Exhibit 99.1
[GRAPHIC OMITTED)
ChemGenex
FOR IMMEDIATE RELEASE
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ChemGenex Announces Strategy for Registration-Directed Clinical Trials for
Ceflatonin(R)
MELBOURNE, Australia, and MENLO PARK, California U.S.A. (July 18, 2005):
ChemGenex Pharmaceuticals Limited (ASX: CXS; NASDAQ: CXSP), based in Melbourne,
Australia and Menlo Park, Ca, USA, today announced its accelerated clinical
development plan for its lead anti-cancer therapeutic, Ceflatonin(R)
(homoharringtonine, HHT).
The initiation of the first of two registration-directed Phase 2/3 trials is
scheduled for the third quarter of 2005. The first trial will target chronic
myeloid leukemia (CML) accelerated phase patients who are resistant to high-dose
Gleevec(R). The single agent Phase 2/3 trial will initially be conducted in six
leading European cancer centres, and is expected to expand to incorporate cancer
centres in the U.S. in Q1, 2006. The trial incorporates the benefits of the
company's recent in-licensing agreement with Stragen Pharma and builds on
growing clinical evidence that Ceflatonin(R) has significant potential as a
treatment for CML patients who are resistant to Gleevec(R) and other
experimental bcr-abl kinase inhibitors. It is anticipated that the enrolment in
this trial of up to 85 patients will be completed in Q4, 2006.
A second single agent Phase 2/3 clinical trial with Ceflatonin(R) to treat CML
patients with a specific gene mutation that makes them resistant to tyrosine
kinase inhibitors such as Gleevec(R) (the T315I bcr-abl mutation) is planned to
commence in the U.S. and Europe in Q1, 2006, and will recruit up to 85 patients.
This study will be initiated based on evidence from recent Phase 1/2 studies
that HHT has activity in CML patients who have developed bcr-abl point mutations
associated with tyrosine kinase inhibitor resistance.
ChemGenex has ongoing Phase 2 clinical trials under its U.S. IND at the M.D.
Anderson Cancer Center in Houston, Texas (Ceflatonin(R) in combination with
Gleevec(R) in CML and Ceflatonin(R) as a single agent in myelodysplastic
syndrome (MDS)).
"This is a major advance in our clinical development of Ceflatonin(R)" said Dr
Greg Collier, Chief Executive Officer and Managing Director of ChemGenex
Pharmaceuticals. "The new trial designs offer considerable advantages; we have
developed protocols for the sub-cutaneous, rather than intravenous dosing of
patients and we have new data demonstrating synergy when used in-combination
with Gleevec(R). As the number of CML patients developing bcr-abl point
mutations associated with resistance to tyrosine kinase inhibitors such as
Gleevec(R) increases, there will be considerable need for treatments such as
Ceflatonin(R) that combat the disease via a different mechanism."
ChemGenex Announces Strategy for Registration-Directed Clinical Trials for
Ceflatonin(R)
ChemGenex has updated its company overview presentation to include the new
clinical strategy for Ceflatonin(R). The presentation can be accessed from the
company's home page (www.chemgenex.com).
About ChemGenex Pharmaceuticals Limited (www.chemgenex.com)
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ChemGenex Pharmaceuticals is a gene-based pharmaceutical company dedicated to
improving the lives of patients by developing therapeutics in the areas of
oncology, diabetes, obesity, and depression. ChemGenex currently has two
compounds in Phase 2 clinical trials, Ceflatonin(R) for leukemia and Quinamed(R)
for solid tumors, and has a significant portfolio of anti-cancer, diabetes,
obesity and depression programs. The company's diabetes and obesity program is
partnered with Merck KGaA and the depression program is partnered with Vernalis
plc. ChemGenex currently trades on the Australian Stock Exchange under the
symbol "CXS" and the NASDAQ exchange under the symbol "CXSP".
Contacts
Dr. Greg Collier (CEO and Managing Director) Australia +61 3 5227 2752
USA (650) 474-9800 ext 103
Dr. Dennis Brown (President and Director) USA (650) 474-9800 ext 108
Australia +61 3 5227 2703
Mr Hershel Berry (Investor Relations) USA (415) 392-3310
Safe Harbor Statement
Certain statements made herein 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.
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PO Box 1069, Grovedale Victoria 3216, Australia +61 3 5227 2752 +61 3 5227 1322
chemgenex@chemgenex.com 79 000 248 304
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