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Wednesday, 08/15/2018 6:07:19 AM

Wednesday, August 15, 2018 6:07:19 AM

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CytoDyn Announces Strong Preclinical Results Using PRO 140 in Human Colon Carcinoma

CytoDyn will file an IND, along with a proof-of-concept protocol for colon cancer

PRO 140 shown effective in inhibiting human colon carcinoma growth

VANCOUVER, Washington, Aug. 15, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, announces that PRO 140 (leronlimab) has been shown effective at inhibiting the growth of a human colon carcinoma cell line (SW480) in a prominent mouse model. The results were statistically significant and provide the basis for filing an Investigative New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a clinical trial in colon carcinoma patients.

Two different strains of immunoincompetent mice were used to grow SW480 human tumor cells and different doses of PRO 140 were used in these studies. The SW480 cell line was derived from a patient with colon adenocarcinoma and, like many human cancers, was CCR5-positive. PRO 140 extended the life of treated mice and decreased tumor growth compared to control mice by greater than 50%, which was statistically significant. These results were dose dependent and were repeated in separate experiments. Current ongoing preclinical studies are defining the mechanisms involved in the anti-tumor efficacy of PRO 140.

“We have been conducting these preclinical studies over the past year to better document the activity of PRO 140 against CCR5-expressing human tumors,” stated Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer. “We believe that CCR5 is a crucial receptor in the growth and invasiveness of human malignancies, and these studies support that premise. Along with our recent announcement regarding the potential of PRO 140 in metastatic breast cancer, we believe these results in colon cancer further support that PRO 140, if approved, may offer an important potential therapeutic option for patients with breast and colon cancer. We now plan to file an IND within the next few weeks to begin studies of PRO 140 for the treatment of colon carcinoma. We will also continue to explore the biological pathways involving CCR5 to identify other potential therapeutic opportunities for PRO 140.”

CytoDyn also noted that upon the closing of its proposed acquisition of ProstaGene, Richard G. Pestell, Ph.D., M.D., Chief Executive Officer of ProstaGene and President of the Pennsylvania Cancer and Regenerative Medicine Research Center, is expected to be appointed CytoDyn’s Chief Medical Officer.

“We look forward to Dr. Pestell joining our team and leveraging his decades of research with the CCR5 receptor as we further explore opportunities for PRO 140 in cancer, immunology and autoimmune disorders,” added Dr. Pourhassan.
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