- Company Presents Data on Cethromycin Showing In Vivo Efficacy against Tularemia -
CHICAGO, March 19 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), a biopharmaceutical company developing cethromycin, a novel once-a-day antibiotic, to treat respiratory tract infections and to combat bioterror threats, announced today that it received notice from the Department of Defense (DoD) that it has exercised its option to award the Company $2.0 million under the previously announced contract to develop cethromycin as a broad-spectrum medical countermeasure.
The contract is funding NDA-enabling studies to evaluate cethromycin's efficacy in combating Category A and B bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis). Under the terms of the contract, $1.8 million of DoD funds were initially available to initiate the studies. The $2.0 million optional award announced today represents the remaining balance of the $3.8 million contract.
"DoD's decision to exercise its option to the full amount of the contract represents a strong vote of confidence in the potential of cethromycin as a biodefense therapy, and it enables us to complete pivotal studies to expand cethromycin's potential spectrum of activity in biodefense beyond the success that was demonstrated in preventing inhalation anthrax," stated Dr. Michael T. Flavin, chairman and chief executive officer of Advanced Life Sciences. "Since contract inception, we have strengthened our relationship with DoD and believe that cethromycin can ultimately meet the DoD's goal of protecting the Warfighter from the threat of biological warfare and bioterrorism."
The Company went on to announce today that it presented a poster at the recent ASM Biodefense and Emerging Diseases Research Meeting in Baltimore, Maryland. The poster, entitled "Efficacy of Cethromycin in A Murine-Aerosol Model of Francisella tularensis (ShuS4)," summarizes efficacy data demonstrating the potency of cethromycin against tularemia from a mouse study conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). Results of the mouse study suggested that treatment of cethromycin at 75 mg/kg over 21 days offered 100% protection from tularemia infection. USAMRIID concluded that cethromycin's preferential accumulation in the alveolar cells of the lungs, combined with the oral bioavailability and once a day dosing make cethromycin an attractive candidate for use in tularemia therapy.
Cethromycin is a novel once-a-day oral antibiotic under review for approval by FDA for the treatment of mild-to-moderate community acquired pneumonia (CAP). Cethromycin is part of a new class of antibiotics called ketolides. In addition to its utility in CAP, cethromycin is also being investigated for its use as a broad spectrum biodefense countermeasure. Cethromycin completed an efficacy study in which it was determined that a 30-day course of oral cethromycin was 100% protective against a lethal dose of inhaled anthrax as compared to the standard of care, Cipro(R) (ciprofloxacin), which demonstrated 90% protection. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post-exposure, but the FDA has not yet approved the drug for marketing in this or any other indication.
Francisella tularensis is the causative agent of tularemia in humans. Though clinical infection causes a spectrum of illness from a mild flu-like syndrome to a life-threatening infection, tularemia is a CDC Category A biologic threat agent due to high infectivity (infectious dose as low as 1-10 organisms), ease of spread by aerosol, and the potential to cause significant morbidity and mortality in infected persons.
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, respiratory diseases and biodefense. For more information, please visit us on the web at www.advancedlifesciences.com.
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. 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.
|SOURCE Advanced Life Sciences Holdings, Inc.|
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