QualityStocksNewsBreaks – CytoDyn Inc. (CYDY) Foresees Market Availability of PRO 140 by 2020

Biotechnology company CytoDyn (OTCQB: CYDY) anticipates that it will attain final FDA approval for its HIV treatment, PRO 140, by the fourth quarter of 2019. The company expects market availability will follow by 2020. An article further discussing the company reads, “Leronlimab (PRO 140) is part of a new class of HIV drugs that protects healthy cells from infection by the virus. It’s a humanized IgG4 monoclonal antibody that binds to CCR5, a cellular co-receptor with multiple roles including implications for HIV infection, tumor metastasis and immune signaling. Less frequent dosing, minimal side effects and hardly any toxicity are among multiple potential benefits that distinguish PRO 140 from HIV treatments in current use.”

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About CytoDyn

CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab (PRO 140), a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 plays a key role in the ability of HIV to enter and infect healthy T-cells.  The CCR5 receptor is also implicated in tumor metastasis and in immune-mediated illnesses such as graft-vs-host disease (GvHD) and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. The company plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biological License Application (BLA) in the first quarter of 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients, and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and expects to initiate clinical trials with leronlimab in metastatic triple-negative breast cancer in 2018. More information is at www.CytoDyn.com.

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