Zysolin(TM) Pre-clinical Data Supports Once-a-day Dosing In Humans

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 19 Jun 2009 - 3:00 PDT

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AlphaRx (OTC BB:ALRX) is pleased to report a significant breakthrough in the development of Zysolin(TM), an inhaled Tobramycin nanoparticle formulation utilizing the company's proprietary drug delivery platform, and intended for the adjunctive treatment of Pseudomonas Aeruginosa Pneumonia in intubated and mechanically-ventilated patients (VAP).

In a recent pivotal animal PK (pharmacokinetic) study, Zysolin(TM) delivered 300% more drug to lung tissue than free drug, when utilizing the same delivery method. This data demonstrates that Zysolin(TM) provides superior lung tissue penetration and a release profile which supports once-a-day human dosing frequency.

The study data will be presented, by invitation, to the upcoming July meeting of the Controlled Release Society Conference in Copenhagen, Denmark.

Dr. Michael Weisspapir, MD, PhD, Chief Medical Scientist of AlphaRx commented, "As a result of this pre-clinical data, we anticipate that the demonstrated superiority over free drug availability will result in higher drug concentrations in lung tissue, enhancing clinical efficacy for VAP patients in vivo."

About Zysolin(TM)

Zysolin(TM) is a Tobramycin compound, encapsulated in AlphaRx's Nano Drug Delivery Platform, intended for the adjunctive treatment of Gram-negative pneumonia in intubated and mechanically-ventilated patients. Zysolin(TM) improves the intracellular activity of Tobramycin - in layman's term, increasing the drug concentration of Tobramycin inside human macrophages, thus improving its antibacterial activity against intracellular Klebsiella, Pseudomondas aeruginosa and Staphylococcus bacterial strains in pneumonia patients. The active ingredient in Zysolin(TM), Tobramycin, has a long-standing and proven clinical treatment record. Delivered by inhalation, using proprietary nanotechnology developed by AlphaRx, the company believes Zysolin(TM) will have an attractive safety, tolerability and efficacy profile when compared to injectible Tobramycin.

About AlphaRx Inc.

AlphaRx is a specialty pharmaceutical company dedicated to developing proven therapies by reformulating FDA approved and marketed drugs which through the application of its proprietary site-specific nano drug delivery technology, offers improved medical benefits and a potential for significant commercial product development.

Forward Looking Statements:

This release contains forward-looking statements within the meaning and pursuant to the Safe Harbor provisions of the Securities Litigation Reform Act of 1995 and involve risks and uncertainties that may individually or mutually impact the matters herein described, including but not limited to product development and acceptance, manufacturing, competition, regulatory and/or other factors, which are outside the control of the companies.

Source: AlphaRx Inc