Laromustine (Onrigin) needs more data to prove safety, says US FDA; Vion faces liquidation

Vion Pharmaceutical has met with a major roadblock in its future course of action as US FDA has rejected its experimental blood cancer drug laromustine (Onrigin) injection wanting more data to establish the safety of the drug.

Vion Pharmaceuticals submitted its New Drug Application (NDA) for Onrigin (laromustine) injection in February 2009 with the U.S. Food and Drug Administration.

In September, the Oncologic Drugs Advisory Committee (ODAC) voted 13-0 in favor of completion of a randomized study prior to approval for Onrigin (laromustine).

US FDA’s 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.

Onrigin (laromustine) Injection trial data 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).

Vion Pharmaceuticals 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.

Now US FDA, in the new complete response letter advised that Vion complete a randomized study or studies to define the efficacy and safety of Onrigin in the patient population proposed for the indication, and that the study or studies should be designed to demonstrate a survival benefit that is clearly attributable to Onrigin with an acceptable safety profile in a well-characterized patient population.

Vion Pharma was also requested to provide an update on Onrigin safety information when the
issues above had been addressed.

Vion has terminated its agreement with Merriman Curhan Ford & Co. and that it had retained Roth Capital Partners, LLP as its advisor to assist the company in its evaluation
of strategic alternatives.

Vion previously announced the the company does not have sufficient capital to fund a new randomized study of Onrigin. And Vion may have to curtail or cease operations, liquidate its assets or file for bankruptcy.

Vion Pharmaceuticals, Inc. is developing novel agents for the treatment of cancer. Vion has two small molecule anticancer compounds under evaluation in human clinical trials.

Four clinical trials of Onrigin are underway in: (i) AML and myelodysplastic syndrome (MDS) in combination with cytarabine; (ii) AML and MDS in combination with standard remission-induction therapy; (iii) AML with unfavorable cytogenetics in combination with standard remission-induction chemothrapy; and (iv) brain tumors in combination with temozolomide.

Vion’s second potential product, Triapine, is being evaluated in trials sponsored by the National Cancer Institute.

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative oncology therapeutics.

Triapine, a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute.