CytoDyn’s Leronlimab Featured on OneNews in Philippines on May 9
Drs. Pourhassan, Recknor, Seethamraju and Nicolas will appear in a one-hour segment beginning at 5:00 pm PT / 8:00 pm ET, Sunday, May 9
VANCOUVER, Washington, May 07, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today its drug candidate, leronlimab, will be featured in a one-hour news segment on Sunday, May 9, at 5:00 pm PT / 8:00 pm ET on OneNews in the Philippines. CytoDyn has been supplying leronlimab to the Philippines as a therapeutic treatment for critically ill COVID-19 patients under Compassionate Special Permits (CSPs) authorized by the Philippine FDA.
Appearing in this news program will be Nader Pourhassan, Ph.D, CytoDyn’s President and Chief Executive Officer, Chris Recknor, M.D., CytoDyn’s Chief Operating Officer and Head of Clinical Development, Harish Seethamraju, M.D., Medical Director for the Mount Sinai Lung Transplantation Program in New York, and Richard Nicolas, M.D., Associate Clinical Professor for Cardiothoracic and Vascular Surgery, University of the Philippines, and practicing surgeon, St. Luke’s Medical Center, Philippines.
This news event can be accessed as follows:
Date: Sunday, May 9, 2021
Time: 5:00 pm to 6:00 pm PT / 8:00 pm to 9:00 pm ET
- Viewers are encouraged to login 30 minutes prior to the start time
OneNews.PH is the online presence of OneNews, the all-news channel of Cignal TV and the synergy of the journalistic strengths of The Philippine STAR, philstar.com, TV5 Network Inc. and BusinessWorld under Mediaquest Holdings Inc.
About Leronlimab (PRO 140)
Leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies.
CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn has been working diligently to resubmit its Biologics License Application ("BLA") for this HIV combination therapy since receiving a Refusal to File letter in July 2020 and subsequently meeting with the FDA telephonically to address their written guidance concerning the submission. CytoDyn expects to resubmit its BLA via a rolling submission starting in the third quarter of calendar 2021.
CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. More information is at www.cytodyn.com.
This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of 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 provide positive health outcomes, the possible results of clinical trials, studies or other programs or 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 could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary 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 does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.
Office: 360.980.8524, ext. 102
Released May 7, 2021