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Kintor Pharma announced today that the Phase III clinical trial of Proxalutamide (for the treatment of hospitalized COVID-19 patients) conducted on October 1 has recruited and administered the first patient in the United States
.
Proxalutamide is the only small molecule oral drug that has entered phase III MRCT clinical trials for the treatment of hospitalized COVID-19 patients
COVID-19
The US Phase III trial is a randomized, double-blind, placebo-controlled, multi-regional pivotal trial designed to evaluate the efficacy and safety of proxalutamide in hospitalized COVID-19 patients
.
The primary endpoint of the trial is the duration of recovery assessed on day 30, and the secondary endpoint of the trial is 30-day mortality
FDA
Proxalutamide is a non-steroidal anti-androgen (AR) drug, a selective high-affinity antagonist of the androgen receptor, and is being developed for potential treatment of COVID-19, prostate cancer and breast cancer
.
Proxalutamide targeting the AR-ACE2/TMPRSS2 signal axis can significantly inhibit virus entry into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2
Breast cancer Proxalutamide targeting the AR-ACE2/TMPRSS2 signal axis can significantly inhibit virus entry into host cells by transcriptionally down-regulating the expression of TMRPSS2 and ACE2
Dr.
Youzhi Tong, founder, chairman and CEO of Kintor Pharma commented: “As an AR antagonist, proxalutamide has demonstrated a clear mechanism of action, including down-regulation of ACE-2 and TMPRSS2 proteins, increasing the expression of NrF-2 and inhibiting IL.
-6 and TNF-α, etc.
, thereby minimizing cytokine storm and tissue damage, which indicates that proxalutamide can be used as a possible method for the treatment of severe COVID-19 patients
.
”
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