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Phase 2 Trial of Cloretazine Initiated, Undergoing Investigation in Small Cell Lung Cancer

NEW HAVEN, Conn., Sept. 20 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (NASDAQ:VION) announced today that it had initiated a Phase II clinical trial of its anticancer agent Cloretazine(R) in small cell lung cancer. The objectives of the study are to determine the response rate and toxicity of Cloretazine(R) 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.

Dr. Howard Burris, investigator at the Sarah Cannon Cancer Center in Nashville, Tennessee, commented, "We are excited to be offering this promising new therapy to our patients with small cell lung cancer. Innovative therapies are needed for this difficult-to-treat patient population."

According to the American Cancer Society, lung cancer is the leading cause of cancer death, and patients with small cell lung cancer represent approximately thirteen percent of all lung cancer patients. 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.

Alkylating agents have demonstrated activity in small cell lung cancer, and are often used as second-line treatment following cisplatin-based combinations. Cloretazine(R) is a novel DNA-damaging alkylating agent with broad spectrum anti-tumor activity in preclinical studies. Two Phase I trials have investigated the safety profile, maximum tolerated dose, and schedule for Cloretazine(R) in solid tumors. This new trial in small cell lung cancer is a multi-center Phase II study that expects to enroll up to approximately 90 patients.

Ann Cahill, Vice President, Clinical Development, stated, "We are pleased to expand our solid tumor clinical development program for Cloretazine(R) with the initiation of this study."

Source: Vion Pharmaceuticals, Inc.

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