Vion Pharmaceuticals, Inc. has accrued 210 patients to the phase III trial of its lead anticancer agent Cloretazine (VNP40101M). The trial is evaluating Cloretazine (VNP40101M) in combination with cytarabine for the treatment of relapsed acute myelogenous leukaemia (AML).
The protocol for this international phase III randomised study includes a planned interim analysis on the first 210 patients. With the time required for treating and following these patients for a response assessment, the company believes that these data should be available for review by the data safety monitoring board for the trial in March or April of 2007.
The trial is designed to accrue 420 patients if it continues to full accrual. The company believes that full accrual to the trial can be completed by late 2007 or early 2008. Ann Cahill, vice president, clinical development of Vion said, "We are proud to have reached the halfway point of accrual to our phase III trial of Cloretazine (VNP40101M). Together with our pivotal phase II trial of Cloretazine (VNP40101M) as a single agent in elderly patients with de novo poor-risk AML, our phase III trial represents an important evaluation of Cloretazine (VNP40101M)'s role in the treatment of AML, a life threatening disease for many people."
Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercialising innovative cancer therapeutics. Vion has two agents in clinical trials. Cloretazine (VNP40101M), a unique alkylating agent, is being evaluated in phase III trial in combination with cytarabine in relapsed acute myelogenous leukaemia and phase II pivotal trial as a single agent in elderly patients with previously untreated de novo poor-risk acute myelogenous leukaemia. Additional trials of Cloretazine (VNP40101M) as a single agent in paediatric brain tumours, small cell lung cancer, and in combination with temozolomide in haematological malignancies, are also underway. Triapine, a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute. In preclinical studies, Vion is also evaluating VNP40541, a hypoxia-selective compound. The company also is seeking development partners for Tapet, its modified Salmonella vector used to deliver anticancer agents directly to tumours.