Published on September 3, 2009 at 5:21 AM
VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced the results of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which data for its lead oncology therapeutic Onrigin(TM)(laromustine) Injection were presented for the indication of remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML).
The ODAC was asked by the U.S. Food and Drug Administration (FDA) to vote on the question of whether a randomized study defining the efficacy and safety of Onrigin in the population proposed for the indication be completed prior to regulatory approval of Onrigin. The ODAC voted 13-0 in favor of completion of a randomized study prior to approval. 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 FDA.
Alan Kessman, Chief Executive Officer, commented, "We are disappointed that the Oncologic Drugs Advisory Committee voted for completion of a randomized trial for Onrigin in the elderly poor-risk AML population prior to approval. We plan to enter into discussions with the FDA about their requirements for a randomized trial and evaluate our options as soon as possible. We would need to raise additional capital to finance a new randomized trial."
The Company reported $26.1 million in cash and cash equivalents at the end of the second quarter of 2009. The Company's current operating plan does not include funding for an additional randomized trial and there can be no assurance that additional capital can be raised.
Source: http://www.vionpharm.com