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CytoDyn says leronlimab prevents transmission of simian HIV in pre-clinical study on macaques

The study tested the impact of a macaque-equivalent leronlimab dose of 350 mg weekly or 700 mg bi-monthly in 18 monkeys with Simian-Human Immunodeficiency Virus

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Leronlimab works by blocking CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases

CytoDyn Inc (OTCQB:CYDY) announced Tuesday that its potential HIV pre-exposure prophylaxis (PrEP) drug leronlimab prevented transmission of the simian equivalent of the disease in a pre-clinical study of macaques. 

The study tested the impact of a macaque-equivalent leronlimab dose of 350 milligrams (mg) weekly or 700 mg bi-monthly in 18 macaques with Simian-Human Immunodeficiency Virus (SHIV). Results showed that the bi-monthly dose completely prevented rectal transmission of the disease.

The study results were revealed at the 23rd International AIDS Conference in a presentation titled, “CCR5 antibody blockade protects rhesus macaques from rectal SHIV acquisition." The drug works by blocking CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases.

“The results reported here in the preclinical macaque model of HIV sexual transmission support leronlimab as a possible PrEP agent at a time when long-acting human HIV PrEP options are limited,” Jonah Sacha, a professor at Oregon Health & Science University and the study’s lead investigator said in a statement.

READ: CytoDyn executes agreement with American Regent for US distribution of Leronlimab as a coronavirus treatment

“We are eager to build upon these preclinical results describing leronlimab’s utility in HIV prevention by initiating clinical studies for leronlimab as a PrEP treatment,” CytoDyn CEO Nader Pourhassan added.

“Current PrEP options require a continued daily dosing regimen in order to be effective and are inherently difficult to maintain in the long-term. Coupled with its safety profile, leronlimab could offer a much needed simple and long-lasting preventative treatment option for people at risk of HIV infection.”

Leronlimab has previously been awarded Fast Track designation by the US Food and Drug Administration (FDA) for its indications as a treatment for metastatic triple-negative breast cancer.

Additionally, the FDA previously granted a so-called rolling review for the drug as part of CytoDyn's biologics license application submission for treatment of the coronavirus (COVID-19). It has been granted more than 60 emergency Investigational New Drug authorizations by the FDA and plans to provide clinical updates for this patient population in the coming weeks.

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

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CytoDyn to submit request for pre-submission meetings in U.K. for Leronlimab

CytoDyn Inc (OTCQB: CYDY) CEO Nader Pourhassan shared news with Steve Darling from Proactive that the company has started the process of requesting meetings in the U.K. for leronlimab as an HIV treatment as well as for emergency approval of leronlimab for COVID-19 patients with mild-to-moderate...

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