Made a move off bottom Friday.
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Back at the end of July the FDA failed to approve the new drug Restanza(TM) (cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). because it said that although Restanza demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP, it voted that Restanza did not demonstrate efficacy in the treatment of CAP and did not include enrollment of moderate-to-severe CAP patients. They stated that the new draft guidance for developing treatments for CAP, released in March, 2009, requires the enrollment of moderate-to-severe CAP patients for approval in the mild-to-moderate CAP indication.
Advanced Life Sciences' pivotal Phase 3 program included in the new drug application was designed and conducted under prior FDA guidance and before the new draft guidance was released. Advanced Life agreed to comply with the new guidelines and was moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed to satisfy the FDA's request for additional efficacy information.
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***In more recent developements about Restanza
Advanced Life Sciences' Restanza Demonstrates Efficacy in Treating Anthrax Infection
-Study Shows Restanza's Significant Efficacy After Symptoms of Anthrax Infection Are Present-
Press Release
Source: Advanced Life Sciences Holdings, Inc.
On Monday August 31, 2009, 9:00 am EDT
CHICAGO, Aug. 31 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS - News), 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.
...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.
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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
Advanced Life Sciences:Advancing Discoveries for Health.
ADLS - Advanced Life Sciences Holding, Inc (OTCBB Stock)
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