Published: June 06, 2010
ChemGenex Announces Positive Safety Data on OMAPRO Presented at ASCO
MELBOURNE, Australia & MENLO PARK, Calif. - (BUSINESS WIRE) - ChemGenex Pharmaceuticals Limited (ASX: CXS) announced that positive
safety findings from a combined analysis of two clinical trials for its
lead product candidate, OMAPRO (omacetaxine mepesuccinate), were
presented today during a poster discussion session at the 2010 American
Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
Clinical investigators from cancer centres in the USA, Canada, France
and Italy, reported on combined data from ChemGenex's two phase 2/3
clinical trials in chronic myeloid leukemia (CML) patients who either
(a) had failed imatinib and had the T315I mutation, or (b) had failed
imatinib and at least one other tyrosine kinase inhibitor (TKI). Data
were presented from 170 patients: 93 in chronic phase, 42 in accelerated
phase and 35 in blast phase. Conclusions from the analysis were:
-
The primary toxicity of omacetaxine is hematologic, with infrequent
grade 3/4 non-hematologic events experienced;
-
Grade 3/4 hematologic adverse events were manageable and decreased in
frequency and severity with dose adjustments; and,
-
Injection site reactions were primarily grade 1/2 events,
demonstrating that at-home subcutaneous administration of omacetaxine
has an acceptable safety profile for CML patients who have failed
prior therapies.
"Additional data continue to support that OMAPRO is safe and reinforces
our belief that it is a promising candidate for CML patients who fail to
respond adequately to tyrosine kinase inhibitors," said Greg Collier,
Ph.D., Managing Director and Chief Executive Officer of ChemGenex. "We
are in ongoing discussions with the FDA as we respond to the Complete
Response letter to our New Drug Application for OMAPRO, and in Europe
review of the Marketing Authorization Application by the EMA is
proceeding according to schedule."
About OMAPRO (omacetaxine mepesuccinate)
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 up-regulated in leukemic cells (particularly
Cyclin-D1, Mcl-1 and c-Myc).
Omacetaxine mepesuccinate is administered subcutaneously and acts
differently from TKIs. It may have a therapeutic advantage for patients
who have failed TKIs. Omacetaxine has completed two phase 2/3 clinical
trials for subsequent indications within 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.
About Chronic Myeloid Leukemia (CML)
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.
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 is under review
by the U.S. Food and Drug Administration and a Marketing Authorisation
Application is under review 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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ChemGenex Pharmaceuticals Limited
Dr. Greg Collier
Cell
(Australia): +61 419 897501
Cell (USA): +1-650-200-8145
CEO
and Managing Director
gcollier@chemgenex.com
or
Buchan
Consulting
Investor Relations - Australia:
Kyahn Williamson,
+61 (0)3 9866 4722
Cell: + 61 (0)401 018 828
kwilliamson@bcg.com.au
or
Blueprint
Life Science Group
Investor Relations - USA:
Remy Bernarda,
+1-415-375-3340 x 2022
Cell: +1-415-203-6386
rbernarda@bplifescience.com
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