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CytoDyn Inc. (CYDY) Finding Success in Trials of PRO 140 for Treatment of HIV/AIDS; Plans to Expand Clinical Investigations to Cancer

  • Lead product candidate, PRO 140, is a viral-entry inhibitor that works by blocking the entry of HIV/AIDS to healthy cells by masking CCR5 receptor
  • Completion of Biological License Application (BLA) for potential approval in combination HIV therapy expected in Q1 2019
  • CytoDyn received approval to increase dosing of PRO 140 in its phase 3 adaptive clinical trial for enrolled HIV/AIDS patients
  • Market potential for PRO 140 as an anti-viral agent in combination with HAART is $1.2 billion; as a monotherapy maintenance/single-drug therapy, the market is estimated at $3.8 billion
  • Acquisition of privately held ProstaGene expected to complete in November, giving CytoDyn access to CCR5 technologies related to cancer
  • PRO 140 set for Investigational New Drug (IND) application in first cancer indication

Biotechnology company CytoDyn Inc. (OTCQB: CYDY) is focused on providing real hope and help to the millions of people infected with the human immunodeficiency virus (HIV) and those suffering from several devastating forms of cancer. The company’s lead product candidate, PRO 140 (leronlimab), is in advanced stages of clinical development as a therapy for HIV/AIDS, and plans to expand investigations with PRO 140 into cancer are underway. Nader Pourhassan, Ph.D., president and CEO of CytoDyn, updated shareholders during a recent conference call that was highlighted in a corporate summary from leading independent small cap media portal EmergingGrowth.com (http://nnw.fm/Lm4Xb).

The summary includes highlights from the ongoing clinical development of CytoDyn’s PRO 140 viral-entry inhibitor, which has demonstrated a 93 percent suppression rate in 525mg trials after a six-week induction period of enrolled HIV/AIDS patients. The data suggests that the higher the dosage of PRO 140, the quicker the drug drives a durable response, with a lower probability of a viral rebound, EmergingGrowth.com’s summary states.

HIV targets the immune system and weakens the body’s defense systems against infections and some types of cancer. During 2017, some 1.8 million people became newly infected with HIV, bringing the global total to 36.9 million people living with HIV, according to the World Health Organization (http://nnw.fm/043wY). HIV continues to be a major public health issue, having claimed more than 35 million lives so far from every corner of the world. The market potential for PRO 140 used as an anti-viral agent in combination with a patient’s current HIV regimen (Highly Active Antiretroviral Therapy, or “HAART”) is $1.2 billion; as a monotherapy maintenance/single-drug therapy, the market is estimated at $3.8 billion.

CytoDyn also recently signed a definitive agreement to acquire privately held ProstaGene. The deal, expected to be finalized in November, transfers or assigns to CytoDyn certain intellectual property rights held by ProstaGene and its founder and CEO Richard G. Pestell, M.D., Ph.D., M.B.A., F.A.C.P., F.R.A.C.P., who has joined CytoDyn as its interim chief medical officer (http://nnw.fm/7e5XX). ProstaGene is developing metastasis-control technology that targets the chemokine receptor type 5 (CCR5), a protein on the surface of white blood cells. Metastasis is the spread of cancer beyond the original tumor, a phenomenon that contributes to the disease’s deadliness. Preclinical studies have suggested that the use of CCR5 antagonists, such as PRO 140, as adjuvants may bolster anti-tumor immune responses.

“We are honored to soon have world-renowned cancer researcher Dr. Richard Pestell join CytoDyn as our Chief Medical Officer, with responsibility for leading all PRO 140 programs in non-HIV indications,” Pourhassan said in a news release. “We also have taken this important next step to acquire ProstaGene, which will allow Dr. Pestell to accelerate his CCR5 antagonist research related to cancer. As previously stated, our objective is to evaluate PRO 140 in expanded indications including certain cancers and immunological indications concurrent with advancing our promising HIV programs.”

CytoDyn has been conducting recent efforts to generate capital through the sale of shares and the exploration of non-dilutive licensing pathways and acquisition of related licensing rights for ProstaGene’s innovative prostate cancer prognostic test. The company expects this genetic test to add significantly to the company’s portfolio and, if successfully commercialized, to compete favorably with existing marketed prognostic cancer tests “that the competitor sells for $3,000.”

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

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