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NetworkNewsBreaks – CytoDyn Inc. (CYDY) Appoints Chief Technology Officer Nitya G. Ray, Ph.D.

Company: CytoDyn Inc. (CYDY)
Category: News

Biotechnology company CytoDyn (OTCQB: CYDY) today announced that it has named Nitya G. Ray, Ph.D. to serve as its new chief technology officer – head of process sciences, manufacturing & supply chain.  Dr. Ray, from November 2015 to June 2017, served as CytoDyn’s senior vice president of manufacturing.  Most recently, he served Actinium Pharmaceuticals, Inc. as its executive vice-president, head of product development, manufacturing and supply chain. Prior to joining CytoDyn in 2015, Dr. Ray was senior vice president at Progenics Pharmaceuticals, Inc. and, during his 14-year tenure there, was responsible for manufacturing, process and analytical sciences, and quality control. Dr. Ray possesses extensive knowledge of leronlimab (“PRO 140”) development and, at Progenics, successfully manufactured the first 10 batches of leronlimab under GMP, which was approved by the FDA for use in all clinical trials.

“We are pleased to have Dr. Ray return to our company to lead the final preparation of all CMC activities in connection with our upcoming BLA filing and drug supply for product launch,” CytoDyn President and CEO Nader Pourhassan, Ph.D. stated in the news release. “Dr. Ray, with his intimate knowledge of leronlimab (“PRO 140”) CMC development, is uniquely qualified to lead our preparation for the commercial launch of leronlimab in 2020 to meet the expected demand for significant revenue opportunities. CytoDyn is also anticipating to have early interim data for triple negative breast cancer in the first quarter of 2019.  If such results are positive, our need for large quantities of leronlimab may be accelerated.”

To view the full press release, visit http://nnw.fm/F77q3

About CytoDyn

CytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab (PRO 140), 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 leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. The company plans to seek FDA approval for leronlimab 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 leronlimab as a once-weekly monotherapy for HIV-infected patients, and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab 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 leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining virally suppressed for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and expects to initiate clinical trials with leronlimab in metastatic triple-negative breast cancer in 2018. More information is at www.CytoDyn.com.

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