Antipodean Pharmaceuticals Announces FDA Acceptance of IND fo...( SAN FRANCISCO June 3 /- Antipodea...),Health

SAN FRANCISCO, June 3 /PRNewswire/ -- Antipodean Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Investigational New Drug (IND) application for its lead compound, MitoQ(R). With the IND acceptance, the Company will involve U.S. clinical centers in the development of MitoQ for the treatment of liver diseases such as non-alcoholic fatty liver disease (NAFLD).

"We look forward to working with FDA to further explore MitoQ's potential by conducting further trials in the United States," said Ken Taylor, Ph.D., Chief Executive Officer of Antipodean Pharmaceuticals. "The Company is actively seeking a pharmaceutical partner with whom to work to achieve this goal."

In April 2008, the Company announced positive results of a clinical study of MitoQ in patients with Hepatitis C virus (HCV) who had failed standard antiviral treatment. The data from this Phase 2 trial were presented at the European Association for the Study of Liver (EASL) conference. Results showed a significant reduction in elevated alanine aminotransferase (ALT) levels as compared to placebo. The ALT decrease from baseline was 26.4% (p<0.002) for patients in the 40mg dose group. This suggests that MitoQ can reduce necroinflammation and may halt disease progression to fibrosis or cirrhosis. The drug was well tolerated, with no significant safety issues.

About MitoQ(R)

MitoQ is a mitochondria-targeted antioxidant that selectively blocks mitochondrial oxidative damage and prevents liver cell apoptosis. MitoQ is based on a novel technology, targeted lipophilic cations that transport and concentrate antioxidants into the mitochondria-organelles inside cells that provide energy for life processes -- where they accumulate up to a thousand fold. MitoQ can reduce the hepatic oxidative damage that is induced by viral infection and that is also involved in the progression of Non-alcoholic Fatty Liver Disease (NA
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