Former President of the Philippines, Joseph Estrada, Among the Many COVID-19 Patients Receiving Leronlimab Under CSP in the Philippines
CytoDyn is following all patients treated with leronlimab under CSP and will provide additional information when available and authorized for release
VANCOUVER, Washington, April 19, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today former President of the Philippines, Joseph Estrada, was administered leronlimab under Compassionate Special Permit (CSP), among other medication, as a therapeutic for COVID-19. Mr. Estrada remains hospitalized and news reports indicate he may be transferred from ICU to a regular hospital room soon. CytoDyn continues to ship vials of leronlimab to the Philippines, while its distribution partner, Chiral Pharma Corporation, works closely with the Philippine FDA to consider expanding the CSP.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We have been working with Chiral Pharma for several months to provide COVID-19 patients in the Philippines access to leronlimab under CSP. CytoDyn is grateful for the opportunity to help the former President and his family and we wish him a full and speedy recovery. While we pursue emergency use authorizations in many countries and initiate final trials for the severe and critical COVID-19 patient populations to strengthen these applications, our teams remain hopeful their dedication and efforts will help COVID-19 patients around the world. We also are happy to report our BLA resubmission for HIV is on track and we are encouraged with the advancements in our expanding cancer program. I look forward to providing a full update to all of our stakeholders soon.”
About Leronlimab (PRO 140)
The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat HIV and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including NASH (nonalcoholic steatohepatitis). 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).