Advanced Life Sciences’ Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study
“The successful outcome of the study provides strong evidence of Restanza’s life saving potential and underscores its value as a potent new biodefense countermeasure,” said Dr.
Restanza as a Biodefense Countermeasure
Advanced Life Sciences is developing Restanza for the post-exposure prophylactic treatment of inhalation anthrax to help protect against human infection from anthrax. In studies conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Restanza was shown to be highly active in vitro against 30 strains of anthrax. In
In addition to its development in anthrax, Restanza is also being developed to combat other high priority bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two year,
FDA’s “Animal Efficacy Rule” and the Use of Non-Human Primates
The “Animal Efficacy Rule” allows for approval of new drug products based on animal data when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the “Animal Efficacy Rule” is subject to certain post-approval commitments, including the submission of a plan for conducting post-marketing studies, post-marketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the product’s approval was based on efficacy studies conducted in animals alone.
The non-human primates used in the study referenced above were used to help understand anthrax disease mechanisms and to assess novel approaches for the prophylactic treatment of inhalation anthrax in lieu of human efficacy testing pursuant to FDA’s “Animal Efficacy Rule” (21
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. For more information, please visit us on the web at www.advancedlifesciences.com
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences’ filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
SOURCE Advanced Life Sciences Holdings, Inc.