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Advanced Life Sciences Submits Full Proposal to NIAID for Development of Intravenous Formulation of Restanza as a Biodefense Countermeasure
Date:11/9/2010

sal requests $38 million over 5 years for the development of an IV formulation of its novel antibiotic, Restanza to therapeutically treat anthrax, tularemia and plague.  In addition, the proposal includes pre-clinical development as well as funding for four Phase 1 clinical trials and a Phase 2 clinical trial to evaluate the safety and efficacy of IV Restanza in patients hospitalized with moderate-to-severe community acquired bacterial pneumonia (CABP).

The Company recently announced positive results from preclinical toxicology and pharmacokinetic studies of an IV formulation of Restanza.  Restanza was administered intravenously as a single dose up to 60 mg/kg/day.  Results from this GLP study show that the IV formulation of Restanza was well tolerated and generated 10-fold greater plasma exposure compared to oral administration.  

About Restanza

Restanza is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of adults with mild-to-moderate community-acquired bacterial pneumonia ("CABP") and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indicati
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SOURCE Advanced Life Sciences Holdings, Inc.
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