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SOURCE: Vion Pharmaceuticals, Inc.
VION Initiates Phase I Intravenous (IV) Human Clinical Trial of Anticancer Platform TAPET(R) at the Royal Marsden NHS Trust in the United Kingdom
- Company Expands Clinical Trials of TAPET to Europe -
NEW HAVEN, Conn., July 24 /PRNewswire/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION - news) announced today the initiation of a Phase I human clinical trial of its TAPET® bacterial vector (Tumor Amplified Protein Expression Therapy) at The Royal Marsden Hospital, in Sutton, England. This is the first study of TAPET to be conducted in Europe and the second trial to administer the bacterial vector by intravenous route. The study is expected to enroll up to 48 patients. Ian Judson, M.D., F.R.C.P., Clinical Pharmacology Unit, will serve as the principal investigator. The Royal Marsden NHS Trust is the UK's leading comprehensive cancer center. It operates from two sites -- Chelsea, London and Sutton, Surrey. Over 30,000 patients receive treatment at The Royal Marsden each year, having been referred from all over the UK and abroad.
Vion is conducting Phase I trials of TAPET administered intravenously or injected directly into tumors near the surface of the body. The studies are designed to determine the safety and tolerability of TAPET in a broad group of patients with advanced cancer, and to provide information regarding TAPET's ability to penetrate and preferentially replicate and accumulate within tumors of selected patients. This Phase I study in the UK follows a Phase I intravenous trial currently being conducted at the National Cancer Institute, in Bethesda, Maryland, which began in March 2000.
Alan Kessman, president and CEO of Vion, noted, ``This first trial of TAPET in England reflects Vion's intent to extend its clinical development program to Europe. We are pleased to be collaborating with Dr. Judson and The Royal Marsden Hospital, both of which are well-respected and experienced in the area of clinical cancer research. The breadth of our Phase I trials is intended to establish the safety and preferential tumor accumulation of TAPET, which will set the stage for further exploration of the antitumor activity of the base TAPET vector and for entry into clinical trials of the armed TAPET vectors.''
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, inhibiting 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. Vion scientists have also demonstrated the capacity of the Salmonella in preclinical studies to carry and express genes coding for therapeutic anticancer agents, thus permitting the delivery of the anticancer agents to tumors in high concentrations while avoiding toxicity to normal tissues. The company recently received a U.S. patent on its TAPET technology, which covers the pharmaceutical composition and method of use of Salmonella for the inhibition of growth and/or reduction of volume in solid tumors when administered in vivo.
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 cancer therapeutics (Triapine (R) 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. 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 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. 333-79939). This press release shall not constitute an offer to sell or the solicitation of an offer to buy the common stock 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.
CONTACT: Alan Kessman, President and CEO, or Thomas E. Klein,
VP Finance & CFO, both of Vion Pharmaceuticals, 203-498-4210;
or Sue L. Yeoh, investors, 201-641-2408, or Lisa Bradlow,
media, 212-579-7428, both of CPR Financial Communications, LLC
SOURCE: Vion Pharmaceuticals, Inc. |
