Extreme Weather in Washington D.C. has Postponed the FDA’s Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010
MELBOURNE, Australia, and MENLO PARK, California USA (9 February 2010) – ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today 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.
About Omapro (omacetaxine mepesuccinate)
Omacetaxine mepesuccinate is administered subcutaneously and acts differently from TKIs. It may have a therapeutic advantage for patients who have failed TKIs. Omacetaxine is currently in global phase 2/3 clinical trials for CML and has been granted Orphan Drug designations by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMEA) as well as Fast Track status by the FDA.
Omacetaxine is a first-in-class cetaxine with demonstrated clinical activity as a single agent in a range of hematological malignancies. Omacetaxine has a novel mechanism of action, specifically binding to the ribosomal A-site cleft and inhibiting protein translation of short-lived oncoproteins that are upregulated in leukemic cells (particularly Cyclin-D1, Mcl-1 and c-Myc). In addition, pre-clinical research presented at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany this summer, demonstrated that omacetaxine kills human CML stem cells that are known to be insensitive to TKIs.
About Chronic Myeloid Leukemia (CML) and the Bcr-Abl T315I Mutation
Chronic myeloid leukemia (CML) is a cancer of the bone marrow with a worldwide prevalence of approximately 200,000 patients. The bone marrow is responsible for the production of specialized cells that constitute blood; these cells include red blood cells (to carry oxygen around the body), thrombocytes (to help stop bleeding) and certain white cells (part of the body's defense system against infection). In patients with CML the cell production system is diseased and defective. Cells multiply uncontrollably and do not fully develop (differentiate) into functional blood cells.
The majority of CML patients initially respond well to treatments with drugs called tyrosine kinase inhibitors (TKIs). However, a significant proportion of patients fail, or become intolerant to, one or more TKIs. In many of these situations the cause of failure can be traced to the emergence of Bcr-Abl mutations. A common mutation called T315I renders CML resistant to all currently approved TKIs, and has created a significant unmet medical need in the management of CML.
About ChemGenex Pharmaceuticals Limited
ChemGenex is an oncology focused biopharmaceutical company developing small molecules with new mechanisms of action to treat malignancies with significant unmet medical needs. The company is developing omacetaxine, its lead product candidate, for the treatment of patients with Chronic Myeloid Leukemia (CML), Acute Myeloid Leukemia (AML), and Myelodysplastic Syndrome (MDS). A New Drug Application has been accepted by the U.S. Food and Drug Administration and a Marketing Authorisation Application has been validated by the European Medicines Agency for CML patients with the Bcr-Abl T315I mutation. The corporate strategy for ChemGenex is to commercialize omacetaxine independently in North America and to establish commercial partnerships in the rest of the world. ChemGenex currently trades on the Australian Stock Exchange under the symbol "CXS" For additional information on ChemGenex Pharmaceuticals.
Details on the clinical trials can be accessed from the following websites:
http://www.clinicaltrials.gov and
http://www.tkiresistantcmltrials.com
Omapro is a trademark of ChemGenex Pharmaceuticals Limited
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