Kintor Announced FDA Has Greenlighted Proxalutamide's Phase III Study for Hospitalized Male and Female COVID-19 Patients to Be Conducted; and (2) Inclusion of Female Outpatients in Proxalutamide's Phase III Study for Mild to Moderate COVID-19
SUZHOU, China, May 19, 2021 /PRNewswire/ -- On May 18, Kintor Pharmaceutical Limited (HKEX.9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the U.S. Food and Drug Administration (FDA) has greenlighted proxalutamide's phase III clinical trial of hospitalised COVID-19 patients to be conducted, which will recruit both male and female patients. Separately, the FDA agreed to the addition of female patients to its ongoing proxalutamide phase III clinical trial in outpatients with mild to moderate COVID-19 illness. The company will publish and update details of these pivotal studies at ClinicalTrials.gov.
Dr. Youzhi Tong, Founder, Chairman, and CEO of Kintor Pharmaceuticals, commented, "We have been planning to conduct a pivotal multi-regional clinical trial of proxalutamide for the treatment of hospitalised COVID-19 patients in approximately ten countries. That the US FDA greenlighted the proxalutamide phase III clinical trial for hospitalised patients to be conducted paves the way for us to accelerate the study process. At the same time, the FDA agreed to include female subjects in our ongoing phase III clinical trial of outpatients with mild to moderate COVID-19 illness. We look forward to reporting proxalutamide's progress in helping to combat the global COVID-19 pandemic."
About Proxalutamide (GT-0918)
Proxalutamide is a nonsteroidal antiandrogen — specifically, a selective high-affinity silent antagonist of the androgen receptor — under development for the potential treatment of COVID-19 and prostate and breast cancer.
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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SOURCE Kintor Pharmaceuticals
Company Codes: HongKong:9939