Vion Pharmaceuticals is a young company that has been breaking new ground with their lead oncology therapeutic Onrigin Injection. Today, results were announced of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which data for the Onrigin Injection was presented for the indication of remission induction treatment for patients 60 years of age or older with de novo poor-risk myeloid leukemia (AML).
The question the U.S. Food and Drug Administration asked ODAC was 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.
When asked what affect this will have on Vion, Alan Kessman who serves as the companyâ€™s CEO stated, “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.”
While this is a setback for Vion, the stock, which has been hovering in the $2-3 range, was trading at $1 this morning. If capital can be raised, Vion has the type of technology in place which can change the face of medicine and provide relief to cancer patients. While some may consider an investment in Vion a gamble, they need to realize that this stock has major upside potential and may be a steal at $1 a share.