Biotechnology company CytoDyn (OTCQB: CYDY) today announced recent clinical study results showing that its PCaTest provides substantial additive value for predicting outcomes for prostate cancer patients compared to the Gleason score, the current standard for prostate cancer diagnosis. The new findings support CYDY’s strategy for seeking FDA approval for the PCaTest. “Unfortunately, current tests not able to precisely determine whether an individual’s cancer will result in death if not treated aggressively,” CytoDyn Chief Medical Officer and developer of the PCaTest Richard Pestell , M.D., Ph.D., F.A.C.P., M.B.A., stated in the news release. “On the other hand, aggressive treatment for prostate cancer has significant long-term side effects that can include incontinence, erectile dysfunction and dribbling, and should be avoided if possible. The PCaTest uses a proprietary artificial intelligence approach designed to yield a more accurate prognostic result. In essence, we believe the test is designed to identify with greater certainty patients whose lives are at risk if they don’t have their prostate removed. The test is being developed to show gene signatures can help guide patients and their doctors to make better informed decisions about treatment.”
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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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