Exhibit 99.1
CHEMGENEX INITIATES NEW [GRAPHIC OMITTED] PHASE 2 TRIAL OF
CEFLATONIN(R) IN GLEEVEC(R) RESISTANT CML
INDICATION GRANTED ORPHAN DRUG STATUS IN EUROPE
MELBOURNE, AUSTRALIA, AND MENLO PARK, CALIFORNIA
U.S.A (OCTOBER 5, 2005): ChemGenex Pharmaceuticals Limited (ASX: CXS; NASDAQ:
CXSP) announced today that it has launched a new Phase 2 study evaluating the
use of Ceflatonin (sHHT) in patients with accelerated-phase chronic myeloid
leukemia (CML) who are resistant to the first line therapy Gleevec.
"The new trial builds on very positive results from our recent phase 1/2
clinical studies with sHHT in CML patients who are resistant to Gleevec" said
Greg Collier Ph.D, Chief Executive Officer of ChemGenex. "In one trial 78% of
patients treated with sHHT had their disease status down-graded from accelerated
phase to chronic phase. Chronic phase is a much more manageable stage of CML
disease progression and this is certainly a very favorable patient outcome. In
addition 67% of patients showed a complete hematologic response, which means a
disappearance of all findings consistent with accelerated stage CML, and a
return of white blood cell counts to normal."
The new study has been designed such that if promising results are confirmed
early in accelerated phase patients, it can be expanded into a Phase 2/3 study
by increasing the number of patients enrolled and adding chronic phase and blast
phase patient cohorts.
"It should also be noted that the recent studies utilized subcutaneous rather
than intravenous delivery of sHHT, and this will be our preferred treatment
route in future trials," Collier said.
The new study is a critical step in the commercialization of Ceflatonin.
"Positive results from the expanded phase 2/3 study will enable us to request
product registration from the FDA. We have recently been granted an Orphan Drug
Designation for sHHT in Europe for CML, and believe that with the increasing
number of patients who are becoming resistant to Gleevec, Ceflatonin will serve
a significant market if successfully developed."
The new Phase 2 trial will be an open-label, six (6) center study in France and
the United Kingdom for patients with accelerated-phase CML resistant to Gleevec.
In the remission induction phase, patients will receive 1.25 mg/m(2) sHHT by
subcutaneous injection two times a day for 14 days, every 4 weeks. In the
remission maintenance phase, patients will receive 1.25 mg/m(2) sHHT by
subcutaneous injection two times a day for 7 days, every 4 weeks. The Simon
Two-Stage study design will enroll 13 patients in stage 1 and then if sufficient
efficacy is observed enroll another 14-50 patients in stage 2 for a total of up
to 63 patients. The primary and secondary endpoints are hematologic and
cytogenetic response rates, respectively.
ChemGenex Initiates New Phase 2 Trial of Ceflatonin(R) in Gleevec(R)
Resistant CML Indication Granted Orphan Drug Status in Europe
PAGE 2 OF 3
ABOUT CHRONIC MYELOID LEUKEMIA
Chronic Myeloid Leukemia (CML) is a cancer of the blood cells caused by an
acquired genetic defect called the bcr-abl mutation. This defect occurs when
genetic material from two chromosomes (9 and 22) swaps places, creating the
so-called Philadelphia chromosome. The bcr-abl mutation interferes with normal
cell replication processes, leading to an abnormal proliferation of white blood
cells.
CML usually occurs in adults and typically progresses through three phases.
Patients generally are diagnosed in `chronic phase', progress through an
`accelerated phase' and then may die if the disease progresses to `blast phase'.
CML incidence is relatively consistent occurring at about 1 to 2 per 100,000
people and the global CML market for therapeutics is estimated at in excess of
US$2 billion.
Patients with chronic phase CML have been effectively treated in recent years by
the drug imatinib mesylate (Gleevec(R)). However, over time many patients become
resistant to the therapeutic effects of the drug and the disease progresses.
ABOUT CHEMGENEX PHARMACEUTICALS LIMITED (WWW.CHEMGENEX.COM)
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".
Gleevec(R) is a registered trade-mark of Novartis AG.
Contacts
Dr. Greg Collier (CEO and Managing Director) Australia +61 3 5227 2752
USA +1 650 474 9800 ext 103
Dr. Dennis Brown (President and Director) USA +1 650 474 9800 ext 108
Australia +61 3 5227 2703
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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
ChemGenex Initiates New Phase 2 Trial of Ceflatonin(R) in Gleevec(R)
Resistant CML Indication Granted Orphan Drug Status in Europe
PAGE 3 OF 3
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