June 27, 2008
AlphaRx’s Pneumonia Drug Improves Survival in Preclinical Studies
AlphaRx has reported additional pre-clinical data on Zysolin, an inhaled Tobramycin nanoparticle intended for the adjunctive treatment of Pseudomonas aeruginosa pneumonia in intubated and mechanically-ventilated patients.
Injectible Tobramycin is used in the initial empirical therapy for mechanically-ventilated patients (VAP) and is also well known for its nephrotoxicity.
AlphaRx's Zysolin is intended to replace injectible Tobramycin in VAP therapy. AlphaRx believes Zysolin will have safety, tolerability and efficacy profile in comparison to injectible Tobramycin.
Zysolin has demonstrated superior therapeutic efficacy in two pivotal animal studies. In these lethality-based studies, Zysolin has consistently increased survival rate by 50% over Tobramycin treatment group whereby all mice in the untreated group died within 24 hours after infection.
AlphaRx is working with regulatory experts to devise a clinical plan for Zysolin with a view to initiating Phase I human trials in early 2009. AlphaRx believes Zysolin may be eligible for a new drug application (NDA) submission under the 505(b)(2) regulatory pathway, which permits companies to obtain FDA approval of new drug applications (NDAs) by relying, in part, on the agency's findings for a previously approved drug.