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Cloretazine Receives Fast Track Designation
The FDA's fast track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
An estimated 11,920 individuals will develop AML and an estimated 8,870 will die from the disease in the United States in 2004 (Source: CA: A Cancer Journal for Clinicians, January/February 2004). Many patients with AML respond favorably to initial chemotherapy, but in most the disease recurs and ultimately becomes resistant to additional treatment.
Alan Kessman, Chief Executive Officer, stated, "Our preclinical and initial clinical data indicate that CLORETAZINE(TM) (VNP40101M) has the potential to improve treatment for patients with relapsed or refractory AML, and therefore, we are very pleased that the FDA has given the agent fast track status. We look forward to working closely with the FDA as we continue to evaluate CLORETAZINE(TM) (VNP40101M) in current and future clinical trials."
Vion Pharmaceuticals, Inc. is developing novel agents for the treatment of cancer. Vion has two agents in clinical trials: Triapine®, a potent inhibitor of a key step in DNA synthesis and CLORETAZINE(TM) (VNP40101M), a unique sulfonyl hydrazine DNA alkylating agent. Agents in preclinical studies include: TAPET®, a modified Salmonella vector used to deliver anticancer agents directly to tumors and KS119, a hypoxia-selective compound from the sulfonyl hydrazine class. Vion is also developing and has an option to license several heterocyclic hydrazones which have demonstrated potent anti-tumor activity in preclinical studies. For additional information on Vion and its product development programs, visit the Company's Internet web site at www.vionpharm.com.
Source: Vion Pharmaceuticals, Inc.