SUZHOU, China, Jan. 28, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited (HKEX: 9939) is pleased to announce that the clinical trial (the "Trial") of Proxalutamide's treatment of hospitalized COVID-19 patients was approved by the Institutional Review Board ("IRB") of Brazil. The trial was accepted for accelerated review. We have received support from the Brazilian government in terms of medical resources allocation and expect to start with the patients recruitment over the coming weekend.
The Trial is a double-blinded, randomized and multi-center investigational study of Proxalutamide's treatment for hospitalized COVID-19 male and female patients of 18 years old or above. Approximately 588 patients (294 male and 294 female) who meet the eligibility criteria will be enrolled within 48 hours of admission to hospital. The estimated time from screening to the end of the Trial for each patient will be 28 days. The Trial will have two cohorts of men and women and two arms of Proxalutamide Arm and Control Arm, respectively. The patients will be randomized to each arm at a ratio of 1:1. In the Proxalutamide Arm, patients will be orally administered Proxalutamide 300mg once daily (QD) for 14 days. In the Control Arm, patients will be orally administered placebo once daily (QD) for 14 days. Each arm will also receive standard of care as determined by the principal investigator at the site. The primary endpoint of the trial is the treatment efficacy of Proxalutamide arm relative to the Control arm as assessed by the WHO COVID-19 ordinal scale on day 14.
Dr. Tong Youzhi, the founder, chairman and CEO of Kintor Pharmaceutical, commented, "Based on the results that Proxalutamide could alleviate symptoms and has reduced hospitalization risk of 100% for male COVID-19 outpatients and 90% for female COVID-19 outpatients, respectively, we collaborated with our investigator and quickly initiated the clinical study of Proxalutamide for the treatment of hospitalized COVID-19 male and female patients. This Clinical Trial has received strong support from the Brazilian government and was granted with the accelerated review. We are actively initiating MRCT phase III registrational trials, so as to bring an effective treatment therapy to COVID-19 patients over the world."
