ChemGenex’s Omacetaxine Shows Activity in Refractory CML
June 08 2009 - 8:00AM
Business Wire
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced that
positive, updated data from its phase 2/3 clinical trial study of
omacetaxine in chronic myeloid leukemia (CML) patients with
resistance to multiple tyrosine kinase inhibitors (TKIs) was
presented at the 14th Congress of the European Hematology
Association (EHA) in Berlin, Germany on Saturday.
Dr. Meir Wetzler MD, Chief of the Division of the Leukemia,
School of Medicine and Biomedical Sciences, University at Buffalo,
Roswell Park Cancer Institute, a lead investigator in the study,
presented the data. Dr. Wetzler said, �TKIs are our front line of
attack in CML, but significant numbers of patients have developed
cross resistance to drugs in this chemical class. As a physician I
need alternatives, so it is important to continue the search for
new drug entities to treat refractory CML. The data emerging from
this study provide encouraging signs that omacetaxine could offer a
viable therapeutic option for this patient group.�
Data were presented from 65 patients: 30 in chronic phase, 20 in
accelerated phase and 15 in blast phase. Highlights of the data
were:
Chronic phase patients
- Complete hematologic response
(CHR) rate of 80% with a median response duration 7.5 months
- Major cytogenetic response
(MCyR) rate of 20% with a median response duration 2.7 months
Accelerated phase patients
- CHR rate of 60% with a median
duration 8.9 months
Blast phase patients
- CHR rate of 40% with a median
duration 5.7 months
Tolerability
Investigators reported that omacetaxine is generally well
tolerated, and that the most common side effect is reversible and
transient myelosuppression.
Commenting on the presentation, Greg Collier, Chief Executive
Officer and Managing Director of ChemGenex said, �Omacetaxine has a
very different mechanism of action compared to the TKIs, and we
have always believed that it may offer the potential to overcome
TKI-resistance. The latest results of this study are very
encouraging, but this clinical trial is still at an early stage. In
the meantime, ChemGenex remains focused on our primary objective of
developing omacetaxine as a therapeutic option for CML patients who
have developed the T315I mutation. This is one of the most pressing
unmet medical needs in the field of CML management.�
Dr. Collier and ChemGenex�s Chief Medical Officer Dr. Adam Craig
will host an investor conference call and webcast to discuss the
clinical results from both ASCO and the EHA Congress on Thursday
11th of June at 10 am Australian Eastern Standard Time.
Webcast Details
Telephone access (toll free)
details are below:
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Online:
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About the trial
CGX-635-CML-203 is a phase 2/3 open-label study using
omacetaxine as a subcutaneous injection for the treatment of
patients with chronic myeloid leukemia (CML) who are intolerant to
or have failed multiple TKIs.
Omacetaxine Overview
Omacetaxine mepesuccinate 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). As omacetaxine acts independently of tyrosine kinase
inhibitors, it may have a therapeutic advantage for patients who
have developed resistance to TKIs. Omacetaxine is administered
subcutaneously.
About ChemGenex Pharmaceuticals Limited
(http://www.chemgenex.com)
ChemGenex Pharmaceuticals is a pharmaceutical development
company dedicated to improving the lives of patients by developing
personalized oncology medicines. ChemGenex harnesses the power of
genomics both to discover novel targets and drug compounds, and in
clinical trials to develop more individualized treatment outcomes.
ChemGenex�s lead compound, omacetaxine mepesuccinate, is currently
in phase 2/3 clinical trials for chronic myeloid leukemia (CML).
ChemGenex has a second anticancer compound, amonafide
dihydrochloride (Quinamed�), which is in phase 2 clinical
development for various solid cancers, and a portfolio of assets in
pre-clinical development. ChemGenex currently trades on the
Australian Stock Exchange under the symbol "CXS" and on NASDAQ
under the symbol "CXSP". For additional information on ChemGenex
Pharmaceuticals, please visit our web site at
http://www.chemgenex.com.
Details on the clinical trials can be accessed from the
following websites;
http://clinicaltrials.gov/ct2/show/NCT00375219?term=homoharringtonine&rank=9
and http://www.tkiresistantcmltrials.com
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