Subject: Gilead Sciences Poised to Begin Clinical Tests Date: Published: 3/19/92 (67 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Technology & Medicine: Gilead Sciences Poised to Begin Clinical Tests ---- By Marilyn Chase Staff Reporter of the Wall Street Journal Gilead Sciences Inc., one of the pioneer companies seeking to thwart the activity of disease-causing genes, is poised to take its first product into the clinic. Gilead, based in Foster City, Calif., yesterday filed an investigational new drug application with the Food and Drug Administration covering a new drug for the treatment of AIDS-related blindness. The FDA's response typically comes within 30 days, after which the company may launch human tests. Gilead's president and chief executive officer, Michael L. Riordan, said the compound GS504 is the first of a suite of experimental new drugs that Gilead is developing from nucleotides, the building blocks of deoxyribonucleic acid (DNA), the raw material of genes. GS504 will be tested against cytomegalovirus, or CMV, a virus that frequently attacks AIDS patients, causing inflammation of the retina and eventual blindness. While animal studies suggest kidney toxicity may be a side effect, other drugs have side effects as well. Later this year, Gilead plans to file an investigational new drug application to test a second experimental drug, dubbed GS393, against human immunodeficiency virus (HIV), which causes AIDS. In animal studies, GS393 so far appears more potent than Wellcome PLC's antiviral drug AZT, Dr. Riordan said. The compound also inhibits herpes virus, a frequent companioninfection of AIDS. Dr. Riordan says these first two AIDS-related drugs may be given in convenient oral formulas and also have a long halflife, or active stint in the body, perhaps enabling doctors to give less frequent doses. But he emphasizes there is no guarantee of human safety or effectiveness. "No nucleotide (drug) has ever been in humans yet," he says. The five-year-old company went public in December. Gilead is one of a new wave of biotech companies aiming to use genetic building blocks to fight disease in a different way than most established biotech firms. "Old biotech focuses on the production of beneficial proteins; we're focused on turning off disease-causing proteins," said Dr. Riordan. GS504 is earmarked for Gilead's first time in clinical tests, under its three-part program to treat diseases from viral infections and heart disease to cancer. That program is organized around three kinds of experimental compounds of increasing size: the small molecules for the AIDS virus, medium-sized strands for heart disease, and long strands that would block a gene that triggers cancerous growth. Gilead's cancer work is being done under a pact with Glaxo Inc. The company has $105 million on hand to fund its ambitious research and development program, Dr. Riordan said. Still, given the long lead time and arduous testing required for such experimental drugs, Gilead isn't expecting to see product revenues for "a few years," he said. [This article is made available here by Dow Jones Co. for the personal and non-commercial use of callers to this bbs, in the hope that it will be of some help to those who are suffering from the disease and others who are seeking to help them.]