Advanced Life Sciences Submits Full Proposal To NIAID For Development Of Intravenous Formulation Of Restanza As A Biodefense Countermeasure
"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.
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 indications.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.
Source: Advanced Life Sciences Holdings, Inc