BREAKING: An Injectable HIV Treatment Could Be Ready By 2017
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.”
“While the standard of care for HIV infection has been the combination of medications from different antiretroval (ART) classes that interfere with different steps of the viral lifecycle, there is now a significant number of long-term survivors who are facing issues of drug resistance and are in need of new treatment options (Pennings 2013, Cossarini et al. 2013). The company believes this request for Breakthrough Therapy Designation addresses the unmet need for novel therapies for the growing number of heavily treatment-experienced HIV patients, who face a dwindling pool of effective therapeutic options in the face of uncontrolled viral load CD4+ T-cell counts.”
In one study, stable subjects were shifted from daily ART regiment to PRO 140 monotherapy for up to 12 weeks, according to the news release. “Those subjects who were able to maintain viral suppression were allowed to continue PRO140 monotherapy for an additional 60 weeks under extension study.
“Altogether, the three clinical studies demonstrate the proof of concept that PRO 140 monotherapy can reduce the viral load in HIV-1 injected, treatment-experienced patients,’ the CytoDyn news release states. “Once the viral load is undetectable, weekly administration of PRO 140 can help maintain the lower viral load in about 50 percent of patients over an extended period of time (currently shown to be over one year). Based on these preliminary results, the company believes this treatment option addresses the unmet medical need for therapy options for HIV-1 infected patients with uncontrolled viral load, despite conventional ART. The patients who do not benefit from continuing ART could potentially benefit from PRO 140 therapy.”
According to Dr. Nader Pourhassan, CytoDyn’s President and CEO: “Our monotherapy trial and its extension arm, along with prior studies of PRO 140 in HIV patients with detectable and none detectable viral load demonstrates that PRO 140 can reduce the viral load by as much as 1.6 log in three weeks. Once the viral load is undetectable, PRO 140 can keep the viral load suppressed, as evidenced in our ongoing extension study. It will accelerate the process of bringing PRO 140 as a treatment option for patients who have no other alternatives.”
It is important to note that these trials do not include large numbers of people. Also, these press releases contain “forward-looking statements,” meaning, “These statements and information represent CytoDyn’s intentions, plans, expectations, and beliefs and are subject to risks, uncertainties and other factors, many beyond CytoDyn’s control. These factors could cause actual results to differ materially from such forward-looking statements or information. The words “believe,” “estimate,” “expect,” “intend,” “attempt,” “anticipate,” “foresee,” “plan,” and similar expressions and variations thereof identify certain of such forward-looking statements or forward-looking information, which speak only as of the date on which they are made.
CytoDyn disclaims any intention or obligation to publicly update or revise any forward-looking statements or forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable law. Readers are cautioned not to place undue reliance on these forward-looking statements or forward-looking information.”