THE IMMUNE RESPONSE COMPLETES REMUNE STUDIES IN ITALY AND SPAIN

The Immune Response has completed two Phase II clinical trials, one in Italy and one in Spain, investigating its lead HIV immune-based therapeutic Remune in HIV-positive subjects.

The trial in Spain, called REMIT, included 39 patients who had previously received Remune in an open-label study, who were then randomized to receive blinded Remune or Incomplete Freud's Adjuvant during REMIT, and a comparative control group of 19 subjects. This trial was designed as an exploratory Phase II trial with multiple endpoints to give the company more information on the potential role of Remune during antiretroviral treatment interruption. All patients interrupted their antiretroviral therapy regimens, and were followed for 48 weeks. Endpoints included time to virologic rebound and time to re-initiate antiretroviral therapy. An independent data safety monitoring board reviewed the preliminary unblinded results of the study, and concluded that long-term use of Remune posed no safety concerns.

Study IR101-215, a multicenter, randomized study, conducted in Italy, investigated 51 antiretroviral-naïve patients over 28 weeks following treatment with Remune, IFA or saline. Preliminary analysis of the final data suggest that Remune can induce HIV-specific T cells that are believed to be important in the control of HIV, and may also stabilize total CD4+ T-cell counts. These results confirm preliminary data that were presented last year. A rollover study to IR103, which combines Remune with Amplivax, an immunostimulatory oligonucleotide adjuvant, is planned.

Remune is in Phase II development by The Immune Response and is not approved by any regulatory agencies in any country at this time.