VANCOUVER, Washington, July 15, 2020 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), an advanced-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential for multiple therapeutic indications, announced today that it recently submitted a complete listing request package with The Nasdaq Stock Market to request an increase in the Company’s common stock. The Company believes that it meets the initial listing requirements for The Nasdaq Capital Market.®.
Nader Pourhassan, Ph.D., President and CEO of CytoDyn, commented: “While we realize that the regulatory review of our application to upgrade to Nasdaq will take several weeks, we believe that the Company is well positioned for success. As we move forward in evaluating our drug leronlimab, including upcoming results from the COVID-19 trials, we believe a listing on Nasdaq will enhance shareholder value by providing our shareholders with greater liquidity and by giving us greater access to capital markets, which will allow us to achieve our goal of bringing leronlimab to the market. “
About coronavirus disease 2019
CytoDyn has met its goal of enrolling 75 patients in its phase 2 clinical trial for COVID-19, a randomized clinical trial for the mild-to-moderate COVID-19 population in the US, and enrollment continues in its trial Phase 2b / 3 Randomized Clinical Trial for Serious and Seriously Ill Population of COVID-19 in Various Hospitals Across the Country.
SARS-CoV-2 was identified as the cause of an outbreak of respiratory disease first detected in Wuhan, China. The origin of SARS-CoV-2 that causes COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is generally transmitted from person to person through respiratory droplets, commonly as a result of coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some that cause disease in people and others that circulate in animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. COVID-19 symptoms can appear as little as two days or up to 14 days after exposure. The clinical manifestations in patients have varied from nonexistent to severe and fatal. At this time, there are minimal treatment options for COVID-19.
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two possible indications of leronlimab for fatal diseases. The first is as combination therapy with HAART for HIV-infected patients and the second is for metastatic triple negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastasis, and other diseases, including NASH. Leronlimab has completed nine clinical trials on more than 800 people, including meeting their primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
In the context of HIV / AIDS, leronlimab is a viral entry inhibitor; It masks CCR5, thereby protecting healthy T cells from viral infection by blocking the predominant HIV subtype (R5) from entering those cells. Leronlimab has undergone nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control the HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent that leads to potentially fewer side effects and less frequent dosage requirements compared to daily drug therapies currently in use.
In the cancer context, research has shown that CCR5 may play a role in tumor invasion, metastasis, and control of the tumor microenvironment. Increased expression of CCR5 is an indicator of disease status in various types of cancer. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced metastasis from human breast cancer by more than 98% in a murine xenograft model. Therefore CytoDyn is conducting a phase 1b / 2 human clinical trial in metastatic triple negative breast cancer and was awarded the Fast Track designation in May 2019.
The CCR5 receptor appears to play a central role in modulating immune cell traffic to sites of inflammation. It can be crucial in the development of acute graft-versus-host disease (GVHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GVHD without significantly affecting transplantation of transplanted bone marrow stem cells. CytoDyn is conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor in grafted cells is critical to the development of acute GvHD, since the CCR5 receptor does not recognize specific immune signaling molecules. a viable approach to mitigate acute GvHD. The FDA has granted the leronlimab “orphan drug” designation for the prevention of GVHD.
About CytoDyn
CytoDyn is an advanced-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a new humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in HIV’s ability to enter and infect healthy T cells. The CCR5 receptor also appears to be implicated in tumor metastases and immunomediated diseases, such as GvHD and NASH. CytoDyn has successfully completed a fundamental phase 3 trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment experienced patients. The Company is working diligently to provide the information required by the FDA to resubmit its Biological Products License Application for this combination therapy. CytoDyn is also conducting a phase 3 research trial with leronlimab as monotherapy once a week for HIV-infected patients. CytoDyn plans to initiate a registry-led study of leronlimab monotherapy indication. If successful, it could support a tag extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral load in people infected with HIV. No serious drug-related injection reactions were reported in approximately 800 patients treated with leronlimab, and no drug-related SAEs were reported in patients treated with a 700-mg dose of leronlimab. In addition, a phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral leakage in HIV-infected patients; Some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a phase 2 trial to evaluate leronlimab for the prevention of GvHD and a phase 1b / 2 clinical trial with leronlimab in triple negative metastatic breast cancer. More information is in www.cytodyn.com.
Forward-looking statements
This press release contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions that reflect optimism, satisfaction or disappointment with current perspectives, as well as words such as “believe”, “wait”, “try”, “estimate”, “wait”, “projects”, “plans”, “anticipate” and variations thereof, or the use of the future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, possible results of clinical trials, studies, or other programs or the ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results may vary materially from those contained or expressed in such statements due to risks and uncertainties including: (i) the adequacy of the Company’s cash position , (ii) the Company’s ability to raise additional capital to finance its operations, (iii) the Company’s ability to meet its debt obligations, if applicable, (iv) the Company’s ability to establish association or license agreements with third parties, (v) the Company’s ability to identify patients to enroll in their clinical trials in a timely manner, (vi) the Company’s ability to achieve FDA approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the Company’s clinical trial results, including the possibility of clinical trial results des favorable, (ix) the market and commercialization of any approved product, (x) the existence or development of vaccines, medications or other treatments that medical professionals or patients consider superior to the Company’s products, (xi) initiatives regulatory, compliance with government regulations and the regulatory approval process, (xii) general economic and trade conditions, (xiii) changes in foreign, political and social conditions, and (xiv) various other matters, many of which are outside the scope of Company control. The Company urges investors to specifically consider the various risk factors identified in its most recent Form 10-K, and any risk factors or warning statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company assumes no responsibility to update forward-looking statements to account for events or circumstances that occur after the date of this press release.
CYTODYN CONTACTS
Investors:
Cristina De Leon
Office: 360.980.8524, ext. 106
Mobile: 503.214.0872
[email protected]
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