NEW HAVEN, CT, MAY 18, 2000 - VION PHARMACEUTICALS, INC. (NASDAQ NM: VION) today announced it initiated an additional Phase I study of Triapine® to assess the safety and maximum tolerated dose when administered intravenously, by continuous infusion, over a 96-hour period. The trial will be conducted at the Albert Einstein College of Medicine/Montefiore Medical Center, Bronx, New York, under the direction of Drs. Scott Wadler and Della Makower.
This new study follows the completion of a Phase I single dose study of Triapine, which demonstrated its safety profile and ability to reach pharmacologically relevant serum concentrations. The current trial, and an ongoing study of short infusions administered daily for 5 days, will continue to evaluate the safety profile and feasibility of extending injections of Triapine over several days, which, in preclinical animal tumor models, demonstrated Triapine's greatest antitumor activity.
Triapine is a potent ribonucleotide reductase inhibitor that blocks a critical step in the synthesis of DNA, thereby preventing the replication of tumor cells. Vion plans to develop Triapine as a potential treatment for solid tumors and acute myelogenous leukemia. In preclinical studies, Triapine exhibited significant in vitro and in vivo activity against human ovarian cancer grafted onto mice and in mouse tumors for leukemia and lung cancer.
Alan Kessman, president and CEO of Vion, commented, "We are pleased to collaborate with the Albert Einstein College of Medicine/Montefiore Medical Center on the development of Triapine. Dr. Wadler and his colleagues are accomplished clinical investigators and bring their substantial expertise to this project. Our experience so far indicates that one or both of the extended Triapine schedules may be well-tolerated and feasible for evaluation in Phase II studies. Furthermore, the Phase I studies will set the stage to begin studies of Triapine in combination with traditional anticancer agents, where, in preclinical models, we have observed improvement in antitumor activity compared to administration of the single agents. The data suggest that Triapine could be combined successfully with many of the standard cancer treatment regimens, and thus, will have broad clinical utility."
Vion Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the research, development and commercialization of cancer treatment technologies. Vion's product portfolio consists of TAPET®, a drug delivery platform, and three cancer therapeutics (Promycin®, Triapine and Sulfonyl Hydrazine Prodrugs). TAPET has been shown in preclinical models to effectively deliver anticancer agents while having a minimal toxic effect on healthy normal tissues. TAPET uses genetically altered strains of Salmonella as a bacterial vector, or vehicle, for delivering cancer fighting drugs preferentially to solid tumors. Promycin, which attacks oxygen depleted cancer cells, is currently being evaluated with radiation in a multicenter Phase III clinical trial for the treatment of head and neck cancer. Triapine, which is designed to prevent the replication of tumor cells by blocking a critical step in the synthesis of DNA, is currently being evaluated for its safety in Phase I clinical trials. Sulfonyl Hydrazine Prodrugs, compounds that are designed to be converted to unique potent, alkylating agents, are currently being evaluated in preclinical studies. For additional information on Vion and its research and product development programs, visit the company's Internet web site at http://www.vionpharm.com.
Statements included in this press release which are not historical in nature are forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements regarding the company's future business prospects, plans, objectives, expectations and intentions are subject to certain risks, uncertainties and other factors that could cause actual results to differ materially from those projected or suggested in the forward-looking statements, including, but not limited to those contained in the company's Registration Statement filed on Form S-3/A (file no. 333-95671). The shares of Common Stock, described above, have not been registered under the Securities Act of 1933, as amended, and may not be offered and sold in the United States absent registration under such Act or an applicable exemption from registration. This press release shall not constitute an offer to sell or the solicitation of an offer to buy its securities nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
COMPANY CONTACT: Vion Pharmaceuticals, Inc.
Alan Kessman, President and CEO
Thomas E. Klein, VP Finance & CFO
(203) 498-4210 ph
FINANCIAL COMMUNICATIONS CONTACT: CPR Financial Communications, LLC
Sue L. Yeoh (investors)
(201) 641-2408 ph
Lisa Bradlow (media)
(212) 579-7428 ph