Intravenous Restanza shows positive pre-clinical study results

Officials with Advanced Life Sciences recently announced the result of pre-clinical studies for a new antibiotic that could potentially treat a number of bio-terror agents.

The intravenous formulation of the antibiotic Restanza will treat anthrax, plague and tuleremia, as well as other serious hospital infections, company officials said.

Restanza was administered as a single dose daily to rats in the pre-clinical trial. Initial results showed that the antibiotic was well tolerated and showed a tenfold greater plasma exposure when compared to oral administration, according to the study results.

Advanced Life Sciences Chairman and CEO Michael T. Flavin said that the study results were encouraging so far.

“Restanza has potential to be the first ketolide antibiotic to have an intravenous formulation available in the U.S.,” Flavin said. “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.”

Flavin also noted there is an urgent need worldwide to develop safe and effective antibiotics that can overcome resistance to drugs that are currently available.

Flavin said the next step will be to continue preclinical studies of Restanza in preparation of future Phase I clinical trials with healthy volunteers.