CytoDyn Inc. announced in a news release last week that its ongoing extension study of PRO 140 monotherapy has shown “complete viral-load suppression” for well over a year, with some patients approaching 17 months. The phase I trial included 23 patients.
“The company believes that complete virologic suppression through treatment with a single agent, PRO 140, a safe and efficacious antibody, rather than through the widely used HAART combination therapy, could present a significant opportunity to treat HIV patients. Based on these monotherapy results, the company plans to file a second Phase 3 protocol for PRO 140 monotherapy with the FDA. CytoDyn is currently conducting a pivotal phase 3 trial for PRO 140 as an adjunct therapy with expected commercialization in 2017.”
On Jan 22, the company filed a request for Breakthrough Therapy Designation with the FDA for PRO 140 as a treatment for HIV-1 infection in treatment experienced patients with virologic failure, meaning other medications alone no longer work for them.
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