CHICAGO, Aug. 31 Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced positive results from an animal study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) that was conducted to measure Restanza's therapeutic efficacy in treating inhalation anthrax after symptoms of infection had developed. The results of the placebo-controlled non-human primate study showed that a 14-day course of Restanza achieved up to a 60% survival rate when administered after animals demonstrated clinical symptoms of anthrax infection as a result of an inhaled dose of aerosolized anthrax spores that was 200 times the median lethal dose of anthrax. None of the animals that received placebo survived. Due to the extreme lethality of anthrax infection once symptoms appear, Restanza's ability to achieve a 60% survival rate is clinically and statistically significant. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), which is a component of the Department of Health and Human Services (HHS), an agency of the U.S. Government.
Today, there are no approved antibiotics for therapeutic treatment of anthrax infection, and the only approved drugs are administered for post-exposure prophylaxis before the onset of symptoms. In the event of an inhalation anthrax attack, victims may not be aware that they are infected with anthrax until symptoms of anthrax are present. The initial clinical signs and symptoms are nonspecific and may include malaise, headache, fever, nausea, and vomiting and are followed by a sudden onset of respiratory distress and chest pain. The onset of respiratory distress is followed by shock and death, with close to 100% mortality.
The results of this pivotal study complement previously reported efficacy results from two non-human primate studies showing that Restanza is highly effective in protecting animals from death after being infected with inhalation anthrax (post-exposure prophylaxis before the onset of symptoms). In those studies, Restanza achieved a 100% survival rate against an inhaled lethal dose of anthrax when treatment was initiated within 24 hours of challenge compared to 0% survival rate in placebo-treated animals.
Under the FDA's "Animal Efficacy Rule," drug sponsors must show that the treatment is effective in two animal species and must demonstrate safety in human clinical studies. The study results announced today will support the efficacy component of the Company's planned regulatory filing for marketing approval in anthrax. In addition, the safety database of over 5,000 human patients enrolled in over 50 clinical studies involving Restanza, which was validated in a positive 11-3 vote by a recent FDA advisory committee for the indication of community-acquired pneumonia, can support the safety component of the regulatory filing for marketing approval in anthrax.
"The successful outcome of this pivotal study, combined with our substantial data set showing the Restanza efficacy preventing anthrax infection post-exposure, provides strong validation of Restanza's broad utility as a life-saving treatment for anthrax and as a potent new biodefense agent," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "We believe that the government continues to be pleased with our progress and we anticipate achieving important milestones in our biodefense program in the near-term. We expect key data to be available and reported from our ongoing pivotal studies in plague and tularemia by the end of 2009. If these studies continue to confirm the product profile of Restanza as a potent broad spectrum medical countermeasure for biodefense, we plan to meet with the FDA to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment seeking marketing approval for the biodefense indications of anthrax, tularemia, and plague in the first part of 2010."
Restanza as a Biodefense Countermeasure
Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, but the FDA has not yet approved the drug for marketing in this or any other indication.
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, $3.8 million contract with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense.
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 anthrax disease mechanisms and to assess novel approaches for the prophylactic treatment of inhalation anthrax in lieu of human efficacy testing pursuant to the 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.
SOURCE Advanced Life Sciences Holdings, Inc.