Subject: Immune Response Corp. Expects to Begin Human Trials of HIV Vaccine This Year Date: Published: 7/1/91 (104 lines) Source: Wall Street Journal. Copyright Dow Jones & Co. Inc. Immune Response Corp. Expects to Begin Human Trials of HIV Vaccine This Year ---- By Sonia L. Nazario Staff Reporter of The Wall Street Journal SAN DIEGO -- Immune Response Corp., which is developing a vaccine against human immuno-deficiency virus infection, expects to begin human clinical trials of uninfected individuals by the end of this year, James B. Glavin, president and chief executive officer, said. Mr. Glavin said the company would conduct initial clinical trials of its HIV vaccine on 10 to 15 uninfected patients in California. Among the patients: polio pioneer and Immune Response founder Jonas Salk. "We don't say this vaccine will eliminate the HIV infection. But it does give you something to fight the infection," Mr. Glavin said."We may be able to prevent someone who is HIV-infected from progressing into getting AIDS conditions." Despite advances in the testing of its vaccine, Immune Response expects to report a second-quarter net loss of $900,000, or six cents a share, largely because the company is in the research and development stage of its products, Mr. Glavin said. A year earlier, the company reported net income of $232,759, or two cents a share. Mr. Glavin says the firm expects to report revenue for the quarter just ended of more than $1 million, compared with $1,041,145 a year earlier. Mr. Glavin said that the loss for Immune Response, which is conducting research and development for several vaccines but has no products on the market, was expected. Since last year, the company has been in a joint agreement with Rhone-Poulenc Rorer Inc. to develop, make and market the company's HIV Immunotherapeutic vaccine, which is undergoing human clinical trials in patients infected with the virus. Mr. Glavin said the partners alternate paying for development costs, thus Immune Response's loss for the quarter this year and net income in the previous second quarter. Various other companies are in different stages of testing their own acquired immune deficiency syndrome vaccines. The Immune Response vaccine, the company's first product under development, is based on a scientific approach first suggested by Dr. Salk. He proposed using whole but inactivated AIDS viruses to inoculate people already infected. Where other researchers use genetically engineered or synthetic virus proteins, Dr. Salk has chosen to use live virus killed with gamma radiation. Some scientists have said they believe such viruses to be unsafe in humans, but Immune Response said it safely completed testing of the vaccine on humans infected with the AIDS virus. The uninfected patients to be inoculated this year will be tested for changes in their immune response system. If such a response registers, the company will test the vaccine in a larger population of patients, perhaps in Africa, where there is rapid growth in the AIDS virus. To date, Immune Response's primary research has been on using the vaccine in patients who are already HIV infected. In an initial study of these, the safety of the vaccine was confirmed, Mr. Glavin said. In addition, after more than a year of follow-up, 10 of the 19 showed a gain in their levels of immune cells, with a substantial improvement in their T-cell count, the white blood cells that are normally depleted over time by AIDS. The number responding to skin tests of their immune reactivity jumped to 63% from 20%. The study began in 1987, and Mr. Glavin said that of the 19 HIV-infected patients, 15 have stabilized and remain free of the AIDS virus, three have either developed AIDS or seen their condition worsen, and one has died of the disease. "The numbers are staggeringly in our favor," Mr. Glavin said. "This is remarkable vis-a-vis the results anyone else is getting." The company is now in the third phase of testing the vaccine for efficacy in infected patients and expects to have results in September 1992. Mr. Glavin said he believes it will be the first therapeutic vaccine to come up for Food and Drug Administration approval, probably in 1993. In addition, the company is working on vaccines to treat certain autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and Type I diabetes. It plans to begin human clinical trials this year on patients with rheumatoid arthritis and a year after that on those with multiple sclerosis and Type I diabetes. Mr. Glavin said that although others are working on similar vaccines, he believes Immune Response will be the first to apply for FDA approval. He said the company is also beginning work on a vaccine for tumor therapy. For the six months, Mr. Glavin said, the company expects to report a loss of almost $3 million, or about 24 cents a share, compared with net of $89,868, or one cent a share. Immune Response expects revenue of about $2 million, compared with $2,302,123 last year. The company, which recently completed a secondary offering, has about $54 million cash on hand, Mr. Glavin said, and expects to spend about $8 million this year on research and development. [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.]