Scanning electromicrograph of an HIV-infected T cell. Credit: NIAID.

Cytodyn has reported positive results from a pivotal trial evaluating PRO 140 in combination with anti-retroviral treatment (ART) to treat heavily treatment-experienced HIV-1 infected patients.

The one-week, single-dose, randomised, double-blind, placebo-controlled portion of the two-part pivotal trial has met the primary efficacy endpoint of reducing the patients’ HIV-1 RNA viral load from baseline at the end of the one-week treatment period.

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A total of 50 patients who have demonstrated evidence of HIV-1 replication on existing ART and showed resistance to two or more anti-retroviral drug classes have taken part in the trial.

During the first one-week portion of the trial, patients were randomised into two arms, both of which received ART, while one of the arms received a single dose of 350mg of PRO 140 subcutaneous injection, and the second arm received placebo.

“New agents are needed to improve the potency and pharmacokinetic profiles, decrease toxicity, combat drug resistance, and improve convenience to facilitate patient compliance.”

In part two of the trial, all patients received PRO 140 subcutaneous injections with optimised background ART in an open-label setting for a period of 24 weeks.

CytoDyn president and CEO Nader Pourhassan said: “While ART has greatly advanced over the years, new agents are needed to improve the potency and pharmacokinetic profiles, decrease toxicity, combat drug resistance, and improve convenience to facilitate patient compliance.

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“These trial results support the continued development of PRO 140 as a simple-to-administer, long-acting HIV-1 therapy that, combined with ART, can provide a valuable new therapeutic option for patients who have become resistant to two or more antiretroviral agents.”

PRO 140 is a new class of HIV/AIDS therapeutics and viral-entry inhibitors, which aims to protect healthy cells from viral infection.