New Data Suggesting that ChemGenex’s Omacetaxine Can Eradicate Leukemic Stem Cells May Offer a Breakthrough in Treating CML
26 März 2009 - 11:40AM
Business Wire
Data showing the ability of omacetaxine to kill leukemic stem
cells in mouse models with drug-resistant chronic myelogenous
leukemia (CML) are the subject of an advance online publication in
the journal Leukemia, ChemGenex Pharmaceuticals Limited (ASX:CXS)
(NASDAQ:CXSP) announced today. The findings of this study provide
new insights into the problem of minimal residual disease and may
open the door to the development of a curative treatment strategy
for some patients with CML.
Commenting on the publication, Dr. Shaoguang Li, the study
leader at the University of Massachusetts Medical School, said,
�Omacetaxine killed 90% of the leukemic stem cells in vitro. In
contrast, imatinib and dasatinib, the two leading CML drugs, only
controlled 9% and 25% of these cancer stem cells, respectively. We
further demonstrated that omacetaxine prolonged survival in test
animals carrying the T315I mutation, which would normally render
them resistant to all currently available drugs.�
ChemGenex is currently developing omacetaxine as a potential
treatment for a range of blood malignancies, including CML, and is
completing a pivotal study in CML patients who harbor the T315I
mutation. The company expects to complete its filing of a New Drug
Application for use of omacetaxine in that patient population to
the U.S. Food and Drug Administration by mid-year.
In the USA, almost 5,000 new cases of CML are diagnosed each
year and recent estimates suggest that by 2025, prevalence will be
300,000. While there are a number of licensed drugs, collectively
known as tyrosine kinase inhibitors (TKIs), which are very
effective in treating CML, they must be administered daily for the
rest of the patient�s life; very few patients remain disease free
when these drugs are discontinued.
Hagop M. Kantarjian, M.D., Chairman and Professor, Department of
Leukemia, at the University of Texas M. D. Anderson Cancer Center,
described the study results as �very promising�. He added, �While
the currently licensed drugs target and disable the diseased cells
in the blood stream and bone marrow, they have little, if any,
affect on the primitive leukemic stem cells that are at the �root�
of this blood cancer. I look forward to working with ChemGenex in
future trials to evaluate the clinical application of these recent
findings.�
Greg Collier, Ph.D., Managing Director and Chief Executive
Officer of ChemGenex added, �The results of Dr. Li�s animal study
are very encouraging and we are currently collaborating with
Professor Tessa Holyoake from the United Kingdom, to carry out
similar investigations in primary human stem and progenitor cells.
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 and who are resistant to all
first and second line TKIs. This is the most pressing unmet medical
need in the field of CML management.�
About CML
CML is a form of leukemia characterized by the increased and
unregulated growth of undifferentiated myeloid cells in the bone
marrow and the accumulation of these non-functional cells in the
blood. Healthy myeloid cells should give rise to some of the most
important components of blood:
- red cells (to carry oxygen
around the body), platelets (to help with blood clotting) and
certain white cells (to help defend against infection).
CML patients therefore show symptoms of anemia and are prone to
bleeding and are susceptible to illnesses caused by bacterial and
fungal infections.
Minimal residual disease (MRD) is the name given, to
small numbers of leukemic cells that remain in the patient during
treatment, or after treatment when the patient is in remission (no
symptoms or signs of disease). It is the major cause of relapse in
cancer and leukemia.
About Omacetaxine
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, and induces apoptosis by inhibition of protein synthesis,
particularly Mcl-1. 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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