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CytoDyn is simultaneously finalizing an EUA application with the Philippine FDA with patient data from CD10 and recent eINDs for severe-to-critical patients
VANCOUVER, Washington, Dec. 15, 2020 (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 it had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.
On October 20, 2020, following review and recommendation by the Data Safety Monitoring Committee (DSMC) of data from 195 patients, the Company continued the trial without modification to achieve the primary endpoint. The DSMC also requested a second review of the data after 75% (or 293) of the patients