CytoDyn Inc. (OTCQB: CYDY), a biotechnology company developing innovative treatments for multiple therapeutic indications, this morning detailed its strategy for completing the development of PCaTest, a novel gene-based prognostic test for prostate cancer developed by ProstaGene. Following the completion of its previously announced proposed acquisition of assets from ProstaGene, which is expected to close during the fourth quarter of 2018, CytoDyn intends to initiate a clinical study aimed at further demonstrating the superiority of the PCaTest, as compared with current genetic tests, in predicting outcomes of individuals with prostate cancer. Per the update, results are expected to be available within four months of the commencement of this clinical study. “Our plan is to complete development of the PCaTest relatively quickly and at a minimal cost to CytoDyn and to file for U.S. Food and Drug Administration (FDA) approval,” Nader Pourhassan, Ph.D., president and CEO of CytoDyn, stated in the news release. “We will gain access to the PCaTest, in addition to the technologies and patents for CCR5 antagonists in metastatic cancer from ProstaGene, with completion of this acquisition expected in the near term.”
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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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