MELBOURNE, Australia & MENLO PARK, Calif.--(Business Wire)--
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that the U.S. Food &
Drug Administration (FDA) has accepted the company`s New Drug Application (NDA)
for Omapro (omacetaxine mepesuccinate) for the treatment of patients with
chronic myeloid leukemia (CML) who have failed treatment with imatinib and who
have developed the Bcr-Abl T315I mutation. The NDA has also been granted
Priority Review. A Priority Review designation is given to drugs that offer
major advances in treatment or provide a treatment where no adequate therapy
exists, and generally denotes that the FDA review period is reduced to
approximately six months. ChemGenex submitted the NDA on 8 September 2009.
"We are pleased that the FDA has accepted our NDA for Omapro and granted the
filing Priority Review status which underscores the critical need for a
treatment option for the CML T315I+ patient population," said Greg Collier PhD,
ChemGenex`s Chief Executive Officer and Managing Director. "We look forward to
working closely with the agency over the next several months as they review our
filing. If approved, we plan to launch Omapro in the U.S. as the first therapy
specifically indicated for CML T315I patients."
Omapro has received Orphan Drug designation in the U.S. and in the European
Union, and has received Fast Track status from the FDA. Omapro demonstrated
clinical benefit in the pivotal Study 202 in CML patients who had failed
imatinib and have the T315I mutation.
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 submitted to the U.S. Food and Drug Administration 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, please visit the company`s website at
http://www.chemgenex.com.
Details on the clinical trials can be accessed from the following websites:
http://www.clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9
and http://www.tkiresistantcmltrials.com
Omapro is a trademark of ChemGenex Pharmaceuticals Limited
Safe Harbor Statement
Certain statements made herein (including for this purpose sites to which a
hyperlink has been provided) that use the words "estimate", "project", "intend",
"expect", "believe" and similar expressions are intended to identify
forward-looking statements within the meaning of the US Private Securities
Litigation Reform 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.
ChemGenex Information
Dr. Greg Collier
CEO and Managing Director
Cell (Australia): +61 419 897501
Cell (USA): +1-650-200-8145
gcollier@chemgenex.com
or
Buchan Consulting
Investor Relations - Australia
Rebecca Wilson, +61 (0)3 9866 4722
Cell: + 61 (0)417 382 391
rwilson@bcg.com.au
or
Blueprint Life Science Group
Investor Relations - USA
Remy Bernarda, +1-415-375-3340 ext. 2022
Cell: +1-415-203-6386
rbernarda@bplifescience.com
Copyright Business Wire 2009
