CytoDyn Announces Positive Results from Completed Pivotal PRO 140 HIV Combination Trial

CytoDyn (OTCQB:CYDY) has announced that roughly 81 percent of patients that completed the 25-week CD02 pivotal trial with PRO 140 in combination with existing highly active antiretroviral therapy showed viral load suppression with plasma HIV-1 RNA viral load of less than 50 copies/ML.

As quoted in the press release:

Patients in the multicenter clinical trial were prequalified with CCR5-tropic HIV-1 infection and documented genotypic or phenotypic resistance to HAART drugs within three drug classes or within two or more drug classes with limited treatment options.

“These results show suppression rates with PRO 140 that are very impressive,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn.  “A small molecule CCR5 antagonist approved for a multidrug class resistance population has shown a viral suppression rate of 48% after 48 weeks, and the latest antibody therapeutic approved for a multidrug class resistance population achieved a 43% viral suppression rate after 24 weeks.

“These results support our strategy to pursue the first approval for PRO 140 as a combination therapy for HIV,” he added.  “As previously announced, we plan to submit our Biologics License Application, or BLA, to the U.S. Food and Drug Administration (FDA) on a rolling basis with the first submission as soon as the end of this year.”

Of the 52 patients enrolled in the pivotal trial, 47 completed the 25-week trial period.  Of these, 40 patients requested to continue receiving PRO 140 weekly injections through participation in an extension study.  Several of these patients have maintained viral load suppression with PRO 140 for more than two years.  During the 25-week trial period, no patients experienced serious adverse events (SAEs) related to PRO 140.

Click here to read the full press release.