NetworkNewsBreaks – CytoDyn Inc. (CYDY) Submits IND Application, Protocol for Phase 1b/2 Clinical Trial with PRO 140

November 5, 2018 09:43:16

CytoDyn (OTCQB: CYDY) this morning announced its submission of an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) to carry out a phase 1b/2 clinical trial with PRO 140 as a therapy for metastatic triple-negative breast cancer. Currently, limited therapeutic options are available for triple-negative breast cancer due to an absence of standard biomarkers for targeted options. The original research and issued patents on CCR5 as a therapeutic target for cancer treatment were led by Richard Pestell, M.D., Ph.D., CytoDyn’s Interim Chief Medical Officer. Dr. Pestell’s published conclusions verified that CCR5 is a crucial receptor in the growth, invasion and metastasis of human cancers. PRO 140, a CCR5 antagonist, has recently demonstrated obstruction of human breast cancer cell invasion and colon cancer tumor growth.

“We are honored to have Dr. Pestell lead this effort by overseeing the advancement of PRO 140 in this indication and other planned oncology and autoimmune disease studies,” Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer stated in the news release. “If the early analysis of the trial will demonstrate positive clinical activity, CytoDyn expects to file for breakthrough therapy designation. During the study, a number of correlative studies will be measured to better understand the mode of action of PRO 140, primarily circulating tumor cells (“CTC”). CTC promotes metastasis and metastasis is the leading cause of death of cancer patients. If PRO 140 decreases the CTC by blocking the CCR5 receptor, then we believe PRO 140 may have the potential to disrupt the current standard of care treatments in a variety of cancer indications.”

To view the full press release, visit

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

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