Biotechnology company CytoDyn Inc. (OTCQB: CYDY) this morning announced its completion of the previously detailed acquisition of privately held ProstaGene, LLC. Per the update, Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P., founder and former chief executive officer of ProstaGene, has been appointed to the CytoDyn board of directors and named chief medical officer with responsibility for leading all PRO 140 (leronlimab) programs in non-HIV indications. “Richard is a driving force in CCR5 antagonist research and we gain significant expertise and intellectual property with this acquisition that advances the development of PRO 140 as a novel cancer metastasis therapeutic,” Anthony D. Caracciolo, chairman of CytoDyn, stated in the news release. “We are privileged to have Richard join CytoDyn to expand our executive and scientific team, and we enthusiastically welcome him as the newest member of our board of directors.” Under the terms of the definitive agreement dated November 16, 2018, CytoDyn acquired substantially all of the assets of ProstaGene, including the transfer or assignment of certain intellectual property rights held by ProstaGene and Pestell.
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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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