ChemGenex Pharmaceuticals Limited (ASX: CXS) announced that positive safety findings from a combined analysis of two clinical trials for its lead product candidate, OMAPRO™ (omacetaxine mepesuccinate), were presented today during a poster discussion session at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.
“We are in ongoing discussions with the FDA as we respond to the Complete Response letter to our New Drug Application for OMAPRO, and in Europe review of the Marketing Authorization Application by the EMA is proceeding according to schedule.”
Clinical investigators from cancer centres in the USA, Canada, France and Italy, reported on combined data from ChemGenex's two phase 2/3 clinical trials in chronic myeloid leukemia (CML) patients who either (a) had failed imatinib and had the T315I mutation, or (b) had failed imatinib and at least one other tyrosine kinase inhibitor (TKI). Data were presented from 170 patients: 93 in chronic phase, 42 in accelerated phase and 35 in blast phase. Conclusions from the analysis were:
- The primary toxicity of omacetaxine is hematologic, with infrequent grade 3/4 non-hematologic events experienced;
- Grade 3/4 hematologic adverse events were manageable and decreased in frequency and severity with dose adjustments; and,
- Injection site reactions were primarily grade 1/2 events, demonstrating that at-home subcutaneous administration of omacetaxine has an acceptable safety profile for CML patients who have failed prior therapies.
"Additional data continue to support that OMAPRO is safe and reinforces our belief that it is a promising candidate for CML patients who fail to respond adequately to tyrosine kinase inhibitors," said Greg Collier, Ph.D., Managing Director and Chief Executive Officer of ChemGenex. "We are in ongoing discussions with the FDA as we respond to the Complete Response letter to our New Drug Application for OMAPRO, and in Europe review of the Marketing Authorization Application by the EMA is proceeding according to schedule."
SOURCE ChemGenex Pharmaceuticals Limited