VION PHARMACEUTICALS (OTC:VION)
Industry: Healthcare
Vion Pharmaceuticals, Inc., incorporated in March 1992, is a development-stage pharmaceutical company engaged in the development of therapeutics for the treatment of cancer. Its portfolio of potential products consists of two distinct small molecule anticancer agents in clinical development, and additional small molecules in preclinical development. The Company also has developed a drug delivery technology for the treatment of cancer. Vion Pharmaceuticals' product development programs are based on technologies that it licenses from Yale University and other cancer research centers. The Company has largely engaged in product development with respect to anticancer therapeutics through in-house preclinical and clinical development, and through collaboration with academic, research and governmental institutions. Products in Clinical Development Its lead product, Cloretazine (VNP40101M), is an alkylating (deoxyribonucleic acid (DNA)-damaging) agent. The Company's primary registration strategy for this compound is for the treatment of acute myelogenous leukemia (AML). A Phase III trial of Cloretazine in combination with cytosine arabinoside (Ara-C) in relapsed AML commenced in March 2005. In January 2006, Vion Pharmaceuticals announced that it will conduct a pivotal Phase II trial in elderly patients with de novo poor-risk AML. This trial is expected to commence in 2006. In addition to these two trials in AML, Cloretazine is being evaluated in clinical trials as a single agent in chronic lymphocytic leukemia, small cell lung cancer and adult and pediatric brain tumors, and in combination with temozolomide in advanced hematologic malignancies. Cloretazine has received two fast track designations from the United States Food and Drug Administration (FDA) for the treatment of relapsed AML and elderly poor-risk AML. Cloretazine has also received orphan drug designation for the treatment of AML in the United States and the European Union. The Company's second clinical compound, Triapine, is a small molecule that in preclinical models inhibits the enzyme ribonucleotide reductase, and therefore prevents the replication of tumor cells by blocking a critical step in DNA synthesis. Intravenous Triapine is being evaluated in Phase I and Phase II single agent and combination clinical trials sponsored by the National Cancer Institute (NCI). The NCI is also expected to sponsor a Phase I clinical trial of an oral formulation of Triapine, which should be initiated in 2006. In October 2003, the Company entered into a license with Beijing Pason Pharmaceuticals, Inc., (Pason) whereby it granted Pason the rights to develop, manufacture and market Triapine in the People's Republic of China, Taiwan, Hong Kong and Macao. Products in Preclinical Development VNP40541 (formerly called KS119W) is an additional cytotoxic (cell-damaging) compound from the sulfonylhydrazine class. VNP40541 has been demonstrated in preclinical studies to be highly selective for hypoxic (poorly oxygenated) cells, which are found in tumors and are often hard to treat with conventional anticancer agents. Vion Pharmaceuticals plans to file an investigational new drug (IND) application and commence a Phase I trial of VNP40541 in 2006. Heterocyclic hydrazones are anticancer compounds that have demonstrated potent anti-tumor effects in preclinical studies. The mechanisms of action for these compounds are unidentified at this time. In December 2003, the Company entered into a research collaboration and option agreement related to these compounds with a group of inventors from the Institute of Pharmacy and the Institute of Medicinal Chemistry and Biochemistry at the University of Innsbruck, and Austria Wirtschaftsservice Gesellschaft m.b.H, a bank specializing in Austrian business promotion. In September 2005, Vion Pharmaceuticals entered into a license for these compounds. The Company plans to evaluate heterocyclic hydrazones in preclinical studies in 2006. Drug Delivery Technology Tumor Amplified Protein Expression Therapy (TAPET), the Company's drug delive
As Of: 10/07 00:00 ET
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