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Extreme Weather In Washington D.C. Has Postponed The FDA’s Oncologic Drugs Advisory Committee Meeting Scheduled For 10 February 2010


ChemGenex Pharmaceuticals Limited (ASX:CXS) announced that the U.S. Food and Drug Administration (FDA) has notified the company that the Oncologic Drugs Advisory Committee (ODAC) public advisory meeting scheduled for 10 February 2010 has been suspended due to extreme weather conditions in Washington D.C.

The ODAC meeting was scheduled to review two New Drug Applications, one of which was the application submitted by ChemGenex for OMAPRO™ (omacetaxine mepesuccinate) for the treatment of adults with chronic myeloid leukemia (CML) who have failed prior therapy with imatinib and who have developed the Bcr-Abl T315I mutation. ChemGenex submitted the NDA on 9 September 2009. The NDA was accepted by the FDA on 10 November 2009 and granted Priority Review.

The FDA will notify the company of a new date for the meeting as soon as possible.

ChemGenex believes in the safety and efficacy of OMAPRO™ for the treatment of patients with chronic myeloid leukemia (CML) who are resistant to imatinib and have the Bcr-Abl T315I mutation. The company is aware of the questions posed by the FDA and we are confident in our ability to answer these questions during the ODAC meeting. OMAPRO addresses a significant unmet need for patients with the T315I mutation, a marker for resistance to tyrosine kinase inhibitors, who currently have no effective treatment option and often have a poor prognosis.


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