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To: LANCE B who wrote (1861)	7/23/1998 8:04:00 AM
From: Winthrop Troy	Respond to of 4028

ISIS PHARMA DRUG IS THE FIRST ANTISENSE DRUG APPROVED BY THE FDA! this ads huge credibility to the anti-sense market and CYGS will move

To: LANCE B who wrote (1861)	7/23/1998 8:07:00 AM
From: Winthrop Troy	Respond to of 4028

WASHINGTON (Dow Jones)-- Isis Pharmaceuticals Inc. (ISIP) won support from a federal panel for its drug Vitravene as a treatment for an infection that causes blindness in people with AIDS. If approved by the U.S. Food and Drug Administration, Vitravene will be the first drug of the so-called "antisense" class cleared by the agency. Analysts have said approval of this new class of drugs, which are created from DNA coding, will be a huge step not only for Isis, but for the biotechnology community. The FDA usually follows the advice of its outside expert panels. Isis, and its Vitravene marketing partner Novartis AG-unit CIBA Vision Corp., filed its Vitravene new drug application with the FDA last April. The FDA designated the drug for expedited review, meaning it plans to make a final decision on Vitravene within six months of Isis' filing because the drug may be a breakthrough in treating a serious condition. Vitravene treats cytomegalovirus, or CMV, retinitis which is an opportunistic infection that permanently destroys the retina in patients with AIDS. Dr. Daniel Kisner, Isis' president and chief operating officer, said in the U.S. there are about 7,000 to 10,000 cases of CMV retinitis. In its presentation before the panel Isis said it studied 430 eyes, which represented 230 patients. Isis said its studies showed Vitravene slowed down progression of CMV retinitis. Dr. Wiley Chambers, who reviewed the data for the FDA, said there weren't enough patients studied. Although the FDA and Isis agreed on the number of patients to be included in the clinical trials, Chambers said Isis submitted its application for Vitravene before the established number of patients were enrolled. "Most studies were presented prior to scheduled completion and that was problematic," Chambers said. "The studies should have been completed as originally designed." Chambers said he wasn't able to evaluate some of the patients because pictures taken of their retinas weren't clear. A. Paul Boni, a research analyst who follows Isis for Punk, Ziegel & Co., said if the FDA ultimately approves Vitravene it will set a "nice precedent" for the company's other antisense drugs that could have a greater financial impact. Boni said Vitravene could have annual U.S. sales of $12 million. Steven Delco, an analyst who follows Isis, agreed that other drugs will impact the company more. "They have a very good pipeline of products," Delco said. "Their next group of targets will be for inflammatory diseases, including Crohn's disease. That is where we think they will really start to make money." - By Otesa Middleton 202-862-6654 (END) DOW JONES NEWS 07-22-98 03:08 PM