Subject: Who's News: Moving to the Fore in AIDS Research Date: Published: 8/19/87 127 lines Source: WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. Who's News: Moving to the Fore in AIDS Research --- By Marilyn Chase Staff Reporter of The Wall Street Journal Franklin Volvovitz -- "that's mister, not doctor," he notes -- recalls getting hooked on immunology at Conard High School in West Hartford, Conn. Today, with one defunct biotechnology company behind him, the 38-year-old Mr. Volvovitz heads another concern, MicroGeneSys Inc., that suddenly is riding the crest of the wave of publicity in researching acquired immune deficiency syndrome. Forging ahead of big, established competitors, MicroGeneSys (pronounced "micro-genesis") developed an experimental AIDS vaccine and received federal approval to begin the first U. S. testing of such a vaccine on humans. While the industrial leaders in AIDS research profess to know little of Mr. Volvovitz or his tiny 30-employee company, federal health officials obviously were sufficiently impressed. The forthcoming tests will team up Mr. Volvovitz, a young corporate tyro, with a seasoned federal AIDS administrator in one of the most technically difficult challenges in modern infectious disease history. The federal official, Anthony S. Fauci, the 46-year-old director of the National Institute of Allergy and Infectious Diseases, says that Mr. Volvovitz and his company face a tough evaluation. Dr. Fauci's institute is the unit of the National Institutes of Health that oversees much of the country's AIDS drug -- and now vaccine -- testing. Although test animals showed no immune suppression in the tests of MicroGeneSys's vaccine, Dr. Fauci says, "These are the questions we'll ask: Is it toxic, and is it immunogenic? " -- that is, inducing antibodies and other cellular immune responses. Dr. Fauci emphasizes that the approval for MicroGeneSys's tests doesn't imply any sort of endorsement. Approval came, he says, as a result of the company's timely Food and Drug Administration filing, coupled with good animal test data. Some observers have suggested other big companies may intentionally have hung back to let a small biotech boutique take the risks of a high-profile initial vaccine trial. Dr. Fauci doesn't expect that reluctance to last for long. "There are many companies in various stages (of FDA application)," Dr. Fauci says, "So I wouldn't be surprised if other vaccines started coming along. We've made the offer to any group who would like to use our vaccine-testing facilities." Mr. Volvovitz, MircoGeneSys's chairman and president, acknowledges that the AIDS vaccine test will be his company's first clinical trial. The plainspoken Mr. Volvovitz says his high school fascination with immunology grew when he was a graduate student at New York University, where he won an in-house grant to study the effects of different interferons on the body's immune system. But he left the university's doctoral program in 1979 to found his first company, BioTechnologies Inc., focusing on interferons. It was a short-lived endeavor. "After about a year of operations, the investors simply liquidated the company," he says. He took two years to size up other biotechnology opportunities, and in 1983 founded MicroGeneSys in West Haven, Conn., to develop recombinant vaccines. This time he became the principal shareholder of the closely held company. He won't identify other investors in the company, or elaborate on where the funding for its AIDS initiative came from. He will say that AIDS is one of eight vaccines in the MicroGeneSys pipeline. He concedes that one of its other products, such as its malaria vaccine, probably will beat the AIDS vaccine to market. But while the company is a relative newcomer to AIDS, it has been trying to position itself as a front-runner in that field. "In 1985, we began a serious effort in the AIDS area," Mr. Volvovitz says. "We felt we had an applicable technology . . . and felt a responsibility as good citizens" to devote some of the company's energies to the disease that now has struck about 40,000 Americans and killed more than half of those infected. "By the end of 1986, we set a goal to become one of the first" companies in the AIDS vaccine area, Mr. Volvovitz says. That is an ambitious agenda, considering the long roster of other contenders, including Genentech Inc., Chiron Inc. in collaboration with Ciba-Geigy Corp., Repligen Corp. with Merck & Co., and Cambridge Bioscience Corp. with Institut Merieux of France. Despite MicroGeneSys's youth and inexperience, animal tests of the VaxSyn vaccine in rhesus monkeys and chimpanzees provoked levels of antibodies that were "quite impressive . . . quite high," Dr. Fauci says. Nevertheless, he says the first phase of VaxSyn test, which will use 63 men, mostly homosexuals, in the Washington, D. C., area, will focus exclusively on safety of the product -- not its effectiveness. Federal officials estimate the AIDS virus now infects 1.5 million Americans. Because of the epidemic's advance and the uncertainty about how to prevent further infection, the vaccine trial will be surrounded with an aura of urgency and pressure -- even though Dr. Fauci doesn't expect answers until the mid-1990s. Dr. Fauci is used to such pressure. In his role as overseer of federal AIDS drug testing, he has been prodded and recently subjected to personal attacks by groups angry about the pace of federal research. "I try to keep a sense of calm and equanimity (rather than) smoke and steam about it," he says. "It doesn't affect my work." Meanwhile, the aura of mystery surrounding MicroGeneSys and its principals isn't being dispelled by Mr. Volvovitz, who is tight-lipped about identities of the company's backers and academic collaborators. In the world of big-league vaccine developers, they weren't a household word, despite having delivered a paper at the Third International Conference on AIDS in June. Paul Luciw, a vaccine researcher at the University of California at Davis who collaborates with polio-vaccine pioneer Jonas Salk of the Salk Institute, says: "The list of major contenders is well-known. And these guys are new." [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.]