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Vion Pharmaceuticals Submits New Drug Application for Onrigin(TM)
Date:2/17/2009

s. Onrigin's ability to generate meaningful complete responses after a single sixty-minute infusion makes its utility in this patient population particularly attractive."

About Onrigin

Onrigin (laromustine) Injection, formerly known as Cloretazine(R) (VNP40101M), is a novel alkylating agent. Onrigin has been evaluated in over 800 patients in 16 clinical trials to date, including a pivotal Phase II trial in patients sixty years of age or older with de novo poor-risk AML. There are four clinical trials of Onrigin underway: (i) the continuation of the pivotal Phase II trial; (ii) a Phase III trial with standard remission-induction therapy in patients with AML and myelodysplastic syndromes (MDS); (iii) a Phase I/II trial in combination with cytarabine in elderly patients with AML; and (iv) a Phase I/II trial in combination with temozolomide in patients with brain tumors.

About Acute Myeloid Leukemia (AML)

The American Cancer Society estimates that 13,290 new cases of AML were diagnosed in the U.S. in 2008. AML is primarily a disease of the elderly, with a median age at onset of 67 years. Compared to younger patients, older AML patients have a lower rate of response to currently available induction chemotherapy and shorter overall survival due, in part, to unfavorable prognostic factors such as a higher incidence of adverse cytogenetics and frequent co-morbidities. In addition, patients with risk factors such as advanced age and poor performance status tolerate current induction treatments poorly. A 2005 study by Lang et al, based on data from the National Cancer Institute's Survey of Epidemiological and End Results (SEER) database, indicated that palliative care is given to the majority of elderly patients with AML in the U.S., providing additional evidence that new treatment options are needed for this population.

About Vion

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SOURCE Vion Pharmaceuticals, Inc.
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