If CXS trial results continue to come in like this, where people...

If CXS trial results continue to come in like this, where people with such advanced states of Leukemia achieve "complete haematological responses", then where to for share price ?



MELBOURNE, Australia, and MENLO PARK, California U.S.A. (September 24, 2007).
ChemGenex Pharmaceuticals Limited (ASX:CXS and NASDAQ:CXSP) announced today the
publication of a clinical communication in Blood (the journal of the American Society of Hematology)
demonstrating clinical activity of the company’s lead compound, Ceflatonin® (Homoharringtonine,
HHT1) against Gleevec® (imatinib mesylate)-resistant, accelerated phase chronic myeloid leukemia
(CML) associated with the T315I BCR-ABL kinase domain mutation.
The publication describes positive clinical outcomes for two CML patients with the T315I BCR-ABL
kinase domain mutation, one of whom was treated with Ceflatonin, the other was treated with
interferon-alpha. The T315I BCR-ABL mutation results in resistance to tyrosine kinase inhibitor (TKI)
drugs, including Gleevec, Sprycel® (dasatinib), and Tasigna® (nilotinib) that are currently used to treat
CML patients. As a result, therapeutic options for CML patients with this mutation are very limited, and
there is a significant unmet medical need for novel therapies to treat these patients.
The patient treated with Ceflatonin was resistant to Gleevec and Sprycel and had progressed to
accelerated-phase CML with 100% of BCR-ABL positive cells showing the T315I mutation. The
authors, Dr. Hugues de Lavallade and his associates, including Professor John M. Goldman and Dr.
David Marin of the Hammersmith Hospital and Imperial College, London, UK, reported that the patient
experienced a 30% reduction of T315I BCR-ABL levels within one month of the initiation of Ceflatonin
treatment and a complete hematological response after five months.
The Blood publication follows a clinical report in Leukemia in May, 2007, describing clinical activity for
Ceflatonin in another CML patient harboring the T315I BCR-ABL kinase domain mutation. Together,
these two reports strongly support ChemGenex’s clinical and regulatory approval program.
ChemGenex is currently undertaking two phase 2/3 clinical trials in CML – the first trial includes
Gleevec-resistant patients with the T315I BCR-ABL kinase domain mutation, and the second trial is for
1 ChemGenex recently received United States Adopted Names (USAN) Council approval for its proposed
International Non-Proprietary Name (INN) for Ceflatonin. The new non-proprietary name is omacetaxine
mepesuccinate, representing the first in the new family of ‘cetaxine’ drugs. The Company will phase in the use of
omacetaxine mepesuccinate in place of the previous non-proprietary name (homoharringtonine, HHT) in its
written materials. The Company has also initiated a project for the development of a new trade name for the drug
as part of a pre-commercialization strategy.
ChemGenex Announces Second Publication Demonstrating Activity of Ceflatonin® in T315I-Positive
CML
Page 2 of 3
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CML patients who are resistant to treatment with two or more of the current TKI drugs available.
Positive results from the two trials may support the filing of a New Drug Application (NDA) with the US
Food and Drug Administration and other regulatory authorities.
“The Blood and Leukemia publications are consistent with the understanding that Ceflatonin works via
a different mechanism than the current TKI therapies,” said Greg Collier, Chief Executive Officer and
Managing Director of ChemGenex.
“Documented activity in both a chronic phase and an accelerated phase CML patient with the T315I
BCR-ABL kinase domain mutation strongly supports Ceflatonin as a potential new therapeutic option
for the growing number of patients identified with this mutation,” Dr Collier added. “Estimates indicate
that the global CML market will approach US$4 billion in 2008, and it is clear that therapeutics that
overcome limitations with existing TKIs will play an important part in the treatment of CML patients.”
For current clinical trial information search “Ceflatonin” at www.clinicaltrials.gov.