- Preclinical data shows Restanza to be effective against gonorrhea -
CHICAGO, May 28 /PRNewswire-FirstCall/ -- 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 the expansion of its collaboration with the U.S. Government to include the evaluation of Restanza's activity against sexually transmitted infections (STI's), such as gonorrhea. Under the expanded agreement, Restanza's in vitro activity against Neisseria gonorrhoeae and other key STI's will be assessed, with the potential to advance Restanza into clinical development in government-sponsored clinical trials.
The activity of Restanza has been evaluated against 148 N. gonorrhoeae isolates and demonstrated significant in vitro activity as measured by minimal inhibitory concentration (MIC), the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism. Restanza was comparable in activity to azithromycin and ciprofloxacin and superior to erythromycin and clarithromycin, the antibiotics commonly used to treat gonorrhea infections.
"We believe that Restanza has demonstrated significant promise as a potent treatment for gonorrhea and other sexually transmitted infections and we are excited to expand our partnership with the U.S. Government beyond biodefense to further explore its therapeutic activity," said Dr. Michael T. Flavin, Chief Executive Officer. "Conventional antibiotic approaches are proving to be ineffective against drug-resistant strains of gonorrhea, thus increasing the urgent need for new antibiotic interventions to combat this growing global public health threat. Restanza's broad activity against community-acquired, bioterror and other bacterial pathogens make it an ideal candidate for government-supported development. We look forward to partnering with the government to address this important health challenge."
Gonorrhea is a sexually transmitted infection caused by the bacterium Neisseria gonorrhoeae. The Centers for Disease Control and Prevention (CDC) estimates that more than 700,000 people in the U.S. contract new gonorrheal infections each year. After a period of decline following the implementation of the national gonorrhea control program in the mid-1970s, the national gonorrhea rate has continued to increase. The development of antimicrobial resistance in N. gonorrhoeae is a growing public health concern, in particular because only one remaining class of antibiotics, the cephalosporins, is recommended by the CDC for its treatment. Ongoing data from CDC's surveillance project show that fluoroquinolone-resistant gonorrhea is now widespread in the United States. As a consequence, the CDC recommends against using fluoroquinolones such as ciprofloxacin and levofloxacin in the treatment of gonorrhea.
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 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.
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. The Company's lead candidate, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.
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.