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Promycin Phase III Clinical Trial for New Cancer Treatment Expanded NEW HAVEN, Conn.-- Nov. 20, 1996 -- Vion Pharmaceuticals Inc. (NASDAQ:VION) today announced the expansion of a pivotal Phase III clinical trial of their anticancer agent Promycin(TM) (porfiromycin). With the trial expansion, Promycin is expected to be investigated at eight sites in the United States for the treatment of head and neck cancer. "The expansion of the Phase III clinical trials is a major milestone for Vion, as it is designed to obtain marketing approval for Promycin in the U.S." said John A. Spears, president and chief executive officer. "We believe Promycin will be an important drug in the treatment of head and neck cancer as well as potentially other tumor types, for which future trials are planned." The Phase III head and neck cancer trial compares standard radiation therapy to Promycin plus radiation therapy. In the trial, Promycin is administered as an i.v. injection during the six-week course of radiation therapy. The study is designed to accrue 200 patients and is being managed by ILEX(TM) Oncology, a drug development organization in San Antonio, Texas which focuses on the development of anticancer compounds. Promycin is a therapeutic for hypoxic (oxygen-depleted) cancer cells, which are known to be less susceptible to radiation therapy than other tumor cells. In a Phase I/II clinical trial, the combination of Promycin and radiation therapy produced a 33% disease-free survival rate at five years among the participants, who suffered from head and neck cancer. The rate exceeded the expected survival rate in such patients. Vion has obtained Orphan Drug status for Promycin in the treatment of head and neck cancer, giving the compound seven years of marketing exclusivity following regulatory approval in the United States. Vion is currently in the process of initiating clinical trials in Europe. Vion Pharmaceuticals is a biopharmaceutical company dedicated to discovering, developing and commercializing oncology and antiviral products. E-mail this page to a friend or colleague! To print, use this version