Biotechnology company CytoDyn (OTCQB: CYDY) today announced that data from its ongoing investigative trial of PRO 140 (leronlimab) as a single subcutaneous therapy in HIV-1 infected patients was accepted for a poster presentation at next year’s Conference on Retroviruses and Opportunistic Infections (“CROI”). Vice President, Clinical Operations at Amarex Clinical Research Dr. Kush Dhody will present the abstract, “PRO 140 SC: Long-acting, Single-agent Maintenance Therapy for HIV-1 Infection,” at CROI 2019, to be held in Seattle March 4-7, 2019.
“We are highly encouraged by the recently reported data from our monotherapy trial for patients receiving once-weekly injections of PRO 140 700 mg,” CytoDyn President and CEO Nader Pourhassan, Ph.D., stated in the news release. “As previously announced, we plan to file a pivotal phase 3 protocol for PRO 140 as a monotherapy for HIV-infected patients before the end of this year. We are excited to share the most recent data from this important clinical trial at CROI, which each year attracts many of world’s leading clinicians in HIV research.”
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CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on PRO 140 (leronlimab), 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 PRO 140 in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. The Company plans to seek FDA approval for PRO 140 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 PRO 140 as a once-weekly monotherapy for HIV-infected patients, and plans to initiate a registration-directed study of PRO 140 monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that PRO 140 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 PRO 140 monotherapy can prevent viral escape in HIV-infected patients, with some patients on PRO 140 monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate PRO 140 for the prevention of GvHD and expects to initiate clinical trials with PRO 140 in metastatic triple-negative breast cancer in 2018. For more information, visit the company’s website at www.CytoDyn.com
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