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CytoDyn Inc. (CYDY) to Complete Development of Prostate Cancer Prognostic Test Following Close of ProstaGene Acquisition

  • PCaTest has already proven a superior predictive ability in comparison with other genetic prognostic tests
  • Cytodyn in the process of acquiring PCaTest developer ProstaGene and will launch a clinical study once the transaction is complete
  • Prostate cancer is the second-most common type of cancer among American men, with almost 165,000 new cases expected this year

Biotechnology company CytoDyn Inc. (OTCQB: CYDY) has unveiled a comprehensive strategy for the development of a genetic prostate cancer prognostic test (http://nnw.fm/T2RyY). Developed by ProstaGene, an entity that CytoDyn is in the process of acquiring, PCaTest has already demonstrated superior predictive ability in comparison to other genetic prostate cancer tests. The PCaTest employs 14 genetic biomarkers to provide an accurate prognosis of prostate cancer, with the help of a complex proprietary artificial intelligence algorithm.

Following the completion of the ProstaGene acquisition, which is expected to close during the fourth quarter of 2018, CytoDyn will initiate a clinical study aimed at establishing the superior qualities of the PCaTest compared with current genetic tests. CytoDyn expects research results within four months from the start of the clinical trial.

CytoDyn interim Chief Medical Officer Richard Pestell, developer of the PCaTest, said in a news release that, so far, this test has shown three to four times superior hazards ratio (a predictor of outcome) in comparison to other prognostic tests for prostate cancer. The statement is based on results from three studies (featuring a total of 348 patient samples).

Recent evidence raises concerns about the ability of current prognostic tests to distinguish whether prostate cancer will be aggressive or slowly growing, Pestell said. Such vital information about the makeup of the malignancy can be used by physicians to make adequate decisions about the treatment of a patient.

Tests available now rely on the detection of prostate-specific antigen (PSA). Elevated PSA in the blood provides a warning, but it is not 100 percent indicative of cancer. Patients who have high PSA levels detected multiple times need to undergo a prostate biopsy to confirm the existence of cancer. During the biopsy, 12 extracted tissue samples are used for standard testing. In the case of the PCaTest, a single sample will be sufficient.

CytoDyn President and CEO Nader Pourhassan said that his company plans to complete development of the PCaTest soon and with minimal cost to CytoDyn, so as to file for Food and Drug Administration approval in 2019.

Prostate cancer is a common ailment in older men, and, as the Western population ages, the incidence of this malignancy is expected to increase. According to a forecast presented in the European Urology journal, the incidence of prostate cancer will double by 2030 (http://nnw.fm/43yTw).

Early screening is effective for certain types of cancer, including prostate cancer, according to the American Cancer Society (http://nnw.fm/rM3aW). Frequent PSA screening every four years can significantly lower the risk of death from prostate cancer. This type of cancer typically grows very slowly, which helps with early detection and allows urologists to administer an adequate treatment.

Currently, apart from skin cancer, prostate cancer is the most common malignancy in American men (http://nnw.fm/WNA0a). In 2018, some 164,690 new cases of prostate cancer are expected to be diagnosed. The number of deaths from this malignancy is forecast to reach 29,430 during the year. At the same time, the five-year survival rate for patients diagnosed with early stage prostate cancer is 100 percent.

CytoDyn is a biotech company that develops a novel humanized CCR5 monoclonal antibody, PRO 140, for multiple therapeutic indications. The CCR5 receptor plays a vital role in the ability of HIV to enter and infect T-cells. It is also implicated in the metastasis of tumors, as well as immune-mediated illnesses. CytoDyn’s lead product candidate, PRO 140, is in advanced clinical development for the treatment of HIV in combination with other anti-retroviral therapeutics and also as a potential single-agent treatment for HIV. The company is also conducting a Phase 2 clinical study of PRO 140 as a potential treatment to prevent graft-versus-host disease following bone marrow transplantation. CytoDyn further plans to conduct clinical investigations with PRO 140 in the treatment of metastatic breast cancer, following the completion of its acquisition of ProstaGene.

For more information, visit the company’s website at www.CytoDyn.com

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