Non-human primate study results of Restanza released

Sep 30 2009

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced positive top-line results from a pivotal, non-human primate study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) demonstrating statistical significance at a 90% survival rate against an inhaled lethal dose of plague. The study tested Restanza's protective efficacy at various doses up to 64 mg/kg, where nine out of ten animals in the study that received a 14-day course of Restanza initiated within 24 hours after exposure to a lethal dose of plague survived while only one out of ten of the animals that received placebo survived.

Known as the "black death," a plague epidemic decimated Europe in the Middle Ages, killed more than 10 million people in India a century ago and today mainly affects people who come into contact with infected rodents. In weaponized form, plague could be engineered to resist antibiotic intervention and to be widely spread through human transmission. Yersinia pestis, the causative agent of plague, is classified by the Centers for Disease Control as a Category A Bioterrorism Agent and is prioritized by the Department of Defense and Department of Health and Human Services as one of the most serious biological weapons, along with anthrax and tularemia.

The Johns Hopkins Working Group on Civilian Biodefense notes that because of "the availability of Y. pestis around the world, capacity for its mass production and aerosol dissemination, difficulty in preventing such activities, high fatality rate of pneumonic plague, and potential for secondary spread of cases during an epidemic, the potential use of plague as a biological weapon is of great concern." Unlike anthrax, there is no FDA-approved vaccine available to protect against plague, and the only antibiotic treatments currently available for improving survival in the event of a plague outbreak are older agents, such as tetracycline and doxycycline.

"We believe that the impressive survival data in plague, combined with previously reported survival data in anthrax and tularemia, confirm the profile of Restanza as a potent, broad spectrum medical countermeasure for biodefense and underscore Restanza's impressive efficacy and safety against lethal pathogens which could represent significant threats to public health and safety," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Through our work with the U.S. government, we continue to advance Restanza toward potential registration as a new biodefense agent. Achieving regulatory approval for Restanza could lay the groundwork for securing important government stockpiling contracts that could bring significant value to our company. We plan to meet with the FDA in the coming months to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment in the first part of 2010 seeking marketing approval for the biodefense indications of anthrax, tularemia, and plague."

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense to combat multiple high priority bioterror agents, such as anthrax, Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two-year, $3.8 million contract with the U.S. Department of Defense. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, plague and tularemia, but the FDA has not yet approved the drug for marketing in this or any other indication.

FDA's "Animal Efficacy Rule" and the Use of Non-Human Primates

The FDA's "Animal Efficacy Rule" allows for approval of new drug products based on animal datawhen 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 C.F.R. Section 314.600-650). The study referenced above was carried out in accordance with the Animal Welfare Act (AWA) under the supervision of an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the AWA.

SOURCE Advanced Life Sciences Holdings, Inc.