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.
PRO140 works by blocking the HIV co-receptor CCR5 on T-cells, preventing entry of the virus. So far, CytoDyn claims that PRO 140 does not negatively impact the normal immune functions mediated by CCR5.
“A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several weeks of interruption from conventional drug therapy,” according to a news release.”
Read the article on HIV Equal online.