Advanced Life Sciences Submits Full Proposal to NIAID for Development of Intravenous Formulation of Restanza as a Biodefense Countermeasure
PR Newswire “Press Releases US – English “
CHICAGO , Nov. 9, 2010 /PRNewswire/ — Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that it has submitted a full proposal to the National Institute of Allergy and Infectious Diseases (NIAID) under BAA-NIAID-DMID-NIHAI2010097 Development Of Therapeutics For Biodefense. It is anticipated that one or more awards will be made from this solicitation and that the awards will be made on or about July 29, 2011 .
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“We are pleased to have submitted a full proposal to NIAID which, if awarded, could significantly advance the development of the intravenous (IV) formulation of Restanza (cethromycin) for the therapeutic treatment of bioterror pathogens as well as for the commercial indication of community acquired bacterial pneumonia,” stated Michael T. Flavin , Ph.D., chief executive officer of Advanced Life Sciences . “In addition to the efficacy demonstrated by the oral form of Restanza for post-exposure prophylaxis of anthrax, plague and tularemia, the oral form of Restanza has also shown initial efficacy in treating anthrax infection where symptoms are present. This is significant because there are currently no agents approved by the FDA for the therapeutic treatment of anthrax, plague or tularemia and we believe that the increased bioavailability of the IV formulation of Restanza offers a promising option as a therapeutic treatment for these infections.”
The Company’s proposal 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.