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The Immune Response Corporation Announces Completion of Remune Studies in Italy and Spain; Company Meets Clinical Milestones for 2004
Business Wire - January 11, 2005 10:00
CARLSBAD, Calif., Jan 11, 2005 (BUSINESS WIRE) -- The Immune Response Corporation (Nasdaq:IMNR), a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS), announces that the Company has completed two Phase II clinical trials, one in Italy and one in Spain, investigating its lead HIV immune-based therapeutic REMUNE(R) in HIV-positive subjects.
"With the conclusion of these studies, we are delighted to end the year having met all of our stated REMUNE(R) related milestones," said John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation. "We are currently in the process of auditing and analyzing the data from these two trials. Once finalized, we will submit the data to the FDA as part of ongoing discussions regarding next steps in the REMUNE(R) clinical program. We will also submit for publication in peer-review journals and presentation at scientific conferences."
The trial in Spain, called REMIT, included 39 patients who had previously received REMUNE(R) in an open label study, who were then randomized to receive blinded REMUNE(R) or Incomplete Freud's Adjuvant (IFA) 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(R) 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 (DSMB) reviewed the preliminary unblinded results of the study, and concluded that long-term use of REMUNE(R) posed no safety concerns.
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