ChemGenex Announces Publication Confirming Activity of Ceflatonin(R) in T315I-Positive CML
12 June 2007 - 6:30AM
Business Wire
ChemGenex Pharmaceuticals Limited (ASX:CXS and NASDAQ:CXSP)
announced today the publication of a report in the prestigious
Nature publication Leukemia confirming the positive clinical
activity of the company�s lead compound, Ceflatonin� against
Gleevec�-resistant, chronic myeloid leukemia (CML) associated with
the T315I Bcr-Abl mutation. The T315I mutation is known to confer
resistance to both Gleevec (imatinib mesylate) and
second-generation tyrosine kinase inhibitors (dasatinib and
nilotinib). Recent publications indicate that the incidence of
T315I-associated resistance is increasing and confirm that this
mutation is likely to become the prevalent mutation in those who
fail tyrosine kinase inhibitor therapy. The publication by Dr.
Laurence Legros of the H�pital Archet, Nice, France and colleagues
describes the treatment with Ceflatonin (homoharringtonine, HHT) of
a Gleevec-resistant, chronic-phase CML patient with the T315I
Bcr-Abl mutation. The authors report that the patient experienced a
50 percent reduction of T315I Bcr-Abl levels within 2.5 months of
treatment initiation, and the complete disappearance of the
mutation within 5.5 months of treatment. Complete hematological
response (CHR) was achieved after three cycles of therapy. Based on
the clinical results, the authors believe that the rapid and
complete disappearance of the T315I mutation might suggest a
particular sensitivity of this mutation to HHT. The authors
conclude that HHT �may provide an alternative therapeutic treatment
option for CML patients with the T315I mutation, for whom therapies
have been previously lacking.� The authors also noted some
hematologic toxicities (neutropenia, thrombocytopenia and anemia),
but confirmed that the toxicity of HHT was �easy to manage�. �We
are delighted with this publication that reinforces our belief in
the potential of Ceflatonin to treat patients with the T315I
Bcr-Abl mutation,� said Greg Collier, Ph.D., Chief Executive
Officer and Managing Director of ChemGenex. ChemGenex is currently
treating patients in two clinical studies that are designed to
support the filing of New Drug Applications (NDAs) for the
treatment with Ceflatonin of sub-sets of CML patients. The first
study, is for Gleevec-resistant patients with the T315I point
mutation and the complementary second study is for CML patients who
are resistant to, or intolerant to treatment with two or more
tyrosine kinase inhibitors. �We believe that Ceflatonin offers
significant potential as a therapeutic alternative for these
unserved and growing CML patient populations,� Dr Collier added.
Publication details BCR-ABLT315I transcript disappearance in an
Imatinib-resistant CML patient treated with Homoharringtonine: A
new therapeutic challenge? Leukemia advanced online publication May
31, 2007. Laurence Legros1, Sandrine Hayette2, Franck E. Nicolini3,
Sophie Raynaud4, Kaddour Chabane2, Jean-Pierre Magaud2,
Jill-Patrice Cassuto1, Mauricette Michallet3 1 Hematology
Department, H�pital Archet 1, 06202 Nice, France; 2 Laboratory for
cytogenetics and molecular biology and EA3737, Centre Hospitalier
Lyon Sud, 69495 Pierre-B�nite, France; 3 Hematology Department,
H�pital Edouard Herriot, 5 place d�Arsonval 69437 Lyon, France; 4
Hematology Laboratory, H�pital Archet 2, 06202 Nice, France.
Ceflatonin� is a registered trademark of ChemGenex Pharmaceuticals
Limited. Gleevec�/Glivec� is a registered trademark of Novartis AG.
About ChemGenex Pharmaceuticals Limited (www.chemgenex.com)
ChemGenex Pharmaceuticals is a pharmaceutical development company
dedicated to improving the lives of patients by developing
therapeutics in the areas of oncology, diabetes and obesity.
ChemGenex harnesses the power of genomics for target discovery and
validation, and in clinical trials to develop more individualized
therapeutic outcomes. ChemGenex�s lead compound, Ceflatonin�, is
currently in phase 2/3 clinical trials for chronic myeloid leukemia
(CML) and Quinamed� is in phase 2 clinical development for
prostate, breast and ovarian cancers. The company has a significant
portfolio of anti-cancer, diabetes and obesity programs, several of
which have been partnered with international pharmaceutical
companies. ChemGenex currently trades on the Australian Stock
Exchange under the symbol "CXS" and on NASDAQ under the symbol
"CXSP". 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
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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
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number of uncertainties that could change the results described in
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there are no assurances that results will not differ from those
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