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開 拓 藥 業 有 限 公 司 *
KINTOR PHARMACEUTICAL LIMITED
(Incorporated in the Cayman Islands with limited liability)
(Stock code: 9939)
FIRST PATIENT ENROLMENT FOR THE COVID-19 STUDY OF
PROXALUTAMIDE WITH APPLIED BIOLOGY
This is a voluntary announcement made by Kintor Pharmaceutical Limited (the "Company" and together with its subsidiaries, the "Group"). Reference is made to the announcement dated 12 July 2020 (the "Announcement") on the Research Agreement between Applied Biology, Inc. ("Applied Biology") and the Company to conduct research for Proxalutamide (GT0918) as a treatment for the coronavirus disease ("COVID-19") (the "Clinical Trial"). Unless otherwise defined herein, the capitalised terms shall have the same meaning as those defined in the Announcement.
The board (the "Board") of directors (the "Directors") of the Company is pleased to announce that on 20 August 2020, the Clinical Trial (ClinicalTrials.gov identifier: NCT04446429) has recorded the first patient enrolment in Brazil.
The Clinical Trial is a prospective, interventional, placebo controlled, double-blinded, randomised parallel assignment study exploring the anti-androgen treatment for COVID-19. The Clinical Trial is consisted of two experimental arms of Dutasteride plus standard care (the "Dutasteride Arm") and Proxalutamide plus standard care (the "Proxalutamide Arm") and one active comparator arm of placebo plus standard care (the "Controlled Arm"). Ivermectin + azithromycin are used as standard care given there has been no approved medication for coronavirus patients. For the purpose of exploring the possible protective role of anti-androgens in COVID-19 infections, 381 male study subjects aged 50 years old or above and present with androgenetic alopecia are estimated to be enrolled in the Clinical Study with 127 patients in each of the Dutasteride Arm, the Proxalutamide Arm and the Controlled Arm, respectively. It is estimated that the Clinical Trial will complete by the end of January 2021.