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Press Release, Monday June 25, 2001 Vion Pharmaceuticals, Inc.
Patient Enrollment Begins in First Phase I Clinical Trial of Vion´s Sulfonyl Hydrazine Prodrug Anticancer Agent
Vion Pharmaceuticals, Inc. today announced initiation of the first Phase I clinical trial of its Sulfonyl Hydrazine Prodrug (SHP) VNP40101M, an anticancer alkylating agent that has demonstrated broad anti-tumor activity in preclinical studies. The multi-center study is being conducted at the West Haven Veterans Administration Hospital in Connecticut, the Yale Cancer Center in New Haven, Connecticut, and the Arizona Clinical Research Center in Tucson. Approximately 20-30 patients are expected to enroll in the trial, which is designed as a dose-escalation study to determine the safety profile of the agent and the maximum tolerated dose for future trials.
Preclinical studies demonstrated that VNP40101M had anti-tumor activity against selected tumor cell lines that were resistant to the effects of several alkylating (DNA-damaging) agents that are components of current standard cancer treatments. VNP40101M also showed activity against several different tumor types in mice. The broad spectrum of activity is explained in part by the ability of VNP40101M to inhibit a key enzyme (AGT) involved in the repair of the DNA damage, making it more difficult for cancer cells to develop resistance. VNP40101M also demonstrated an ability to cross the blood-brain barrier, which blocks entry of most drugs into the brain and therefore limits effective treatment of tumors in the brain.
"VNP40101M is Vion´s third anticancer agent and our first clinical candidate from the SHP class of novel alkylating agents," said Dr. Mario Sznol, Vion´s VP for Clinical Development. "Alkylating agents have proven efficacy in the treatment of certain types of cancers, and the preclinical data suggest that VNP40101M has distinct advantages over existing agents and therefore may eventually lead to improved treatment for some patients."
Vion Pharmaceuticals, Inc. is a biotechnology company developing novel agents for the treatment of cancer. Vion´s portfolio of agents includes TAPET®, a modified Salmonella vector used to deliver anticancer agents directly to tumors, currently in Phase I trials; Triapine®, a potent inhibitor of a key step in DNA synthesis and repair, currently in Phase I combination studies and scheduled for Phase II single agent trials; and VNP40101M, a unique DNA alkylating agent now in Phase I clinical trials.