To: Jibacoa who wrote (3469 ) 4/19/2001 10:03:11 PM From: Scott H. Davis Read Replies (1) | Respond to of 52153 "fraid VICl may well be dd down manana. Not only was it overbought after a significant runnup, it's the 1st adverse news in 4 years. Will bring on some profit taking. News not too bad given the fact that it was not their 1st or 2nd most important therapeutic, and the preventatives side is continuing to progress pretty well. IMSCO Scott siliconinvestor.com Bernard, and thoughts on a retrace point? Given the current positive market climate & good recent news, I'm thinking 14quote.yahoo.com ical Updates Leuvectin(TM) Kidney Cancer Program SAN DIEGO, April 19 /PRNewswire/ -- Vical Incorporated (Nasdaq: VICL - news) today announced that the company is discontinuing the current Phase II clinical trial with Leuvectin(TM) for patients with metastatic kidney cancer and planning a new Phase II clinical trial using a new dose and dosing regimen. In the current Phase II kidney cancer trial with Leuvectin(TM), the study protocol required an interim analysis of data from the first 37 patients. Based on that analysis, the company determined that efficacy failed to meet the level needed to continue the study. The efficacy also appears to be lower than that observed in prior kidney cancer trials with Leuvectin(TM). The Leuvectin(TM) used in the current trial was formulated with a different process than the Leuvectin(TM) used in earlier trials. Comparative analysis suggests that expression of interleukin-2 (IL-2) for the product used in the current trial may be below historical levels. The new trial would use high-dose Leuvectin(TM) formulated with an optimized process. ``Clinical testing is intended to identify such issues,'' said Vijay B. Samant, Vical's President and Chief Executive Officer, ``and our internal systems worked as designed in doing so. The safety profile for Leuvectin(TM) has been excellent compared with systemic IL-2 therapy and efficacy results from our earlier trials were promising.'' The safety database for Leuvectin(TM) now includes more than 235 patients, with less than 3 percent requiring even brief hospitalization for drug-related adverse events. The drug-related hospitalization rate for systemic IL-2 therapy is significantly higher. ``We are confident,'' added Mr. Samant, ``that continued development of Leuvectin(TM) can lead to a better treatment option for patients with metastatic kidney cancer.'' Leuvectin(TM) The active ingredient in Leuvectin(TM), a DNA-based product candidate, is a gene encoding IL-2, a naturally occurring protein that stimulates the immune system. Administration occurs by direct injection into a tumor, leading to uptake by the tumor cells and subsequent expression of the IL-2 protein. The company expects that local expression of IL-2 by cancer cells may stimulate the patient's immune system to attack and destroy the tumor cells. Recombinant IL-2 protein is an FDA-approved anti-cancer agent for the treatment of advanced kidney cancer. When given systemically, it is frequently associated with serious side effects. Because Leuvectin(TM) delivers IL-2 locally within the tumor, it may provide similar benefits with fewer side effects than the systemic protein therapy. Vical Incorporated, The Naked DNA Company(TM), is focused on the development of pharmaceutical product candidates based on its patented gene delivery technology. A number of therapeutic and vaccine product candidates are currently under development for the prevention or treatment of cancer, infectious diseases and metabolic disorders by Vical and its collaborative partners, including Merck & Co., Pfizer Inc., Aventis Pasteur, Aventis Pharma, Human Genome Sciences, Centocor Inc., Merial and Boston Scientific Corporation. Allovectin-7®, which uses a lipid-DNA complex to help the immune system recognize and attack cancer cells, is in Phase II and Phase III testing in certain patients with metastatic melanoma and in Phase II testing in patients with head and neck cancer. Leuvectin(TM), which uses a lipid-DNA complex to stimulate an immune response against cancer cells, is in Phase II testing in patients with kidney cancer and prostate cancer. Vaxid, a naked DNA vaccine to prevent relapse of B-cell lymphoma, is in Phase I/II testing. In collaboration with the National Cancer Institute, a naked DNA vaccine to treat metastatic melanoma is in Phase I/II testing. If you are interested in any of Vical's clinical trials, please see our website at www.vical.com, or contact Tammy Boyce by phone at 858/646-1120 or by e-mail at tboyce@vical.com.