By Mary Welch
HIV-infected patients treated with Remune and HAART, a highly active antiretroviral therapy, showed significantly improved immunologic markers compared to patients who took HAART with placebo. The results of the 32-week, multicenter Phase II trial involving 43 patients were released by The Immune Response Corp., of Carlsbad, Calif., which along with Agouron Pharmaceuticals Inc., of La Jolla, Calif., is developing Remune.
Remune is inactivated HIV combined with a mineral-oil-based adjuvant and is designed to stimulate a patient's own immune defenses.
The study also showed positive trends in virologic markers for disease progression compared to the HAART plus placebo group.
"The results at 32 weeks are similar to the interim results at 20 weeks," said Charles Cashion, senior vice president of Immune Response. In the trial, 43 persons received HAART for four weeks. After that, half of the participating 43 persons received Remune with HAART; the others, HAART and a placebo. After 32 weeks, the group receiving HAART and Remune had significantly higher lymphocyte proliferative responses. The placebo-receiving group did not develop significantly higher lymphocyte proliferative responses.
"The data suggests that Remune may significantly enhance an HIV-1 specific immune response to the strain of virus most commonly found in the U.S.," Cashion said.
The Remune group also showed significant increases in production of MIP-1 beta, a beta-chemokine associated with viral load suppression and skin test reactivity in HIV antigens.
"We believe that Remune may stimulate the immune system against the virus and may also stimulate specific antiviral substances, such as chemokines, which are produced by the immune system and may naturally protect T cells from HIV infection," Cashion said. "We were also encouraged that, although they were not statistically significant, that there appears to be encouraging results in the viral markers on HIV RNA." That theory will be tested in a Phase III Remune-HAART study of 300 HIV patients that will be conducted by Agouron and will test specifically for the HIV RNA markers.
Phase III trials, conducted by Immune Response, began in 1996, with the endpoints being disease progression to AIDS or death, Cashion said. Some 2,500 patients at 74 sites are participating. The trial is slated for completion by next spring.
In June, Immune Response signed a $77 million pact with Agouron to develop and commercialize Remune over the next two years. The companies intend to file a marketing application with the FDA by the fourth quarter of 1999. (See BioWorld Today, June 12, 1998, p. 1.)
Immune Response's stock (NASDAQ:IMNR) closed Monday at $12.437, down $0.125. *