CHICAGO, July 8 /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 positive results from preclinical toxicology and pharmacokinetic studies of an intravenous (IV) formulation of its novel antibiotic, Restanza™ that support its use in a hospital setting.
Restanza IV was administered as a single dose up to 60 mg/kg/day, the highest dose tested. Results demonstrated Restanza IV was well tolerated and generated 10-fold greater plasma exposure compared to oral administration. The studies were conducted in rats in accordance with good laboratory practices (GLP). The increased bioavailability of Restanza IV may allow for the treatment of serious hospital infections as well as the treatment of bioterror pathogens, such as anthrax, plague and tularemia after signs and symptoms are present.
"Restanza has potential to be the first ketolide antibiotic to have an intravenous formulation available in the U.S.," said Michael T. Flavin, Ph.D., Chairman and CEO. "Having an IV formulation allows for the potential treatment of serious hospital infections with an opportunity for an IV-to-pill switch as the patient moves from an in-patient setting to an outpatient setting. This is a significant feature that enhances the overall Restanza value proposition for physicians and patients."
Urgent Market Need for Potent Hospital-Based IV Antibiotics
There is an urgent market need in the U.S. and worldwide to identify and rapidly develop novel, safe and effective antibiotics that can overcome resistance to currently available drugs and that can be used in a variety of settings, such as an IV treatment in the hospital, and an IV-to-pill switch for stabilized patients and an oral treatment for outpatients.
Ketolide antibiotics, which represent a newer and promising class of therapeutics with greater potential against bacterial strains that are resistant to macrolides and penicillins, are typically very difficult to formulate in a clinically viable IV formulation due to low water solubility. Advanced Life Sciences has achieved a major breakthrough by successfully developing an IV formulation of Restanza. The formulation can be stored in a stable powder form and reconstituted on site in the hospital. The key features of this formulation support developing Restanza IV for use in the hospital setting.
The next step in the program is to initiate additional IND-directed preclinical studies of the Restanza IV formulation to support future Phase I clinical trials in normal healthy volunteers to evaluate its safety and pharmacokinetics.
Restanza is a novel oral once-a-day antibiotic that is in late stage development for the treatment of community acquired bacterial pneumonia and biodefense pathogens such as anthrax. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria including CA-MRSA and pathogens associated with respiratory tract infections that are resistant to penicillins, macrolides, and fluoroquinolones. 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 oral once-a-day 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.