Advanced Life Sciences Reports Positive Results From Animal Study Of Restanza

Advanced Life Sciences has reported positive results from an animal study involving its once-a-day, oral antibiotic Restanza (cethromycin) that was conducted to measure Restanza’s therapeutic efficacy in treating inhalation anthrax after symptoms of infection had developed.

The results of the placebo-controlled, non-human, primate study showed that a 14-day course of Restanza achieved up to a 60% survival rate when administered after animals demonstrated clinical symptoms of anthrax infection.

Reportedly, none of the animals that received placebo survived. Due to the extreme lethality of anthrax infection once symptoms appear, Restanza’s ability to achieve a 60% survival rate is clinically and statistically significant.

The study results are said to support the efficacy component of the company’s planned regulatory filing for marketing approval in anthrax.

Moreover, the safety database of over 5,000 human patients enrolled in over 50 clinical studies involving Restanza can support the safety component of the regulatory filing for marketing approval in anthrax.

Michael Flavin, chairman and CEO of Advanced Life Sciences, said: We believe that the government continues to be pleased with our progress and we anticipate achieving important milestones in our biodefense program in the near-term. We expect key data to be available and reported from our ongoing pivotal studies in plague and tularemia by the end of 2009.

If these studies continue to confirm the product profile of Restanza as a potent broad spectrum medical countermeasure for biodefense, we plan to meet with the FDA to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment seeking marketing approval for the biodefense indications of anthrax, tularemia, and plague in the first part of 2010.