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Advanced Life Sciences Announces Successful Preclinical Data Supporting Restanza Intravenous Formulation for Hospital Use
Date:7/8/2010

tch 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.

About Restanza

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
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SOURCE Advanced Life Sciences Holdings, Inc.
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