CytoDyn Announces Partnership with amfAR to Accelerate HIV Cure Research - Seite 2

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are honored to be in partnership with amfAR and the opportunities to accelerate a search for an HIV cure using this scientific premise. Timothy Brown’s cure ignited hope that a cure can happen through bone marrow transplant from the rare individuals with a delta-32 mutation. The success in our animal studies for HIV with Vyrologix (leronlimab) has provided this opportunity. We are very excited to be supporting this project, and to be a part of this groundbreaking endeavor with amfAR.”

About Coronavirus Disease 2019
CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Company’s website under the “Clinical Trial Enrollment” section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and is expected to occur again now that the Company has reached enrollment of 293 patients.

About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a 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 metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients). 

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.