NEW HAVEN, Conn., June 1 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC BULLETIN BOARD: VION) today announced that an analysis of clinical data of its lead anticancer agent Onrigin (laromustine) Injection in patients over the age of sixty with acute myeloid leukemia (AML) was presented in a poster at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting in Orlando, Florida.
Ann Cahill, Vice President, Clinical Development, commented, 'This poster presents an objective analysis of the co-morbid conditions with which so many elderly AML patients present. It demonstrates that the patient population forming the basis of the efficacy claims in Vion's New Drug Application was indeed a poor-risk population, with multiple risk factors predicting for a poor prognosis.'
In the analysis, 140 AML patients over the age of sixty treated with Onrigin in two Phase II clinical trials were analyzed for co-morbidity according to the hematopoetic cell transplantation-specific co-morbidity index (HCT-CI). The HCT-CI is an adapted version of the Charlson Comorbidity Index (CCI), and was originally developed to predict outcomes in patients undergoing allogeneic stem cell transplant. It has since been used to describe outcome for AML patients receiving induction chemotherapy. HCT-CI scores have been shown to be predictive of early death and survival in patients over the age of 60 receiving induction therapy for AML.
The 140 patients included all 85 patients from the Company's pivotal trial in elderly poor-risk AML, and 55 patients in a retrospectively determined subset from a previous trial in elderly AML. The median age of this population was 74 years. HCT-CI scores were separated into three risk groups for non-relapse mortality and survival: low (0), intermediate (1-2), and high (3 or greater). The analysis established that 81% of the patients in the combined population had an HCT-CI score of 3 or greater and that the median score was 5 (range 0-12), confirming the poor-risk nature of this patient group. Patients with an HCT-CI score of 3 or greater had an overall response rate of 34%, an induction death rate (death within 30 days of first induction) of 14%, and a Kaplan-Meier estimate of survival at twelve months of 21%.
About Vion
Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative oncology therapeutics. Vion has two agents in clinical trials, Onrigin (laromustine) Injection and Triapine(R).
