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Products & Pipeline


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Onrigin™ (laromustine) Injection
has been evaluated in trials for hematologic malignancies and solid tumors. In February 2009, we filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for our potential product, Onrigin™ (laromustine) Injection, formerly Cloretazine® (VNP40101M), for remission induction treatment of acute myeloid leukemia (AML) in elderly de novo poor-risk patients.
The Company has announced that the NDA has been accepted for a standard review by the FDA and that the user fee goal date for an FDA decision is December 12, 2009. There can be no assurance that the NDA will be approved by the FDA in 2009, or at all.

In addition, 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.

Triapine® is designed to prevent the replication of tumor cells by blocking ribonucleotide reductase, an enzyme critical to DNA synthesis and repair. Triapine® is in clinical trials sponsored by the National Cancer Institute.



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