Subject: Imreg Touts an Immune-System Booster As AIDS Treatment Date: Published: 2/9/87 114 lines Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Imreg Touts an Immune-System Booster As AIDS Treatment; Skepticism Abounds --- By Dianna Solis Staff Reporter of The Wall Street Journal From an unlikely backwater of the scientific world, tiny Imreg Inc. is betting it will produce one of the first commercial treatments for acquired immune deficiency syndrome. The six-year-old New Orleans-based biotechnology concern today places itself on the "cutting edge" of immunology based on its drug's potential applicability in the treatment of AIDS and of other diseases. But in the AIDS research field, which abounds with skepticism, Imreg is receiving a full dose as it plunges into final testing of a drug to boost the AIDS-virus carrier's ability to fight the disease by strengthening the immune system. Many other experimental drugs focus on combating the complex AIDS virus itself. The skepticism has several causes. Imreg has refused to release the chemical composition of its so-called immunoregulator, Imreg-1, as many of its rivals in the high-stakes rush to market have done. In addition, researchers privately have questioned some of the methodology and preliminary results of the company's early clinical trials. On top of everything else, Imreg, which went public three years ago, lately has been the target of persistent, large-scale short-selling on the national over-the-counter market. In a short sale, an investor borrows stock and sells it, hoping to buy it back later at a lower price. As of the end of January, 7.9% of the company's stock was sold short, and the National Association of Securities Dealers has begun an investigation. But to A. Arthur Gottlieb, a former Harvard Medical School professor and Imreg's president and chief executive officer, criticism and outright disbelief simply go with the job of trying to commercialize an answer to an extraordinary public-health problem. "I think it is fair criticism," Dr. Gottlieb says. But he adds, "We are very excited about what we know, and we think there is going to be substantial interest in it when it is disclosed." Imreg says it has withheld details of the drug's composition because patent applications on Imreg-1 derivatives are still pending here and abroad. And the company insists it will divulge its final test results only at scientific meetings or in medical journals, in keeping with medical protocol. Nevertheless, Imreg has made a few fans in the investment community. As David Garcia, an analyst with Howard, Weil, Labouisse & Friedrichs, a New Orleansbased brokerage that makes a market in the stock, said, "There is more than a passing possibility that we are witnessing one of those once-in-the-decade breakthroughs." A larger number of investment advisers that follow Imreg base their advice, in part, on AIDS researchers' conviction that anti-viral treatments should be the primary means of attacking the disease. One, Michael Connor of Balfour Securities, New York, explained, "we feel ... the drug hasn't progressed far enough in testing to have any sense of confidence yet." On Friday, Imreg reported that its fourth-quarter net loss widened to $728,906 from $415,333 a year earlier. For the full year, Imreg posted a loss of $2.1 million, compared with a loss of $1.3 million in 1985. Imreg has spent about $5 million over the past six years to develop its drug. AIDS researchers generally agree that a double-fisted approach is needed to fight AIDS: one drug to combat the AIDS virus and a second, such as Imreg-1, to repair the ravaged immune system. Imreg describes its drug as a naturally occuring substance derived from human white blood cells. It is believed to enhance the function of T-4 helper cells, which initiate and regulate most immune-system functions. The company said results from its earlier clinical trials in which participants were given injections of antigens, or irritating foreign substances, indicate that Imreg-1 had restored an immune response in 15 of 29 cases. Imreg has begun phase-3 trials for efficacy, using 150 patients diagnosed as having AIDS or a pre-AIDS condition called AIDS-related complex, or ARC. The so-called double-blind tests, in which onethird of participants are injected with a placebo, are expected to conclude by year's end. Dr. Gottlieb says the company plans to apply for marketing approval from the Food and Drug Administration as soon as analysis of the data is complete and that "appropriate discussions" with pharmaceutical companies have begun. Despite the preliminary results, many researchers remain lukewarm, noting that, among other things, Imreg didn't use a placebo-control group in phase-2 testing. Dr. Gottlieb responds that researchers told him it would be difficult to obtain AIDS-virus carriers who would be willing to participate in trials involving placebo injections. He also noted that placebo-control groups aren't always used in earlier, phase-2, tests. Also, institutions involved in current testing of Imreg-1 express optimism. "I think the preliminary data from Imreg justifies the third test," says Dr. Michael Lederman, an immunologist at University Hospitals of Cleveland. He cites positive results with a related substance in his previous AIDS research, which is described in the current Journal of the American Medical Association. (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.)