Advanced Life Sciences has entered into a CRADA with The Walter Reed Army Institute of Research that allows the latter to perform advanced animal efficacy testing of Restanza (cethromycin) against the various species of Plasmodium that cause malaria.
Preliminary in vitro and in vivo studies have been conducted to test the efficacy of Restanza against different types of malaria-causing Plasmodium. The drug shows two- to ten-fold greater efficacy against Plasmodium falciparum, with the IC50 and IC90 levels, respectively, ranging from 0.2 to 2.7 and 0.6 to 6.2 ug/mL, regardless of chloroquine susceptibility, according to Advanced Life Sciences. In the in vivo study, Restanza has shown 100% efficacy in treating mice infected with Plasmodium berghei and is approximately three times more potent than azithromycin at half of the same dose.
"Developing new treatments for malaria is a high-priority for the U.S. military because of malaria's global prevalence, debilitating nature, potential lethality, and tendency to become resistant to current drugs," says Michael T. Flavin, CEO of Advanced Life Sciences. "We share the U.S. Army's mission to protecting our troops in the field with novel therapies that can combat infectious diseases such as malaria.”
Restanza is a once-a-day, oral antibiotic that is in late-stage development for the treatment of adults with mild-to-moderate community-acquired pneumonia and biodefense pathogens. Tests have shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, according to Advanced Life Sciences. The drug also appears to be effective against penicillin-, macrolide-, and flouroquinolone-resistant bacteria.
Restanza is also being investigated for the prophylactic treatment of inhalation anthrax postexposure and other high-priority biodefense pathogens including plague and tularemia.