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AlphaRx Inc. (OTC BB:ALRX.OB - News), an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs, is pleased to announce that it has completed the lyophilization process for Zysolin(TM), allowing the company to proceed to clinical batch material manufacturing for human trials. This process has been solely developed by AlphaRx's scientists and the resulting formulations have been successfully tested in animal studies conducted by the U.S. Army under a Material Transfer Agreement.
"This is a technological milestone for AlphaRx and the entire nanomedicine industry," commented Dr. Joseph Schwarz, AlphaRx's Chief Scientist. "It is well known that many FDA approved ingredients used in nanomedicine formulations can not be readily lyophilized, representing the major obstacle to their therapeutic development, a critical step which we have overcome."
Many biotechnology products require lyophilization, a process of freeze-drying sterile solutions to permit a shelf stable dosage form. By removing the water from the material and sealing the material in a vial, it can be easily stored, shipped, and later reconstituted to its original form for administration.
Zysolin(TM) is protected by 3 U.S. patents pending and the Company plans to file a new patent application to protect this new process.
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 Company.
This press release is available on the company's official on-line investor relations site for investor commentary, feedback and questions.
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