SUZHOU, China, Sept. 26, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that on September 22 the Brazilian Health Regulatory Agency (ANVISA) granted an approval for the phase III clinical trial of proxalutamide to treat hospitalized COVID-19 patients. This is the third ANVISA-approved pivotal study sponsored by Kintor Pharma for the treatment of COVID-19 patients with proxalutamide.
The phase III trial (NCT05009732) is a randomized, double-blind, placebo-controlled, multi-regional clinical study, which is expected to enroll 1,030 patients, designed to evaluate the efficacy and safety of proxalutamide in hospitalized COVID-19 patients. The primary endpoint of the trial is the time to sustained recovery evaluated by day 30. The secondary endpoint of the trial is 30-day mortality.
Dr. Youzhi Tong, founder, Chairman, and CEO of Kintor Pharma, commented, "The approval of this study represents another milestone for Kintor Pharma. We have been planning to conduct the pivotal multi-regional clinical trial of proxalutamide for the treatment of hospitalized COVID-19 patients in more than ten countries. With this third approval by ANVISA, Brazil becomes the fourth country to approve the proxalutamide clinical trial after the United States, China and Philippines. We are hopeful this approval will pave the way for Kintor Pharma to apply for an emergency use authorization (EUA) and the eventual commercialization of proxalutamide for the treatment of COVID-19 in Brazil."
About Proxalutamide (GT0918)
Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — that is under development for the potential treatment of COVID-19, prostate cancer, and breast cancer. Targeting AR-ACE2/TMPRSS2 signal axis by proxalutamide could significantly inhibit the entry of the virus into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2. Meanwhile, proxalutamide promotes the clearance of pathogens and decreases inflammation by activating the Nrf2 pathway, which activates several antioxidative genes and proteins, and reduces the intensity of the cytokine response, which may be of clinical benefit to patients with COVID-19 infection.
Kintor Pharma is now conducting two registered phase III multi-regional clinical trials (MRCT) of proxalutamide for the treatment of COVID-19 outpatients, and one phase III MRCT for COVID-19 inpatients in countries and regions that include the United States, South America (including Brazil), the European Union, and Asia. Kintor Pharma was granted an emergency use authorization (EUA) for proxalutamide for the treatment of COVID-19 infection in hospitalized patients in Paraguay.
About Kintor Pharmaceutical Limited
Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia and acne. For more information, visit www.kintor.com.cn.
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