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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: IN_GOD_I_TRUST who wrote (2093)	7/22/1998 3:03:00 PM
From: Mailbu	Read Replies (2) \| Respond to of 4676

Isis Drug Wins Panel Nod for AIDS-Related Eye Ailment (Update2) (Adds panel action) Bethesda, Maryland, July 22 (Bloomberg) -- Isis Pharmaceuticals Inc.'s Vitravene is safe and effective for use in staving off the eye damage a common infection can cause in late- stage AIDS patients, an expert government panel said. In a series of votes, the advisory panel for the Food and Drug Administration recommended the full agency approve the drug, known chemically as fomivirsen. The FDA doesn't have to follow the advice of its expert panels but it usually does so. ''What is more important, in the end, than having your visual acuity preserved?'' said John Chandler, a medical doctor and eye specialist who presented data on the Isis drug. ''I believe that this is a drug that has an important place in the management'' of the infection, known as CMV retinitis, he said. CMV, or cytomegalovirus, attacks many organs in the body but has its most dramatic effects on the eyes, and can cause loss of vision within weeks if left untreated. The panel is still voting on whether the drug's use should be limited to patients who have not improved using existing treatments. Shares in the company were halted while the panel deliberated. The panel backing is a strong vote of confidence in the drug, and in Isis' technology. In voting to recommend the drug, panel members said they were convinced by the company's data even though it came from only a handful of patients. Infection Declining Effective combination HIV therapies have led to a sharp drop in full-blown AIDS cases, and a corresponding decline in the rate of opportunistic infections. While CMV retinitis is one of the most common infections to ravage AIDS patients who have completely lost their immune systems, the company was unable to find enough patients to complete its series of trials designed to support an approval. During the course of the company's trials, CMV became ''distinctly rare'' company officials said, and data presented today was based on results from 82 patients. And while FDA reviewer Wiley Chambers said he thought the drug was likely having a good effect on at least some patients, he urged caution in making decisions based on such scant information. ''It only takes a couple of patients being (evaluated) slightly differently. . . to have a tremendous impact,'' he said. ''There was too much variability for me to be able to tell what was going on.'' Anti-Sense Technology Far more important than the potential for sales -- which are expected to be negligible -- an approval would be a milestone for Carlsbad, California-based Isis because it would help validate what has been considered a risky and complex theory of drug design called ''anti-sense'' technology. Vitravene would be the first in this entirely new class of drugs, and would be the first FDA approval for the company. ''It's an important milestone in the development of the company'' which largely invented the approach, said David Stone, an analyst with SG Cowen & Co. ''There is a skepticism out there about 'anti-sense' because of failed experiments by other companies and academics,'' that would be changed by an approval, Stone said. ''When you get something all the way through the FDA and on the market you have to take it seriously.'' Researchers for the company presented data they said showed the drug, given by an injection directly into the eye, is safe and works to fight the blinding infection. In the 82 patients, the drug significantly lengthened the amount of time before eye lesions worsened. Side effects were minimal. Isis' strategy involves mapping out the genetic code responsible for a disease beforehand, rather than relying on trial and error. Then anti-sense technology allows Isis to reverse-print the virus gene codes, and home in on a precise section to block it. The reverse printed gene sequence binds to the gene section which would trigger disease activity, like filling the grooves of a key so it no longer works in a lock. While the theory is attractive, critics have said results from the company's trials may be due to inactive ingredients in the injections. They maintain the genetic material contained in Vitravene is more likely to be destroyed by the body than to reach the portions of the eye where CMV hides out. If the FDA clears the drug, it would be marketed by Novartis AG's Ciba Vision unit. It would compete with treatments made by Gilead Sciences Inc., Chiron Corp., Roche Holding AG and Astra AB.