60 Degrees Pharmaceuticals' study findings on tafenoquine have been published in Travel Medicine and Infectious Disease.
Researchers performed neurotoxicity studies on adult rats to determine the maximum tolerated dosages of tafenoquine, which is an investigational antimalarial agent. The studies indicated that the super-therapeutic doses did not result in neurologic toxicity.
The first study measured the rats' clinical, physical and central nervous system changes. The rats were divided into five groups of 10, with five males and five females in each group. Each rat received a single dose of tafenoquine. The dosages ranged from 0 mg/kg to 700 mg/kg. One male rat that received a dose of 700 mg/kg died on the sixth day of the study.
Based on the results of the first study, three groups of 24 rats each were dosed with tafenoquine. Each group consisted of 12 males and 12 females. The rats received a single dose of 125, 250 or 500 mg/kg tafenoquine succinate. A control group of nine male and nine female rats were dosed with 1 percent methylcellulose and 0.4 percent Tween 80 in distilled water. Two rats that received 500 mg/kg died on day seven or eight.
The study found no histopathologicial changes in the rats' brains up to the lethal single dose. The dosage amounts used in evaluating the neurotoxicity of tafenoquine were less than those that would be used in treating humans if the drug is approved for malaria prevention.
"We are committed to improving the health and lives of people around the world through developing products that can help treat and prevent tropical diseases," 60 Degrees CEO Dr. Geoffrey Dow said.
Alerts Sign-up