Biotechnology company CytoDyn (OTCQB: CYDY) this morning announced the featured interview of its President and CEO Nader Z. Pourhassan, Ph.D. with Stock Day’s Everett Jolly. Jolly initiated the discussion by asking about CytoDyn’s PRO 140. The company’s flagship product is a humanized IgG4 monoclonal antibody that is designed to bind to cellular receptor CCR5, which plays various roles with implications in HIV, tumor metastasis and immune signaling. Pending FDA approval, which the company hopes to secure in Q4 2019, Pourhassan indicates that PRO 140 may be available to the public in 2020. “Most biotech companies, when they finish the biologic application, they have an 85% chance to get approved. 9 out of 10 who don’t get approved is because of the safety of the product. Our product has received fast track designation due to having great safety among all of the approved drugs,” Nader Z. Pourhassan, Ph.D., president and CEO of CytoDyn, stated in the news release.
To hear the Stock Day Podcast featuring the interview, visit http://nnw.fm/kYJU8
To view the full press release, visit http://nnw.fm/4Q7xo
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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