US-based biotechnology firm CytoDyn has dosed the first patients in its Phase IIb clinical trial, a treatment substitution protocol for patients with human immunodeficiency virus (HIV), with its lead product candidate, PRO140.
The trial’s primary objective is to evaluate the efficacy of PRO 140 monotherapy for the maintenance of viral suppression in HIV patients who are stable on combination antiretroviral therapy, known as HAART (highly active antiretroviral therapy), but need or wish to discontinue HAART therapy temporarily.
The company said that new therapeutic regimen will potentially allow HIV patients to take a ‘drug holiday’ from their HAART with weekly injections of PRO 140.
If the Phase IIb trial is successful, the company intends to evaluate twice-a-month and once-a-month self-injection therapy.
CytoDyn president and chief executive officer Nader Pourhassan said PRO 140 has the potential to change the treatment paradigm for patients with HIV/AIDS.
"We are very encouraged based on results from previous clinical trials that this study will provide a new therapeutic alternative," Pourhassan said.
"The formal initiation of this clinical trial marks a major step forward in the advancement of our lead product candidate.
"For the first time, the company is sponsoring this clinical trial itself. In the past six months, PRO 140 has obtained a green light from the FDA for two Phase 2b clinical trials, which we expect to ultimately deliver treatment alternatives for patients and value for our shareholders."
PRO 140 belongs to a new class of HIV/AIDS therapeutics which are intended to protect healthy cells from viral infection.
The company said that PRO 140 is a humanised monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.
The monoclonal antibody has been the subject of four Phase I/Ib and two Phase IIa clinical trials, each showed its ability to reduce HIV viral load in human test subjects, and has also been awarded fast-track status by the FDA.
Image: CytoDyn intends to develop PRO 140 as a therapeutic anti-viral agent. Photo: courtesy of freedigitalphotos.net.