Biotechnology company CytoDyn (OTCQB: CYDY) today announced that its board of directors has appointed Scott A. Kelly, M.D., FAAPMR as its chairman. Dr. Kelly has served on CytoDyn’s board since April 2017, and he succeeds Anthony D. Caracciolo, who will continue to serve as a company director. “We are delighted to have Scott serve as our chairman of the board and look forward to supporting him in his new role,” CytoDyn President, CEO and Director of Nader Pourhassan stated in the news release. “Scott has been instrumental in our strategy to aggressively develop leronlimab (“PRO 140”) in certain immunology and oncology indications. He played a key role in our recent acquisition of ProstaGene, which provided CytoDyn with essential patents as well as insight into the role of CCR5 in metastatic cancer. He also was instrumental in our selection of metastatic triple-negative breast cancer as our first oncology indication. Under CytoDyn’s expanded development strategy, we are preparing to enroll breast cancer patients in our first oncology trial while in parallel advancing our clinical programs in HIV.”
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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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