Advanced Life Sciences submits proposal for IV Restanza formulation

Advanced Life Sciences Holdings, Inc. has submitted a full proposal to the National Institute of Allergy and Infectious Diseases to develop an intravenous formulation of Restanza to counteract bacterial pneumonia, plague, anthrax and tularemia.

The company anticipates that it will receive one or more awards from the solicitation on or around July 29, 2011. The proposal requests $38 million over the course of five years to develop the IV formulation to therapeutically treat these potential biological pathogens.

The funding would include pre-clinical development of IV Restanza and Phase 1 and 2 clinical trials to evaluate safety and efficacy of the drug with patients hospitalized with bacterial pneumonia.

“We are pleased to have submitted a full proposal to NIAID which, if awarded, could significantly advanced the development of intravenous formulation of Restanza for the therapeutic treatment of bioterror pathogens as well as for the commercial indication of community acquired bacterial pneumonia,” Michael T. Flavin, CEO of Advanced Life Sciences, said, “In addition to the efficacy demonstrated by the oral form of Restanza for post-exposure prophylaxis of anthrax, plague and tularemia, the oral form of Restanza has shown initial efficacy in treating anthrax infection where symptoms are present. This is significant because there are currently no agents approved by the FDA for the therapeutic treatment of anthrax, plague or tularemia.”

Results from a GLP study showed that the IV formulation of Restanza was tolerated well and it generated a 10-fold higher plasma exposure to the drug than oral administration.