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ChemGenex Announces Positive Preliminary Data from Phase 2/3 Clinical Trial of Ceflatoninr at International Conference
10 / 10 / 2007
ChemGenex Pharmaceuticals (ASX: CXS, NASDAQ: CXSP) announced today the first presentation of early clinical data from its registration-directed phase 2/3 clinical study of Ceflatoninr (omacetaxine mepesuccinate) at the Fourth ESH International Conference on Chronic Myeloid Leukaemia in Mandelieu, France. The presentation by Dr Franck Nicolini of the Hpital Edouard Herriot in Lyon, France described the growing problem posed by the T315I point mutation in the treatment of chronic myeloid leukemia (CML) and presented data from four chronic phase T315I positive CML patients who have all benefited from treatment with Ceflatonin.
Highlights of the presentation entitled "Retrospective Analysis of T315I KD Mutations and Future Therapeutic Options in CML" include:
1. Clinical opinion that CML patients who are confirmed as being T315I positive should be withdrawn from tyrosine kinase inhibitor (TKI) therapy immediately as ongoing TKI therapy will increase the likelihood of disease progression.
2. Data on four Gleevecr (imatinib mesylate)-resistant chronic phase, T315I positive CML patients treated in Lyon by Dr Nicholini and Dr Michallet and in Nice by Dr Legros which showed hematologic response, disease stabilization and dramatic reductions in the levels of the T315I mutation in all patients treated. Ceflatonin was generally well tolerated, and no patients demonstrated unacceptable side-effects.
Dr Nicolini said "I believe that subcutaneous Ceflatonin is today one of the best options to consider for chronic phase CML patients harbouring a T315I BCR-ABL mutation and lacking a histocompatibility donor."
Greg Collier, Ph.D., Chief Executive Officer and Managing Director of ChemGenex said that the results presented were a strong endorsement of the potential for Ceflatonin to play a significant part in the therapeutic armoury against CML. "The data that Dr Nicolini presented today show very clearly that at this early stage we are seeing positive effects in CML patients who, because of the T315I mutation, are resistant to Gleevec These results support our belief that Ceflatonin has significant clinical potential for CML patients who become resistant to tyrosine kinase inhibitors and other therapies."
Highlights of the presentation entitled "Retrospective Analysis of T315I KD Mutations and Future Therapeutic Options in CML" include:
1. Clinical opinion that CML patients who are confirmed as being T315I positive should be withdrawn from tyrosine kinase inhibitor (TKI) therapy immediately as ongoing TKI therapy will increase the likelihood of disease progression.
2. Data on four Gleevecr (imatinib mesylate)-resistant chronic phase, T315I positive CML patients treated in Lyon by Dr Nicholini and Dr Michallet and in Nice by Dr Legros which showed hematologic response, disease stabilization and dramatic reductions in the levels of the T315I mutation in all patients treated. Ceflatonin was generally well tolerated, and no patients demonstrated unacceptable side-effects.
Dr Nicolini said "I believe that subcutaneous Ceflatonin is today one of the best options to consider for chronic phase CML patients harbouring a T315I BCR-ABL mutation and lacking a histocompatibility donor."
Greg Collier, Ph.D., Chief Executive Officer and Managing Director of ChemGenex said that the results presented were a strong endorsement of the potential for Ceflatonin to play a significant part in the therapeutic armoury against CML. "The data that Dr Nicolini presented today show very clearly that at this early stage we are seeing positive effects in CML patients who, because of the T315I mutation, are resistant to Gleevec These results support our belief that Ceflatonin has significant clinical potential for CML patients who become resistant to tyrosine kinase inhibitors and other therapies."