[ad_1]
The results of the CD12 trial also indicated that five out of six patients on ECMO recovered
VANCOUVER, Washington, March 29, 2021 (GLOBE NEWSWIRE) – CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), an advanced biotechnology company developing Vyrologix ™ (leronlimab-PRO 140), a CCR5 antagonist with potential for multiple therapeutic indications, today announced the publication in the Journal of Translational Autoimmunity “Case Study of Critically Ill Person with COVID-19 on ECMO Successfully Treated with leronlimab” available at: https://doi.org/10.1016/j.jtauto.2021.100097.
Nader Pourhassan, Ph.D., President and CEO of CytoDyn, said: “We are very grateful to Sohier Elneil, MD, University College London, for his strong contribution to this important study and to Jacob Lalezari, MD, Quest Clinical Research, for its role based on its in-depth knowledge of leronlimab. This patient’s discharge from intensive care after prolonged ECMO support following administration of our drug is consistent with data from our recently completed Phase 3 trial in which five out of six patients on ECMO recovered and eIND for critically ill COVID-19 patients. We hope that this study will increase awareness of the benefits of leronlimab in the wider medical community. “
About Leronlimab (PRO 140)
The FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for severe disease. The first indication is combination therapy with HAART for patients infected with HIV and the second is triple negative metastatic breast cancer. Leronlimab is an experimental humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastasis and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal phase 3 trial (leronlimab in combination with standard antiretroviral therapy in previously treated HIV-infected patients).
In the context of HIV / AIDS, leronlimab is an inhibitor of viral entry; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV subtype (R5) from entering these cells. Leronlimab has been the subject of nine clinical trials, each of which has shown that leronlimab can significantly reduce or control the HIV viral load in humans. The leronlimab antibody appears to be a potent antiviral agent potentially resulting in fewer side effects and less frequent dosing requirements compared to the daily drug regimens currently in use.
Research has shown that CCR5 may play a role in tumor invasion, metastasis and control of the tumor microenvironment in the context of cancer. Increased expression of CCR5 is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastasis in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by over 98% in a murine xenograft model. CytoDyn is therefore conducting a phase 1b / 2 human clinical trial in triple-negative metastatic breast cancer and was granted Fast Track designation by the FDA in May 2019.
The CCR5 receptor appears to play a central role in modulating the traffic of immune cells to sites of inflammation. It can be crucial in the development of acute graft versus host disease (GvHD) and other inflammatory conditions. Clinical studies conducted by others further support the concept that blocking CCR5 using a chemical inhibitor may reduce the clinical impact of acute GvHD without significantly affecting bone marrow stem cell transplantation. bone transplanted. CytoDyn was conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on transplanted cells is essential for the development of acute GvHD, preventing the CCR5 receptor from recognizing specific immune signaling molecules is an approach viable to alleviate acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD. Due to the lack of patients during the COVID-19 pandemic, the company has suspended its Phase 2 trial for acute GvHD.
About CytoDyn
CytoDyn is an advanced biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to penetrate and infect healthy T cells. The CCR5 receptor also appears to be involved in tumor metastasis and immune-mediated diseases, such as GvHD and NASH.
CytoDyn has successfully completed a pivotal phase 3 trial with leronlimab in combination with standard antiretroviral therapy in previously treated HIV-infected patients. CytoDyn has worked diligently to file its Biologics License Application (“BLA”) for this HIV combination therapy since it received a refusal to file in July 2020 and then met with the FDA by phone to respond to its written instructions regarding the deposit. CytoDyn plans to offload its BLA in the first half of calendar year 2021.
CytoDyn has completed a phase 3 investigative trial with leronlimab as monotherapy once weekly for patients with HIV infection. CytoDyn plans to launch a study aimed at registering the indication for leronlimab as monotherapy. If successful, it can support label extension. Clinical results to date from several trials have shown that leronlimab can significantly reduce the viral load in people with HIV infection. No drug-related severe injection site reactions have been reported in approximately 800 patients treated with leronlimab, and no drug-related SAEs have been reported in patients treated with 700 mg 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 remained virally suppressed for more than six years.
CytoDyn is also conducting a Phase 1b / 2 clinical trial with leronlimab in triple negative metastatic breast cancer. More information on 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 phrases reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believes”, “hopes”, “intends”, “believes”, “expects”, “plans” “,” Plans “,” anticipates “and their variations, or use of the future, 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 results, the possible results of clinical trials, studies or other programs or the ability to continue such programs, the ability to obtain regulatory approval for commercial sales and the actual commercial sales market. The company’s forward-looking statements are not guarantees of performance, and actual results could differ materially from those contained or expressed by such statements due to risks and uncertainties, including: (i) the adequacy of the cash position of the company, (ii) the ability to raise additional capital to finance its operations, (iii) the ability of the company to honor its debts, if any, (iv) the ability of the company to enter into partnership agreements or licensing with third parties, (v) the company’s ability to identify patients to enroll in its clinical trials in a timely manner, (vi) the company’s ability to gain approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the Company’s clinical trial results clinical trials, including the possibility of adverse clinical trial results, (ix) the m archaeological and commercialization of any approved product, (x) the existence or development of vaccines, drugs or other treatments considered by healthcare professionals or patients to be superior to the Company’s products, (xi) regulatory initiatives, compliance with government 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 independent of the will of the Company. The Company urges investors to specifically consider the various risk factors identified in its latest Form 10-K, as well as any risk factors or caveats included in any subsequent Form 10-Q or Form 8-K, filed with of the Securities and Exchange Commission. Except as required by law, the Company assumes no responsibility to update forward-looking statements to reflect events or circumstances occurring after the date of this press release.
CONTACTS
Investors:
Michael mulholland
Office: 360.980.8524, ext. 102
[email protected]
Source link
