Aug 10 2009
Vion Pharmaceuticals (OTC Bulletin Board: VION) today announced the date and location of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which its lead oncology therapeutic Onrigin(TM) (laromustine) Injection will be presented.
The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the U.S. Food and Drug Administration (FDA).
The meeting will be held on September 1, 2009 at the Hilton Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, MD. Background materials for the meeting are expected to be made available by the FDA on its website no later than two business days before the meeting.
Alan Kessman, Chief Executive Officer, commented, "We look forward to our meeting with the Oncologic Drugs Advisory Committee in September. It is one more step towards achievement of our main objective which is approval for Onrigin(TM) in its first indication in the United States in 2009."
The Company announced previously that it had received a standard review classification from the FDA for its New Drug Application (NDA) for Onrigin(TM) and a user fee goal date of December 12, 2009 for a decision by the FDA with respect to approval.
The NDA presents data for Onrigin(TM) as a single agent for remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML). The NDA is based on the results of an international multi-center pivotal Phase II trial of 85 patients sixty years of age or older with de novo poor-risk AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML. Eighty-six percent of these 140 patients had two or more risk factors that predicted for a poor prognosis.