AlphaRx Announces Completion of Phase II Clinical Trial for Indaflex
- Category: Small Molecules
- Published on Tuesday, 06 March 2007 02:00
- Hits: 2351
MARKHAM, Canada | Mar 05, 2007 | AlphaRx (OTCBB:ALRX) announced today the completion of the treatment phase of the double-blind, placebo & vehicle-controlled, randomized and multi-center Phase II clinical trial, to measure the efficacy and safety of Indaflex(tm) for the treatment of Osteoarthritis of the knee. Currently, no prescription strength topical NSAID for the treatment of arthritis is approved for sale in the U.S.
Following data validation and analysis, the Company expects to report top-line trial results by the end of March 2007.
In April 2006, AlphaRx licensed Indaflex to Proprius Pharmaceuticals, Inc. Under the terms of the agreement, AlphaRx is eligible to receive milestone payments of up to $116 million for the successful development and commercialization of Indaflex, as well as double-digit royalties on worldwide sales. In addition, Proprius has assumed all clinical development costs.
Indaflex is AlphaRx's topical NSAID (Non-Steroidal Anti-inflammatory Drug) formulation under clinical development for the treatment of arthritis symptoms. Osteoarthritis is the most common chronic disease in North America and afflicts an estimated 10% of the world's population. Indaflex's active ingredient, Indomethacin, has a long-standing and proven clinical treatment record. 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 commonly found with orally ingested NSAID's.
About AlphaRx Inc.
AlphaRx is a clinical stage pharmaceutical 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. The Company's product candidates address various pharmaceutical markets, including arthritis, tuberculosis, ocular infection and inflammation, pneumonia and sepsis.
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.