Completion of Patients’ Recruitment for Proxalutamide’s COVID-19 Hospitalised Study

22-Feb-2021 Intellasia | PR Newswire Asia | 4:14 PM Print This Post

SUZHOU, China, Feb.22, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited (HKEX:9939) is pleased to announce that the clinical trial of Proxalutamide for the treatment of hospitalised COVID-19 patients in Brazil completed the recruitment of 588 patients. The data of the clinical trial is expected to be available in March 2021.

The clinical trial is a prospective, interventional, placebo controlled, double-blinded, randomised parallel assignment and multi-center study. 588 patients (294 male and 294 female) who meet the eligibility criteria will be recruited within 48 hours of admission to hospital. 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, "The 588 patients' recruitment has taken only three weeks which set another record. First of all, we would like to give special thanks again to Dr. Andy Goren, Dr. Flávio Adsuara Cadegiani and the team, who are working sleeplessly on this investigator initiated study in Brazil. The preliminary results from the compassionate use of Proxalutamide in ICU patients surprisingly indicated a reduction in the number of deaths and in ex-tubations. Following on these exciting preliminary results, we are actively initiating MRCT phase III registrational trials in Brazil, China and other countries in the near future."

About Kintor Pharmaceutical Limited

Founded in 2009, Kintor Pharmaceuticals aims to become a leading enterprise in the R&D and commercialization of "best-in-class" and "first-in-class" innovative therapies. The Company initially focused on androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as COVID-19, prostate cancer, breast cancer, liver cancer ,hair loss and acne. Kintor Pharmaceuticals has prospectively developed a diversified product pipeline that includes small molecule innovative drugs, bio-innovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as PD-L1/TGF-β dual-targeting antibody, AR-Degrader and c-Myc inhibitors that are undergoing preclinical research. Globally, the Company has more than 60 issued patents or under review, many of which are listed as the "Major New Drugs Discovery" in National 12th and 13th Five-Year Plans. On 22 May 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock ticker 9939.HK. Please visit http://www.kintor.com.cn for more information.

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