An experimental drug for prostate cancer, proxalutamide, improved the recovery of Covid-19 patients and accelerated their recovery, according to a clinical trial in Brazil.
The drug, developed by the pharmaceutical company Kintor, blocks the effects of androgen hormones by inactivating the relevant receptors on the cell surface. The coronavirus protein must be amplified by a protein (TMPRSS2) regulated by cellular androgen receptors before it can enter and infect human cells. This non-steroidal drug inhibits this process, thus making it difficult for cells to become infected with the SARS-CoV-2 virus.
After two weeks, 81.4% of patients who had taken proxalutamide had recovered, compared with only 35.7% of those who had taken a placebo. After four weeks, almost half of the patients (49.4%) in the placebo control group had died, compared with only 11% of those who had received proxalutamide. Also the average recovery time was five days for the drug group, compared to ten days for the placebo group.
According to Kintor Pharmaceuticals, the Brazilian study is the third pivotal study of proxalutamide in the treatment of COVID-19 sponsored by the company. The Brazilian approval came along with the U.S. Food and Drug Administration’s (FDA) clearance of two pivotal trials studying proxalutamide’s treatment of U.S. COVID-19 outpatients and inpatients.
Dr. Tong Youzhi, the founder, Chairman, and CEO of Kintor Pharmaceutical, commented, “We are delighted to receive the approval from ANVISA and CONEP for this Brazilian phase III clinical trial of proxalutamide in COVID-19 patients. Once the previously reported results of the investigator-initiated trial (IIT) in Brazil became available, Kintor itself filed a pre-IND application with ANVISA as part of a multi-regional clinical trial. We look forward to continuing our positive relationship with the Brazilan regulators and expect this approval will pave the way for Kintor to apply for an emergency use authorization (EUA) and the eventual commercialization of proxalutamide for the treatment of COVID-19 in Brazil.”
Meanwhile, a record number of new coronavirus infections were recorded in Brazil on Wednesday, with the country’s Ministry of Health announcing that 115,228 cases of SARS-CoV-2 had been confirmed in the laboratory.
Another 2,392 patients with COVID-19 died in the same 24 hours.