The Immune Response Presents Encouraging Results for Remune

The Immune Response has presented results from a Phase II clinical trial with Remune, the company's lead HIV immune-based therapy.

The study (IR101-215), conducted at four sites in Italy, was designed to explore the potential utility of Remune and ongoing analysis will explore immunological information. The data demonstrated stabilization of CD4+ cell counts, which is believed to indicate immune responses against HIV disease in antiretroviral-naive patients treated with Remune. The analysis included data from all 49 patients who completed the study, and showed that median absolute CD4+ cell counts remained stable through Week 28 in the patients that received three injections of Remune, but declined in both the IFA and saline groups.

The multicenter, single-blind, randomized study followed 51 patients over 28 weeks following treatment with Remune, IFA or saline. Although minor adverse events were reported, no treatment-limiting toxicities have been recorded to date. This trial was intended to explore the potential utility of Remune and was not designed to have enough statistical power to be used for regulatory approval. The company is planning a clinical program that would use the data from this and other trials to design registration trials in the near future. Remune is in Phase II clinical development by The Immune Response and is not approved by any regulatory agencies in any country at this time.