CytoDyn (OTCQB: CYDY), a biotechnology company, is focused on providing a treatment to the millions of people infected with the human immunodeficiency virus (HIV). A recent article discussing the company reads, “HIV targets the immune system and weakens the body’s defense systems against infections and some types of cancer. During 2017, some 1.8 million people became newly infected with HIV, bringing the global total to 36.9 million people living with HIV, according to the World Health Organization (http://nnw.fm/043wY). HIV continues to be a major public health issue, having claimed more than 35 million lives so far from every corner of the world. The market potential for PRO 140 used as an anti-viral agent in combination with a patient’s current HIV regimen (Highly Active Antiretroviral Therapy, or “HAART”) is $1.2 billion; as a monotherapy maintenance/single-drug therapy, the market is estimated at $3.8 billion.”
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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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