CHICAGO, Aug. 31 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , 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.
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.
Restanza as a Biodefense Countermeasure
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.
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.
About Advanced Life Sciences
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.
Photo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO
http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.comAdvanced Life Sciences Holdings, Inc.
