Antipodean Pharmaceuticals Announces FDA Acceptance of IND for MitoQ(R)

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Antipodean Pharmaceuticals Announces FDA Acceptance of IND for MitoQ(R)

Thursday, 05 June 2008 23:27

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

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

In April 2008, the Company announced positive results of a clinical studyof MitoQ in patients with Hepatitis C virus (HCV) who had failed standardantiviral treatment. The data from this Phase 2 trial were presented at theEuropean Association for the Study of Liver (EASL) conference. Results showeda significant reduction in elevated alanine aminotransferase (ALT) levels ascompared to placebo. The ALT decrease from baseline was 26.4% (p<0.002) forpatients in the 40mg dose group. This suggests that MitoQ can reducenecroinflammation 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 blocksmitochondrial oxidative damage and prevents liver cell apoptosis. MitoQ isbased on a novel technology, targeted lipophilic cations that transport andconcentrate antioxidants into the mitochondria-organelles inside cells thatprovide energy for life processes -- where they accumulate up to a thousandfold. MitoQ can reduce the hepatic oxidative damage that is induced by viralinfection and that is also involved in the progression of Non-alcoholic FattyLiver Disease (NAFLD) through to Non-alcoholic Steatohepatitis (NASH), leadingto fibrosis or cirrhosis.

About Non-alcoholic Fatty Liver Disease (NAFLD)

Symptoms of NAFLD include fat deposits, inflammation of the liver, andelevated liver enzymes -- ALT and AST. As with Hepatitis C, oxidative stressis involved in NAFLD disease progression to fibrosis and cirrhosis. NAFLDaffects approximately 20% of the world's population and the incidence isgrowing rapidly as obesity rates rise. There are currently no satisfactorytreatment options.

About Antipodean

Antipodean is a clinical-stage pharmaceutical company developing targetedmolecules that prevent oxidative damage to endothelial, epithelial and livercells leading to apoptosis and fibrosis. The Company is developing amitochondria-targeted antioxidant, MitoQ (mitoquinone mesylate), for thetreatment of hepatic inflammatory disorders caused by oxidative stress such asNAFLD and NASH. The Company's business plan is to develop drugs to the pointof proof of principle and then partner further development. Antipodean hasresearch collaborations with pre-clinical and clinical investigators inCambridge, UK, Auckland, New Zealand, and several centers in the US toidentify and develop lead compounds through to clinical proof-of-principle.Currently the Company's lead compounds target liver and skin diseases.Antipodean is located in San Francisco, California. Further information isavailable at http://www.antipodeanpharma.com

SOURCE Antipodean Pharmaceuticals, Inc.

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