Biotechnology company CytoDyn Inc. (OTCQB: CYDY) today announced that the United States Adopted Names (“USAN”) Council has designated leronlimab as the official name for its PRO 140. The investigational new drug has not yet been approved for any indication; however, CytoDyn is exploring partnering and licensing agreements for HIV treatment with intention to pursue use of leronlimab in cancer and other autoimmune diseases. “As we recently announced, we are very pleased with the results of our monotherapy higher dose of leronlimab 700 mg showing an impressive responder’s rate of over 90%,” CytoDyn President and Chief Executive Officer Dr. Nader Pourhassan stated in the news release. “We have two HIV populations that we are hopeful to have final approval for treating with leronlimab in 2019 (combination therapy) and 2020 (monotherapy). Additionally, our leronlimab cancer study could have a read out by the first quarter of 2019 through the use of a circulating tumor cell (“CTC”) measurement, which can be done with a simple blood test.”
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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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