NEW HAVEN, CT, March 28, 2000 - Vion Pharmaceuticals, Inc. (NASDAQ NM: VION) announced today it has received approval to begin a Phase I human clinical trial of Vion's first TAPET® bacterial vector at the National Cancer Institute (NCI), Bethesda, Maryland and signed a Letter of Intent for a five-year Cooperative Research and Development Agreement (CRADA) with the NCI. The Phase I trial is designed to determine the safety and tolerability of intravenously injected TAPET in patients with advanced cancer that has progressed despite best available therapy. Additionally, the trial is expected to provide information regarding TAPET's ability to penetrate and preferentially replicate within tumor metastases. Both clinical and subsequent preclinical studies will be conducted under the direction of Steven A. Rosenberg, M.D., Ph.D., Chief of Surgery in the Division of Clinical Sciences of the NCI, a renowned cancer researcher and a leading authority on the application of cytokines, tumor vaccines and other biologicals in cancer patients.
TAPET is the designation for Salmonella bacteria that have been genetically altered to reduce or prevent the usual consequences of infection. In extensive preclinical studies, TAPET bacteria have been shown to accumulate preferentially in tumors and inhibit their growth. Scientists at both VION and Yale University have demonstrated the antitumor activity of TAPET in mouse models. Toxicology studies have been conducted in several species including monkeys, and these studies have shown that administration of high doses of TAPET is safe and well tolerated.
Under the terms of the CRADA, Vion scientists will provide Dr. Rosenberg's laboratory with a variety of TAPET vectors for further evaluation. The proposed CRADA would allow Dr. Rosenberg to evaluate VNP20009 in a variety of additional murine models and potentially in combination with other anticancer agents, as well as to further explore the mechanisms by which the bacterial vectors cause antitumor activity. Upon execution, the CRADA would also enable future preclinical studies of second generation armed TAPET vectors (bioengineered to express certain potent anticancer agents) and clinical trials that are predicated on the antitumor activity demonstrated in mouse models.
Commenting on the agreement, Alan Kessman, president and CEO of Vion, noted, "This a first step in forming a long-term collaboration with the National Cancer Institute to further evaluate and expand upon TAPET's potential, representing an important stride for our TAPET program and the company. The initiation of this Phase I intravenous trial represents a major milestone for Vion, and under Dr. Rosenberg's supervision, the NCI provides an excellent setting to evaluate the safety and biologic effects of our first TAPET product. We are hopeful that the trial will provide proof of the TAPET bacteria's ability to localize and preferentially replicate within disseminated cancer throughout the body. Furthermore, successful completion of this study will provide a solid foundation to develop the first generation of TAPET ('unarmed') as a potential treatment for patients with advanced solid tumors alone or in combination with standard anticancer agents.
"Assuming the Phase I tests demonstrate the ability of the TAPET bacteria to accumulate preferentially in tumor tissue, we plan to develop future TAPET agents ('armed') that are engineered to deliver therapeutic peptides and proteins with potentially greater antitumor activity. TAPET is expected to essentially become a Œdrug factory' directly within tumors, producing the anticancer agents in high concentrations for extended periods of time. The localized production of anticancer agents at high concentrations within tumor is expected to improve the therapeutic ratio, and as a result, increase antitumor efficacy with acceptable levels of toxicity," concluded Mr. Kessman.
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 a Phase I clinical trial.
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 Vion Pharmaceutical's Registration Statement filed on Form S-3/A (file no. 333-95671). This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities of the Company 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.