The most common severe adverse events (Grade 3 through 5) in both arms were hematologic, infectious, and respiratory disorders. The duration of myelosuppression, as well as the incidence of infectious and respiratory adverse events, was higher in the treatment arm as compared to the control arm.
Alan Kessman, Chief Executive Officer, said, "Although this trial was discontinued for safety reasons due to a disparity in on-study mortality between the two arms, in light of the objective response rate of the cytarabine and Cloretazine(R) (VNP40101M) arm, we believe that this combination merits further evaluation in first relapse of AML with modifications to address the observed toxicity and mortality at the studied dose and schedule."
At ASCO(R), data were presented on the first 206 patients treated on the trial. The median age was 59 years and the median duration of patients' first remission was 9.7 months. 139 patients and 67 patients were treated on the treatment arm and the control arm respectively. The demographics of the patients in the treatment arm were essentially similar to patients in the control arm across age, sex, and ECOG performance status.
Mr. Kessman added, "Now that the clinical hold has been lifted by the FDA, we have the opportunity to move forward in first relapse of AML with a revised protocol of this combination. However, our main focus at the present time continues to be on achieving registration for Cloretazine(R) (VNP40101M) in the United States in previously untreated elderly patients with de novo poor-risk AML."
The Phase III trial was a double-blind placebo-controlled randomized
evaluation of a treatment arm consisting of cytarabine plus Cloretazine(R)
(VNP40101M) versus a control arm regimen of cytarabine and placebo. The
trial was designed to accrue patients i
|SOURCE Vion Pharmaceuticals, Inc.|
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