Vion Pharmaceuticals Presents Additional Survival Data on Onrigin (Laromustine) Injection at ASH Annual Meeting
NEW HAVEN, Conn., December 08, 2008 /PRNewswire-FirstCall/ -- 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 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 poor-risk patients were from a pivotal Phase II study, CLI-043, and (ii) a subset of 55 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. Patients in CLI-043 received consolidation with 400 mg/m2 of cytarabine per day for five days and patients in CLI-033 received consolidation with 400 mg/m2 of Onrigin(TM).
Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative cancer therapeutics. Vion has two agents in clinical trials. Onrigin(TM) (laromustine) injection, formerly known as Cloretazine (VNP40101M), a unique alkylating agent, is being evaluated in a Phase II pivotal trial as a single agent in elderly patients with previously untreated poor-risk acute myelogenous leukemia. Clinical trials of Onrigin(TM) with cytarabine in elderly patients with acute myelogenous leukemia, with standard remission-induction therapy in patients with AML and myelodysplatic syndromes (MDS), with temozolomide in brain tumors, and with stem cell transplantation in advanced hematologic malignancies, are also being conducted. Triapine, a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.
COMPANY CONTACT: Vion Pharmaceuticals, Inc. Alan Kessman, Chief Executive Officer Howard B. Johnson, President & CFO (203) 498-4210 phone
CONTACT: Alan Kessman, Chief Executive Officer, or Howard B. Johnson,President & CFO, both +1-203-498-4210, both of Vion Pharmaceuticals, Inc.
Web site: http://www.vionpharm.com/
Ticker Symbol: (NASDAQ-OTCBB:VION),(NASDAQ-OTCBB:VION)
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Posted: December 2008