Advanced Life Sciences reaches SPA agreement with FDA for Restanza Phase 3 study

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, announced today that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study of its novel once-daily oral antibiotic Restanza™ to treat community acquired bacterial pneumonia (CABP).  The trial is the first prospectively designed superiority study to be conducted in CABP.

The double-blind pivotal superiority study will compare the efficacy and safety of once-daily oral administration of 300 milligrams of Restanza over seven days of treatment to azithromycin. The primary efficacy endpoint will be the clinical cure rate in a macrolide-resistant Streptococcus pneumoniae (MRSP) population. The protocol also includes several unique features, such as the inclusion of patient-reported outcome measures, which have the potential to generate a more robust demonstration of effectiveness and establish Restanza as a new standard of care in treating pneumonia.

With reported resistance rates as high as 40 percent to standard-of-care macrolide antibiotics in the U.S., there is a pressing medical need for new drugs to treat CABP. Based on the data Advanced Life Sciences has accumulated in its extensive pre-clinical and clinical program to date, coupled with a thorough review of published literature on the clinical relevance of macrolide resistance, the company believes that Restanza has the potential to show a superior efficacy advantage in patients who are resistant to marketed macrolide drugs.

"We are pleased that the FDA has agreed to a SPA which provides a clear pathway to approval for Restanza in the CABP indication, and which is designed to meet the needs of the community, industry and regulators," said Michael T. Flavin, Ph.D. CEO of Advanced Life Sciences.  "We believe that the superiority-based SPA represents a precedent-setting clinical trial design for oral antibiotics and will make a significant contribution to the field of CABP and antimicrobial clinical trial design. Regulators, industry and experts in the field have long recognized the need for clinical design protocols that will help to bring innovative and important antimicrobial therapies to the market. Advanced Life Sciences welcomes the opportunity to demonstrate the broad efficacy of our unique product candidate and to play a leadership role in advancing the science and clinical practice of treating pneumonia."

Continued Dr. Flavin: "Using clinical response in the MRSP population as the primary endpoint provides the most scientifically meaningful approach to demonstrate a clinical efficacy advantage against resistant strains of Streptococcus pneumonia. Importantly, this approach will provide Advanced Life Sciences a viable path to move Restanza towards approval and commercialization."

SOURCE Advanced Life Sciences Holdings, Inc.