NEW HAVEN, Conn., Dec. 8 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced that additional survival data on its anticancer agent Onrigin(TM) (laromustine) injection was presented by the Company in a poster at the 50th American Society of Hematology Annual Meeting.
The poster presented survival data for a combined group of 140 de novo poor-risk acute myelogenous leukemia (AML) patients age 60 or older who achieved either a complete response (CR) or a complete response with incomplete platelet recovery (CRp) to Onrigin(TM).
The Kaplan-Meier estimate of median overall survival for patients who responded to Onrigin(TM) was 8.4 months. Median overall survival for all patients was 3.3 months. Six, twelve and twenty-four month survival rate estimates were as follows:
Responders (N=52) All Patients (N=140)
6 months 57% 34%
12 months 39% 21%
24 months 20% 10%
Ann Cahill, Vice President, Clinical Development, commented, 'In the treatment of AML, achievement of a complete response is the critical first step in the continuum of care.' She added, 'We believe that Onrigin(TM), if approved, will represent an important new treatment option for these poor-risk AML patients.'
The overall response rate (CR plus CRp) in the combined group was 37%, with 40 patients (29%) achieving a CR and 12 patients (9%) achieving a CRp. The induction death rate (death within thirty days from all causes) was 14%. The most common Serious Adverse Events (SAEs) for the combined patient group were in the following system organ classes: infections and infestations (34%); blood and lymphatic disorders (24%) and respiratory, thoracic and mediastinal disorders (22%).
The analysis included patients from two clinical trials conducted by the Company in elderly AML patients in the past four years: (i) 85 de novo poor-risk patients were from a pivotal Phase II study, CLI-043, and (ii) a subset of 55 de novo poor-risk patients who reasonably met the eligibility criteria for CLI-043 were retrospectively identified from an additional Phase II study, CLI-033. In both studies, all patients received 600 mg/m2 of Onrigin(TM) in a single induction infusion of 30-60 minutes. Sixteen percent of the patients from both studies received a second induction dose of 600 mg/m2 of Onrigin(TM). Twenty-four percent of the combined patients received consolidation treatment upon achieving a response.