This excerpt taken from the MDVN 8-K filed May 11, 2006.
MEDIVATION PROVIDES UPDATE ON HUNTINGTONS DISEASE IND
SAN FRANCISCO (May 10, 2006) Medivation, Inc. (AMEX: MDV) today announced that on May 8, 2006 it received a letter from the U.S. Food and Drug Administration (FDA) regarding its investigational new drug (IND) application to begin human testing of Dimebon for Huntingtons disease. The letter confirmed the information initially communicated by the FDA in a February 28, 2006 telephone call that additional rat toxicology data are required before human clinical trials can begin. The FDA expressed the concern that the dose levels of Dimebon used in one of Medivations rat toxicology studies did not result in sufficient toxicity to define a maximum tolerated dose. This information might provide additional guidance to physicians regarding the potential toxicities of Dimebon in humans.
To address the FDAs concern, in March 2006 Medivation initiated additional rat toxicology studies to evaluate Dimebon at higher doses than those used in the prior study. Medivation expects to have sufficient data in the third quarter of 2006 to request the FDA to allow initiation of the proposed Phase 1-2a clinical study of Dimebon in patients with Huntingtons disease.