Vion To Begin PIII Trail For Cloretazine(Spring '05) + other news - tapet is dead, Sznol to leave post.
DOW JONES NEWSWIRES
September 23, 2004 5:10 p.m.
NEW HAVEN, Conn. -- Vion Pharmaceuticals Inc. plans to begin Phase III trials for its leukemia drug cloretazine and will expand a pancreatic cancer study and add more patients in its triapine trial.
In a press release Thursday, the developer of cancer treatments said it plans to begin Phase III trials for cloretazine in the first quarter of 2005, based on the drug's activity in treating acute myeloid leukemia in a Phase I and ongoing Phase II trial.
Vion said it will extend its pancreatic cancer study and enroll 25 to 35 patients on longer infusions of triapine.
Patients in the pancreatic cancer trial received at least a single dose of treatment in the study. As of Sept. 1, with a median follow-up for survival of 6.6 months, the objective rate was 3.3%, median progression-free survival was 3.9 months, and median survival was 8.75 months.
Patients in the lung cancer trial had received a minimum of one, but not more than two prior regimens of cytotoxic chemotherapy. Seven patients were recently entered on the trial and are not yet evaluable for response. The response rate among the remaining 38 patients was 5.3%. As of Sept. 1, with a median follow-up for survival for all 45 patients of four months, median progression-free survival was 2.1 months, and median survival was 6.8 months.
Preclinical data show that the interaction of triapine with gemcitabine is optimized by increasing the duration of the triapine exposure to 24 hours from four hours.
The company said it is encouraged by the preliminary data on median survival in the pancreatic cancer trial and wants to continue to investigate the triapine-gemcitabine combination in this indication.
Beijing Pason Pharmaceuticals, Vion's development partner in China, Taiwan, Macao and Hong Kong, plans to initiate clinical trials of triapine in China in 2005.
Vion said it plans to file an investigational new drug application for KS119 in 2005. This compound has shown a high level of selectivity for activation under hypoxic, or low oxygen, conditions, which are present generally only in tumor tissue.
With respect to tapet, the company has recently closed accrual to its study of a second-generation vector in dogs. After review of the data from this study, Vion said the time and cost of continued internal development of tapet is more than it can support with its own resources in the near-term. Therefore, the company plans to seek a partner for future development of this technology.
Vion also said Mario Sznol will step down as vice president of clinical affairs on Oct. 15 to pursue early cancer drug development for patients with melanoma at Yale University Medical School. Sznol will consult for the company as special adviser for clinical affairs and become a member of Vion's scientific advisory board.
The company is recruiting a full-time chief medical officer with late-stage development and commercialization skills.
Shares of Vion traded recently at $4 after hours, according to INET, after closing the regular session at $4.05, down 12 cents, or 2.9%.
Company Web site: vionpharm.com |
