PRO 140, an innovative new therapy for HIV patients developed by Cytodyn, Inc. (OTCQB: CYDY), is currently undergoing phase 3 clinical trials, having been administered to several patients, according to a company press release (http://nnw.fm/a8eyJ). No other details were provided about the initial results of phase 3 trials, but a separate report said actor Charlie Sheen is one of the subjects and that he has achieved undetectable viral load after taking PRO 140.
Sheen, who revealed his HIV status in November last year, has been a part of the study for eight months and is receiving weekly injections of the drug, the report said. The phase 3 study is looking into PRO 140’s safety and effectiveness in HIV patients and is being administered without any other HIV medication to determine whether it alone is enough to fight HIV and help subjects achieve an undetectable viral load.
Cytodyn, a biotech company that focuses on the development of innovative antibody therapies against the human immunodeficiency virus and other diseases, has not officially commented on the Daily Mail report. In a press release this week, however, it announced that several patients have already been treated with PRO 140 as part of the phase 3, multicenter clinical trial which will enroll a total of 300 subjects. All the patients included in the study have CCR5-tropic HIV-1 infection and are clinically stable, being on highly active antiretroviral therapy up to one week after the enrollment.
During the phase 3 trial, the subjects will receive only PRO 140 in the form of subcutaneous injections for 48 weeks to determine whether the product candidate is safe and efficient as a single-agent maintenance therapy for chronic suppression of HIV. PRO 140 is a fully humanized monoclonal antibody that specifically targets the CCR5 entry receptor on CD4 cells, which HIV targets and takes over. The proprietary therapy fights HIV by blocking this entry point and preventing the virus from infecting healthy cells.
CytoDyn CEO and President Nader Pourhassan, Ph.D. said his company expects the monotherapy trial to yield significant results and provide sufficient data to support further clinical and regulatory advancement of the treatment. He explained that the phase 3 trial is nearly a duplicate of the phase 2b trial that ended last year, with an additional objective of determining why some R5 patients are not responding to the therapy as well as others. Out of 15 subjects who continued the trial in the extension arm and received weekly PRO 140 injections in phase 2b trials, 10 maintained an undetectable viral load for more than two years, while four others did not report any changes in their HIV infection. The last patient moved away and could not be monitored.
Pourhassan is confident that the phase 3 trial findings will help determine which patients can achieve long-term HIV suppression and ultimately secure label expansion for PRO 140 as a single agent therapy, given it has low toxicity and virtually no side effects. PRO 140 only targets HIV patients with the R5 strain, Pourhassan added. This strain currently accounts for about 70 percent of HIV infections and 90 percent of newly-diagnosed cases in the United States.
For more information, visit www.cytodyn.com
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