WEDNESDAY, July 6, 2022 (HealthDay News) -- An experimental drug used to fight cancer may reduce the risk of death for COVID-19 patients by roughly 55%, a new study suggests.
The drug, sabizabulin, has been found effective in aiding severely ill COVID-19 patients, more so than previously authorized drugs, researchers report July 6 in the New England Journal of Medicine.
Veru, the Miami-based drug developer, has applied to the U.S. Food and Drug Administration for emergency authorization. The approval would provide another avenue of treatment for hospitalized patients.
"This looks super impressive," Dr. Ilan Schwartz, an infectious disease expert at the University of Alberta, Canada, told the New York Times. "We have a small number of treatments for patients with severe disease that improve mortality, but another treatment that can further reduce deaths would be very welcome."
However, the sample size of the study was relatively small, with just 134 patients given the drug.
"Overall, I think this is very exciting, although I would welcome larger and independent confirmatory studies," said Schwartz, who was not involved in the study.
Taken as a pill, the drug blocks cells from building molecular cables meant to transport materials from one area of the cell to another. Sabizabulin was initially developed by researchers at the University of Tennessee to fight cancer by cutting out this sort of highway access between tumor cells, preventing rapid growth.
But the drug appears to work in COVID patients by reducing life-threatening lung inflammation.
The trial included patients who were hospitalized for COVID treatment and receiving oxygen or mechanical ventilation. They had other risk factors such as obesity or high blood pressure that contributed to their high risk of dying from the disease. Because of this, they were allowed to be treated with other medications, such as steroids like dexamethasone, which is said to reduce death risk from COVID by one-third.
But out of the 134 volunteers who took the drug and the 70 who received a placebo, the death rates of the two groups were drastically different after 60 days. More than 45% of the placebo group died compared to about 20% of those taking sabizabulin -- a 55% reduction in the overall risk of death.
Dr. David Boulware, an infectious disease expert at the University of Minnesota who spoke with the Times, noted that the placebo death rate was alarmingly high. In contrast, he pointed to a trial of an arthritis drug given to COVID patients where less than 8% of the placebo group died.
A few antiviral drugs have been shown to keep COVID patients out of the hospital, but they generally don't work well with moderate to severe COVID, experts say. Paxlovid is one such drug usually given in the early course of the disease.
Veru said it halted the trial ahead of schedule because an independent advisory committee found the drug so effective that it would be unethical to continue giving some patients a placebo.
However, "trials which are stopped early routinely overestimate the effect," Boulware told theTimes. "I would be skeptical that the effect is 55%."
The U.S. Food and Drug Administration outlines current COVID-19 treatments.
SOURCE: New York Times, July 6, 2022
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