Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - 18 March 1996
Rhonda L. Rundle, Staff Reporter of The Wall Street Journal
The new study will involve about 2,500 patients at more than 50 U.S. medical centers, one of the largest studies ever undertaken of an experimental AIDS treatment. The test is expected to determine once and for all whether the therapy, called Remune, delays the onset of AIDS in HIV-infected people. The trial is also unusual because it allows participants to continue taking their current medicines, including any of the three new AIDS drugs just approved by the U.S. government.
Remune is a therapeutic vaccine proposed a decade ago by Dr. Salk, a cofounder of Immune Response, who believed that a deactivated version of the AIDS virus might work much like the polio vaccine he developed in the 1950s. "This therapy could provide physicians with an entirely new weapon against HIV that complements the anti-HIV drugs now available," Immune Response said.
Immune Response, based in Carlsbad, Calif., recently stopped calling Remune a "vaccine" because "it confused people" who thought it was designed to prevent AIDS, rather than to slow progression of HIV, said company spokesman Steven L. Basta. Remune's developers are hoping the product prolongs life by boosting the immune system's attack on cells infected by the AIDS virus.
Many researchers think this is a promising approach, but it remains to be seen whether Remune or any other immune system booster will win a role in the growing arsenal of anti-AIDS therapies. Earlier test results of Remune in about 300 patients were inconclusive. Some independent researchers who have reviewed the data say Remune triggers a weak response that isn't powerful enough to have a significant benefit for patients.
"It's quite safe, and I'm in favor of their testing it on their own nickel, but I have my doubts about whether it's likely to work," said Robert Schooley, head of the University of Colorado's infectious disease division in Denver. Dr. Schooley participated in a Food and Drug Administration committee review of Remune in January 1995 that recommended that the company be permitted to proceed into pivotal trials. The test's launch was delayed because of various FDA concerns.
Patient advocates said they were pleased that Remune was finally being put to the test. "Anything that shows it might help should be pushed hard. You can only find out if it works by testing it," said David Scondras, president of Search for a Cure, a Boston-based group. Trial participants will receive a Remune injection every 12 weeks for the duration of the three-year study.
The test's size was dictated in part by the goal of obtaining statistically significant results in groups of patients taking many different combinations of anti-AIDS drugs, said Stephen Lagakos, the trial's senior statistician and a professor of biostatistics at Harvard University. The test is designed to compare the number of patients who progress to AIDS in treatment groups that receive Remune compared with groups receiving similar treatment but not Remune.
Dr. Lagakos said it will take about a year to enroll all the patients, and another two years before all the data are evaluated. The trial could be stopped sooner if an independent committee determines that interim results show a big enough benefit to patients, Dr. Lagakos said. His coleader on the study is James Kahn, associate professor of medicine at the University of California, San Francisco. Both men stressed in separate interviews that they have no financial ties to Immune Response.
Immune Response said it plans to recruit up to 3,000 HIV-infected patients, enough to assure enrollment of 2,500 people after dropouts. The study is expected to cost $30 million over three years, a major chunk of the company's $42 million in current cash. Mr. Basta said Immune Response will finance the trials through a combination of internal resources and future financings. Immune Response said it and a former partner have so far spent a total of $70 million to develop Remune.
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