Vion falls on Onrigin briefing documents

Vion Pharmaceuticals Inc. (OTCBB:VION) was off $2.75 (43%) to $3.60 on Friday after FDA said the company had not provided evidence for the efficacy and safety of Onrigin laromustine as a single agent for remission induction in patients ages 60 and up with de novo, poor-risk acute myelogenous leukemia (AML). The comments came in the agency's briefing documents for Tuesday's Oncologic Drugs Advisory Committee (ODAC) meeting to discuss an NDA for the sulfonyl hydrazine DNA alkylating agent, for which Vion is seeking accelerated approval. FDA also cited concerns with pulmonary toxicities that do not occur with standard AML treatments. Additionally, the agency noted that the Phase III CLI-037 trial -- which was placed on a clinical hold that was subsequently lifted -- showed a threefold increase in deaths in the Onrigin plus cytarabine arm vs. cytarabine alone in patients who would not be considered poor risk. The NDA has a PDUFA date of Dec. 12.

On the same day, ODAC also will discuss an sNDA from Genzyme Corp. (NASDAQ:GENZ) for Clolar clofarabine to treat AML in untreated patients ages 60 and up with at least one unfavorable baseline prognostic factor. In its briefing document, FDA raised two issues about the main Phase II CLO24300606 trial: a "substantial" number of patients (25-41%) in the trial may have been suitable candidates for standard induction chemotherapy or other intensive chemotherapy; and the trial was not randomized and had a heterogeneous patient population regarding AML prognostic factors, making interpretation of the results difficult. ...