CytoDyn prepare the bid for a biological FDA license for a pilot drug from HIV
June 9, the pharmaceutical company CytoDyn Inc. announced the first positive results of the effectiveness of promising monoclonal antibody PRO 140, intended for the treatment of HIV infection in combination with other antiretroviral drugs and allowing to prolong the effect of ART. The data was presented at the ASM Microbe 2018 conference in Atlanta.
As the researchers clarify, PRO 140 during a one-week (single dose), randomized, double-blind, placebo-controlled study confirmed compliance with established efficacy points.
"Despite the fact that antiretroviral treatment has advanced much in recent years, new tools of a higher level are needed that will reduce toxicity, prevent drug resistance and improve the quality of life of patients," said Nader Pourhassan, head of CytoDyn.
According to him, the company's results confirm the quality of PRO 140 as simple in the management of long-acting HIV-1 therapy.
The latter, in combination with other ARVs, may be another therapeutic option for patients who have developed resistance to two or more HIV drugs.
The words of Pourhassen confirm the fact: 50 patients with proven HIV-1 replication and confirmed resistance to two or more classes of antiretroviral drugs participated in the clinical study.
The work on the study of the effectiveness of PRO 140 was divided into two stages: in the first part of patients, CI received a single subcutaneous injection of the agent (350 mg), and the second - a placebo. At the second stage, within 24 weeks, all patients were given PRO 140 injections.
The favorable results of the study of the effectiveness of PRO 140, obtained by CytoDyn specialists during the CI, coupled with the data of previous tests, Mr. Pourhassen noted, allowed the developer to start preparing the application for a biological license FDA (BLA).