Biotechnology company CytoDyn Inc. (OTCQB: CYDY) this morning provided an update on its PRO 140 (leronlimab) as a single agent for maintenance of HIV viral load suppression. Per the update, approximately 92 percent of newly enrolled patients administered PRO 140 in a 700 mg dosage as part of the CD03 Phase 3 investigative monotherapy trial have achieved viral load suppression. Patients enrolled in the Phase 3 monotherapy trial were prescreened for CCR5-tropic HIV-1 infection and treated for up to 12 weeks.
“Our analysis of data indicate that patients treated with PRO 140 700 mg dose who achieve suppressed viral load at the six-week mark are highly likely to continue to maintain suppressed viral load,” CytoDyn president and CEO Nader Pourhassan, Ph.D., stated in the news release. “Given these promising data (92% responder rate), we plan to submit a pivotal monotherapy trial protocol for PRO 140 as a single-agent maintenance therapy before the end of 2018 with the intention of filing for a label expansion subject to combination therapy’s first approval.”
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About CytoDyn
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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