin lightening agents are at a premium in the lucrative cosmetic and dermatologic industries and we have two leading compounds. I’m extremely proud of our team,” said Neil Belenkie, Chief Executive Officer of Sirona Biochem.
It is estimated that more than $7.5 billion was spent on cosmetic skin lighteners in 2009 and that number is expected to exceed $10 billion by 2015. Approximately 15% of the worldwide population invests in skin lightening products with Asia being the largest market. For dermatologists, medical conditions such as hyperpigmentation, melasma, vitiligo and rosacea are also contributing to the demand for safer and more effective skin lightening creams.
No animals were involved in the development and testing of Sirona’s skin lightening compounds.
About the Project
Sirona Biochem’s French subsidiary, TFChem received in November 2011 a $1.9-million grant. This project is co-financed by the European Union and Europe Witnesses in Haute-Normandie with the support of the European Regional Development Fund (E.R.D.F.). A consortium of partners – including the University of Rouen (LMSM EA4312), contract research organization Biogalenys, and TFChem – has been assembled to advance this project. The French government and European Union are looking to promote and initiate collaborative projects that are focused on the development of new products and services containing a high level of innovation.
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