Advanced Life Sciences’ Restanza Shows 100% Survival in Tularemia Pivotal Animal Study
CHICAGO, Dec. 16 /PRNewswire-FirstCall/ — Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced positive top-line results from a pivotal, non-human primate study of its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) against an inhaled lethal dose of tularemia. A 14-day course of Restanza achieved a 100% survival rate at the doses tested. All of the ten animals in the study that received 16 mg/kg once-a-day of Restanza (approximate to a human dose of 300 mg) within 24 hours after exposure to a lethal dose of inhaled tularemia survived while only one of the ten animals that received placebo survived.
“We believe that the impressive survival data in tularemia, combined with previously reported survival data in anthrax and plague, 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. “We believe that our company’s biodefense strategy represents a promising commercial opportunity and we are excited about the scope and pace of our progress to date. One of Restanza’s major differentiating advantages, and a key characteristic that has attracted US government interest, is its demonstrated breadth of activity against many lethal pathogens.”
Tularemia is a bacterial disease commonly transmitted to humans through contact with infected rodents or rabbits or through insects that carry Francisella( )tularensis, the causative agent of tularemia, which 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 plague.
The Working Group on Civilian Biodefense, an expert panel convened by the Center for Civilian Biodefense Studies at the Johns Hopkins Bloomberg School of Public Health, says that tularemia could pose serious consequences if aerosolized and used as a biological weapon and cites a World Health Organization study which projected estimates of 250,000 illnesses and 19,000 deaths in the event that a mass-casualty tularemia biological weapon were used against a modern city of 5 million people.(1)( ) Unlike anthrax, there is no FDA-approved vaccine available to protect against tularemia, and the only antibiotic treatments currently available for improving survival in the event of a tularemia outbreak are older agents, such as gentamicin and doxycycline.
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 Bacillus anthracis (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 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 tularemia disease mechanisms and to assess novel approaches for the prophylactic treatment of inhaled tularemia 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.
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.
(1) Journal of the American Medical Association (JAMA) Vol. 285 No. 21, June 6, 2001.
SOURCE Advanced Life Sciences Holdings, Inc.