Biotechnology company CytoDyn (OTCQB: CYDY) this morning announced that it will be presenting at the Biotech Showcase at the Hilton San Francisco Union Square in San Francisco, California on January 9, 2019 at 10:30 AM PT. An update on the company’s clinical development programs and objectives for leronlimab (PRO 140) will be co-presented by president and CEO Nader Pourhassan, Ph.D. and chief medical officer and vice chairman Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P. The presentation will provide insights regarding the company’s plans for 2019, including details on its first BLA submission of PRO 140 anticipated to occur during the first half of 2019. Management will also discuss potential licensing opportunities for PRO 140 in China, France, Japan and the United States and will hold a Q&A segment following the presentation. A live webcast and replay of the presentation will be available on the investors section of the company’s website at http://ir.cytodyn.com for 90 days.
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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 half 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 initiated a clinical trial with leronlimab in metastatic triple-negative breast cancer in 2018. For more information, visit the company’s website at www.CytoDyn.com.
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