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Phase 2 Data Indicate That HIV-1 Immunogen Induces HIV-Specific Immunity
CARLSBAD, Calif., Sept. 14 /PRNewswire-FirstCall/ -- An investigational treatment, REMUNE® (HIV-1 Immunogen), induces HIV-specific immunity in drug-naive patients according to interim results from an ongoing multi-center Phase II study conducted in Italy and presented by Renato Maserati, MD, at the Immunomodulating Drugs for the Treatment of HIV conference in Lake Garda, Italy. REMUNE® is being developed by The Immune Response Corporation , a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis.
"Although the Italian study is ongoing, these interim data show REMUNE® induces an HIV-specific immune response in antiretroviral naive subjects and, therefore, the hope that enhanced immunity may delay disease progression," said John N. Bonfiglio, Ph.D., Chief Executive Officer of The Immune Response Corporation. "With guidelines recommending delayed intervention for newly diagnosed HIV patients based on CD4 and viral load counts, an immune-based therapy like REMUNE® that could possibly delay initiation of antiretroviral therapy (ART) would be an important advance in the treatment of HIV. So far the results are tracking with our expectations based upon our knowledge of the therapy. We expect these data to be pivotal in our choice of design for registration trials."
The interim analysis showed that subjects receiving three injections of REMUNE® had a significantly higher level of HIV-specific CD4-positive and CD8-positive memory T cells than control subjects receiving Incomplete Freund's Adjuvant (IFA) or saline, suggesting that REMUNE® can induce the type of immune responses that could be clinically important. There were no significant changes in CD4 cell count or viral load in any of the study groups through week 12 as was expected due to the length and design of the trial.
"We were impressed with REMUNE®'s effect on HIV-specific immune responses in drug-naive subjects seen in this study," said Georgia Theofan, PhD, Vice President of Clinical Development at The Immune Response Corporation. "We are looking forward to the final analysis from this study at the end of the year. We also plan to rollover these subjects into a trial with IR103 designed to be completed next year."
The multi-center, single-blind, randomized study investigated 50 subjects over 28 weeks following treatment with REMUNE®, IFA or saline. The study had two patient groups treated with either one or three injections of REMUNE® and each of the other arms received three injections of either IFA or saline. The four arms of the study each received injections at weeks 0, 12 and 24; with all subjects completed through week 12 and a subset of 30 subjects completed through week 28. 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 Corporation and is not approved by any regulatory agencies in any country at this time. Dr. Maserati has served as a clinical investigator to The Immune Response Corporation and has received research funding support from the company.
Amplivax™ was developed by Hybridon, Inc. and has been licensed to The Immune Response Corporation.
Source: The Immune Response Corporation