Mitotech S.A. initiated its IND program in the U.S. Aim of the IND program is to repeat animal safety studies of Mitotech's first drug Visomitin at independent U.S. laboratories and to seek IND approval for Visomitin with the FDA in late 2013.
"Mitotech has performed a variety of safety and efficacy studies involving Visomitin and its active component SkQ1 up to this date, said Natalia Perekhvatova, Chief Executive Officer of Mitotech S.A. “This new preclinical program is designed as a formal IND study program with an aim to submit a formal IND application for SkQ1-based ophthalmic drug in 2013 and then make another application for a systemic IND in 2014-2015 timeframe.”
About Mitotech S.A
Mitotech S.A. is a Luxembourg-based biotechnology company developing novel drugs for the treatment of age-related disorders. Mitotech S.A. was founded as a spinoff from the bioengineering department of the Moscow State University. The core technology behind Mitotech products is based on the world-renowned work by Professor Vladimir Skulachev in designing mitochondrially addressed antioxidants. Company's lead compound SkQ1 is being developed into several drugs covering a variety of therapeutic areas and methods of administration.