ChemGenex to Present Positive Data for Omapro™ From Multiple Clinical Trials at ASH
November 30 2009 - 5:30PM
Business Wire
ChemGenex Pharmaceuticals Limited (ASX:CXS) announced today that
updated clinical data from several of its clinical trials with
Omapro™ (omacetaxine mepesuccinate) will be presented at the
upcoming 51st American Society of Hematology Annual Meeting in New
Orleans, Louisiana.
Dr. Jorge Cortes, MD, Professor of Medicine and Deputy Chair in
the Department of Leukemia at The University of Texas, MD Anderson
Cancer Center will present data via oral presentations for both the
ChemGenex studies 202 and 203.
On Monday, 7th December at 4:45 p.m. Central Time, Dr. Cortes
will present data from “Imatinib-Resistant Chronic Myeloid Leukemia
(CML) Patients Who Harbor the Bcr-Abl T315I Mutation in an oral
session entitled: Chronic Myeloid Leukemia - Therapy: Managing
Resistance and Residual Disease.”
During the oral session entitled Chronic Myeloid Leukemia -
Therapy: New Trends in Management, Dr. Cortes will present data
from “CML Patients Who Are Resistant or Intolerant to Two or More
Tyrosine Kinase Inhibitors.” This session will take place on
Tuesday, 8th December at 8:00 a.m. Central Time.
ChemGenex will also present combination data for Omapro during
the poster session entitled: Chronic Myeloid Leukemia - Therapy on
Sunday, December 6th from 6:00 to 8:00 p.m. Central Time on Poster
Board II-170. This phase 2 trial was designed to study the
“Combination of Omacetaxine and Imatinib in the Treatment of
Patients with CML in Advanced Stages or After Failure to
Imatinib”.
About Omapro™ (omacetaxine mepesuccinate)
Omacetaxine mepesuccinate is administered subcutaneously and
acts differently from tyrosine kinase inhibitors (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)
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. 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 accepted by the U.S. Food and Drug
Administration and a Marketing Authorization Application has been
validated by the European Medicines Evaluation Agency 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
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to which a hyperlink has been provided) that use the words
“estimate”, “project”, “intend”, “expect”, “believe” and similar
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unknown risks and uncertainties which could cause the actual
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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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