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AlphaRx to Begin Phase 1 Clinical Trial with Lead Pharmaceutical Product Indaflex(TM)

2005-02-16 08:02 ET - News Release


MARKHAM, ON, Feb. 16 /PRNewswire-FirstCall/ -- 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 AlphaRx has received approval from the appropriate authorities to begin Phase 1 human trial for its lead pharmaceutical product Indaflex(TM).

The primary objective of this study is to evaluate the safety and tolerability of single- and multiple-dose applications of Indaflex(TM), a novel formulation of indomethacin cream. The secondary objective of this study is to evaluate the bioavailability of Indaflex(TM) relative to Indomethacin 50 mg capsule, after a single-dose in healthy subjects.

About Indaflex

Indaflex is AlphaRx's topical NSAID (Non-Steroidal Anti-inflammatory Drug) formulation intended to start clinical development soon for use in the treatment symptoms of arthritis. Arthritis is the most common chronic condition in North America and afflicts an estimated 10% of the world's population. Indaflex's active ingredient, Indomethacin, has long-standing and proven clinical treatment records. With AlphaRx's enhanced proprietary delivery system, the company believes its clinical effectiveness will be significantly enhanced compared to other topical preparations. Topical Indaflex delivery, the company hopes may circumvent the significant GI side-effects found with orally ingested NSAID's.

About AlphaRx Inc. (http://www.alpharx.com/)

AlphaRx is an emerging biopharmaceutical company utilizing proprietary drug delivery technology to develop novel formulations of drugs that are insoluble or poorly soluble in water or have yet to be administrable to the human body with an acceptable delivery method.

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.

For more information, please contact:

Agora Investor Relations Corp.
Web: http://www.agoracom.com/
E-mail: [e-mail]
AlphaRx Inc.



CONTACT: Agora Investor Relations Corp., Web: http://www.agoracom.com/,
E-mail: [e-mail]