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Immune Response to expand phase 2 trial for investigative HIV immunotherapy IR103
By Elaine Rigoli
Tampa, Fla., June 19 - The Immune Response Corp. has obtained approval to expand its phase 2 HIV clinical study to include an additional 50 patients.
The company said it plans to enroll more than 200 drug-naive patients in two parallel studies with sites in Italy, France, Canada and the United Kingdom.
The company said the study, which has enrolled 31 returning patients from a previous trial and 54 new patients, will examine IR103, a second generation immunotherapy, as a first-line treatment for drug-naive HIV-infected individuals not yet recommended for antiretroviral therapy according to current medical guidelines.
The study is designed to assess the safety and ability of various doses of IR103 to induce HIV-specific immunity, according to a news release.
The trial will also measure changes in CD4+ counts, a critical marker of HIV disease progression that is used, along with viral load, to determine when a patient should begin antiretroviral therapy, the release said.
Based in Carlsbad, Calif., Immune Response is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases.
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