First Compassionate Special Permit (CSP) Patient in Philippines Improved Significantly 35 hours After First Injection of Leronlimab and Released 3 Days Later
VANCOUVER, Washington, April 05, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix
(leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first Compassionate Special Permit (CSP) patient in the Philippines
improved significantly 35 hours after receiving a 700 mg injection of Vyrologix under a licensed physician’s request for CSP to treat COVID-19 patients.
The CSP patient spent 10 days on high flow oxygen, was treated with multiple doses of dexamethasone and then tocilizumab during that period and did not improve. The physician in charge of the patient was pleased to report that, 35 hours after the subcutaneous injection of leronlimab, the patient was removed from high-flow oxygen and was breathing on his own. The patient was discharged from the hospital on Saturday, April 3.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are very pleased to see Vyrologix (leronlimab) used in the first patient in the Philippines. We are ready to ship more product for any patients who request leronlimab under CSP in the Philippines. I want to reiterate our commitment to the Philippines of at least 100,000 doses upon the FDA Philippines granting Emergency Use Authorization (EUA). We believe this anecdotal data and more than 90 approved eINDs (emergency IND) in U.S. along with the results of our CD12 of 384 mITT (modified intent to treat), double blinded study that had 82% reduction in 14-day mortality of critically ill, mechanically ventilated patients with statistically significant p-value is a compelling reason to move forward with the EUA request in the Philippines. We are very thankful our partners at Chiral Pharma were able to help with this patient.”
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).