Advanced Life Sciences announces positive results from preclinical studies of Restanza IV

Jul 8 2010

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.