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www.fdanews.com/articles/81039-vion-initiates-trial-of-cloretazine-for-small-cell-lung-cancer

VION INITIATES TRIAL OF CLORETAZINE FOR SMALL CELL LUNG CANCER

September 20, 2005

Vion Pharmaceuticals has initiated a Phase II clinical trial of its anticancer agent Cloretazine in small cell lung cancer. The objectives of the study are to determine the response rate and toxicity of Cloretazine in patients with locally advanced or metastatic small cell lung cancer who have either not responded to or relapsed following initial treatment for the disease.

Small cell lung cancer is frequently responsive to initial chemotherapy, but recurs quickly and remains difficult to treat with standard drugs. Patients with small cell lung cancer who do not respond to standard treatment, or who suffer a relapse after treatment, have a poor prognosis and are appropriate candidates for investigational drugs.

Cloretazine is a novel DNA-damaging alkylating agent with broad-spectrum antitumor activity in preclinical studies. Two Phase I trials have investigated the safety profile, maximum tolerated dose, and schedule for Cloretazine in solid tumors. This new trial in small cell lung cancer is a multicenter Phase II study that expects to enroll up to approximately 90 patients.