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Biotech / Medical : Vion (formerly Oncorx) interesting play on Gene Therapy -- Ignore unavailable to you. Want to Upgrade?

To: Jim Oravetz who wrote (225)	2/20/2001 12:43:07 PM
From: Dave	Respond to of 370

The Phase I clinical trial of VNP40101M sounds like good news. So why is VION stock suddenly plummeting today? Is this just a broad biotech slump or does the market know something I don't about today's announcement? Dave

To: Jim Oravetz who wrote (225)	2/21/2001 10:17:30 PM
From: Jim Oravetz	Respond to of 370

Commenting on the company's 2000 results, Alan Kessman, president and chief executive officer of Vion, stated, "The year 2000 was one in which we significantly advanced our business agenda on all fronts. During the year, we advanced our preclinical and clinical development activities related to all three of our technologies. Specifically, we made progress in our Phase I studies of both TAPET(R) and Triapine(R) and completed all preclinical and toxicology work on our Sulfonyl Hydrazine Prodrugs. From a corporate standpoint, we greatly simplified the company's capital structure and strengthened the balance sheet through a series of warrant exercises and other stock transactions, resulting in net proceeds to the company of approximately $26.2 million." Mr. Kessman concluded, "With several notable milestones reached, we begin the year 2001 as a much stronger company, with a stable of three product technologies, all in some stage of clinical development, important collaborations with which to expand our knowledge base and cash resources of approximately $24.4 million, which based on our current initiatives will fund the company's development efforts through the first quarter of 2002."

To: Jim Oravetz who wrote (225)	2/21/2001 10:19:26 PM
From: Jim Oravetz	Read Replies (1) \| Respond to of 370

NEW HAVEN, FEB 20 - VION today announced that it will proceed with a Phase I human clinical trial of the lead candidate VNP40101M from its Sulfonyl Hydrazine Prodrug (SHP) family of novel and potent alkylating (DNA-damaging) agents, and that the Investigational New Drug (IND) application for VNP40101M, which was submitted to the Food and Drug Administration in January, is active as of February 10, 2001. The trial, which will assess the product's safety and maximum tolerated dose, is expected to begin in approximately 2 months and to enroll 20-30 patients. Alkylating agents are important components of several standard treatment regimens for cancer. The individual properties of an alkylating agent determine its pattern of activity and toxicity and therefore its clinical application. Preclinical studies of VNP40101M indicated unique and advantageous features, which could lead to an enhanced spectrum, or improved antitumor activity, compared to the standard available alkylating agents. For example, in addition to damaging DNA, VNP40101M also inhibits a key enzyme (AGT) involved in the repair of the DNA damage. Thus, it blocks a major mechanism of drug resistance common to several of the standard alkylating agents. VNP40101M also exhibited excellent penetration across the blood brain barrier in mice, and a high degree of antitumor activity against intra-cranially implanted leukemia cells. The latter distinguishes VNP40101M from many anticancer agents that have difficulty penetrating into the brain, a site where primary tumors can occur and a common site of metastases for several other solid tumors. Overall, VNP40101M demonstrated a broad spectrum of antitumor activity in preclinical animal models, including activity against tumor cells that are resistant to several of the alkylating agents in common use today. Alan Sartorelli, Ph.D., Professor of Pharmacology at the Yale University School of Medicine, a member of Vion's Board of Directors and Scientific Advisory Board, and lead scientist in the initial discovery and development of the SHP family of agents, stated, " VNP40101M is among the most active anticancer agents we have tested in animal models. Not only does it inhibit a common mechanism of resistance to certain standard alkylating agents, the DNA damage that it causes is difficult to detect by the tumor cell 's repair mechanisms. I am excited by the prospects for this agent to provide benefit to patients with cancer." Alan Kessman, president and CEO of Vion, stated, "The expertise of our preclinical biology and development groups is demonstrated by the speed with which we completed formulation and toxicology studies on VNP40101M and submitted a successful IND application to the FDA. We are very excited about VNP40101M from the perspective of its potential contribution to cancer patients and the additional strength and diversity it gives Vion as a company. In addition to the TAPET'r' bacterial vector and Triapine'r', VNP40101M will be the third agent that Vion is developing for the treatment of cancer. All three of these agents have the potential to be effective against many different types of cancer." 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 and Sulfonyl Hydrazine Prodrugs). TAPET uses genetically altered strains of Salmonella as a bacterial vector, or vehicle, for delivering cancer-fighting drugs preferentially to solid tumors and is currently being evaluated for safety and colonization in several Phase I trials. 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 several Phase I clinical trials. VNP40101M is a member of the Sulfonyl Hydrazine Prodrug class, compounds that are designed to be converted to unique potent, alkylating agents and is expected to begin Phase I trials for safety within the next two months.