Extreme Weather in Washington D.C. has Postponed the FDA’s Oncologic Drugs Advisory Committee Meeting Scheduled for 10 Febr...
09 February 2010 - 12:01PM
Business Wire
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 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. 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 who
have failed imatinib therapy and have the Bcr-Abl T315I mutation.
ChemGenex has established a corporate alliance with Hospira to
develop and commercialize omacetaxine in Europe, the Middle East
and parts of Africa, and is seeking to establish commercial
partnerships in the rest of the world. ChemGenex plans to
commercialize omacetaxine itself in North America. ChemGenex trades
on the Australian Stock Exchange under the symbol "CXS" For
additional information on ChemGenex Pharmaceuticals, please visit
the company’s website at http://www.chemgenex.com.
OMAPRO™ is a trademark of ChemGenex Pharmaceuticals Limited.
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“estimate”, “project”, “intend”, “expect”, “believe” and similar
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Act of 1995. These forward-looking statements involve known and
unknown risks and uncertainties which could cause the actual
results, performance or achievements of the company to be
materially different from those which may be expressed or implied
by such statements, including, among others, risks or uncertainties
associated with the development of the company’s technology, the
ability to successfully market products in the clinical pipeline,
the ability to advance promising therapeutics through clinical
trials, the ability to establish our fully integrated technologies,
the ability to enter into additional collaborations and strategic
alliances and expand current collaborations and obtain milestone
payments, the suitability of internally discovered genes for drug
development, the ability of the company to meet its financial
requirements, the ability of the company to protect its proprietary
technology, potential limitations on the company’s technology, the
market for the company’s products, government regulation in
Australia and the United States, changes in tax and other laws,
changes in competition and the loss of key personnel. These
statements are based on our management’s current expectations and
are subject to a number of uncertainties that could change the
results described in the forward-looking statements. Investors
should be aware that there are no assurances that results will not
differ from those projected.
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