The TFC-849 and TFC-723 compounds were proven to be non-genotoxic in an industry standard genotoxicity study, as they were evaluated at a concentration range of 0-5 percent using a standard bacterial colorimetric assay.
Genotoxicity testing measures DNA degradation, which can be evidence of potential mutagenicity or carcinogenicity.
Sirona’s compounds were shown to not release hydroquinone, a concern of currently marketed skin lighteners due to links to cancer, and is also banned in Europe and restricted in the US.
“It is our goal to develop a safe and effective skin lightening compound for cosmetic use. Today we have taken a major step towards this goal,” comments company CEO Neil Belenkie.
“The genotoxicity results demonstrate further evidence of the strong safety profile of our skin lightening compounds, TFC-849 and TFC-723.”
Safe and effective
In addition to the safety results, Sirona’s compounds were also shown, in previous studies, to be more effective and stable than alpha- and beta arbutin; two of the world's top skin lighteners.
“To have these safety results plus high effectiveness puts us in a strong position to enter the skin lightening market,” continues Belenkie.
“We believe we have developed skin lightening compounds that are both safe and effective, meeting an unmet demand for the multi-billion dollar skin lightening marketplace,” he adds.
The skin lightening market is growing rapidly. In Japan alone, approximately 55 percent of women use skin lightening products.
Sales are expected to be $10 billion by 2015, driven by new markets in the West and sustained growth in Asia-Pacific, according to Global Industry Analysts (GIA).
Sirona Biochem’s French subsidiary, TFChem has been charged with developing this area of the biotechnology company, having received a $1.9-million grant in November 2011.
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.