Nov 2 2010
Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that it has entered into a Cooperative Research and Development Agreement ("CRADA") with The Walter Reed Army Institute of Research. The purpose of this CRADA is to allow The Walter Reed Army Institute of Research to perform advanced animal efficacy testing of Restanza™ (cethromycin), the Company's novel oral antibiotic, against various Plasmodium species that cause malaria. This CRADA is built on the positive in vitro and in vivo efficacy results that Restanza demonstrated in initial studies with Walter Reed.
"Developing new treatments for malaria is a high-priority for the US military because of malaria's global prevalence, debilitating nature, potential lethality, and tendency to become resistant to current drugs," stated Michael T. Flavin, Ph.D., chief executive officer of Advanced Life Sciences. "We share the US Army's mission to protecting our troops in the field with novel therapies that can combat infectious diseases such as malaria. Advanced Life Sciences remains committed to developing Restanza as a new drug to protect public health and we are very pleased to expand our collaboration with the Walter Reed Army Institute of Research toward this goal."
In May 2010, the Company announced that preliminary in vitro and in vivo studies had been conducted to access the efficacy of Restanza against the species of Plasmodium that cause malaria. In the in vitro study comparing Restanza to azithromycin, Restanza showed 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. Most notably, in the in vivo study, Restanza showed 100% efficacy in treating mice infected with Plasmodium berghei and was approximately three-fold more potent than azithromycin at half of the same dose.
SOURCE Advanced Life Sciences Holdings, Inc.