Kintor Pharma gets a nod for phase III trial of COVID-19 cure in Brazil

Clinical-stage biotechnology firm Kintor Pharmaceutical Ltd. recently announced the approval by ANVISA (the Brazilian Health Regulatory Agency) for the proxalutamide phase III clinical trial to treat hospitalized COVID-19 patients. This is the third pivotal study approved by ANVISA and sponsored by Kintor Pharma for treating coronavirus patients with proxalutamide.

For the unversed, proxalutamide is a nonsteroidal antiandrogen in development for the treatment of COVID-19, breast cancer, and prostate cancer.

The phase III trial, dubbed NCT05009732, is a double-blind, randomized, placebo-controlled, multi-regional clinical research that intends to effectively evaluate the safety and efficacy of proxalutamide in COVID-19 patients.

The trial is expected to test 1030 patients, with the primary endpoint being the assessment of time to sustained recovery by day 30, and the secondary endpoint is the 30-day mortality.

Dr. Youzhi Tong, Chairman, Founder, and CEO of Kintor Pharma mentioned that the approval of this study is another milestone for the company. They intend to perform a pivotal multi-regional clinical trial of proxalutamide for treating hospitalized coronavirus patients in over ten countries, he added.

Further expressing his views on the latest approval, he expressed that they are optimistic that this approval will carve the way for the company to apply for an emergency use authorization (EUA) and commercialization of proxalutamide for Covid-19 treatment in Brazil.

Kintor Pharma is currently conducting one phase III MRCT (multi-regional clinical trials) for COVID-19 inpatients, and two registered phase III MRCT of proxalutamide for coronavirus outpatients in various economies and regions including the European Union, Asia, South America (including Brazil), the United States.

The China-based firm also received an emergency use authorization (EUA) for proxalutamide to treat COVID-19 infection in hospitalized patients in Paraguay, sources cited.

About Kintor Pharmaceutical Ltd.

China-headquartered Kintor Pharma focuses on developing and commercializing a promising pipeline of new small molecule and biological treatments for androgen-receptor-related diseases with unmet medical needs, which includes COVID-19, alopecia and acne, liver, and breast cancers.

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https://www.prnewswire.com/news-releases/kintor-pharma-announces-brazils-anvisa-approves-phase-iii-clinical-trial-of-proxalutamide-for-the-treatment-of-hospitalized-covid-19-patients-301385154.html