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AlphaRx Inc. (OTC Bulletin Board: ALRX) and Proprius Pharmaceuticals, Inc.
today announced top line results from the Indaflex(TM) 2.5% Topical
Indomethacin Cream exploratory phase II clinical trial in osteoarthritis
(OA) of the knee (INDF-200). The proof of concept study was initiated in
September 2005 by AlphaRx, and was performed in Canada.
The randomized double-blind placebo and vehicle controlled trial, which
included a six week treatment period, was conducted in 233 patients with OA
of the knee. The primary endpoints used in the trial were the change from
baseline to week six in the global Western Ontario and McMaster
Universities Osteoarthritis Index (WOMAC) score and the subject's global
assessment of efficacy. While the trial did not meet its primary endpoints,
subgroup analyses of patients with moderate to severe pain and more
impaired physical function at baseline showed positive trends in patients
treated with Indaflex(TM) as compared to patients treated with either
placebo or vehicle. Indaflex(TM) was demonstrated to be safe and well
"We are encouraged by the results of this first human efficacy trial
comparing Indaflex(TM) to both placebo and vehicle," said Michael J. Walsh,
President & CEO of Proprius Pharmaceuticals. "The data point to the promise
of Indaflex(TM) as a very well tolerated and safe topical NSAID product
candidate, with potential for efficacy in treating moderate to severe pain
and improving function for patients suffering from osteoarthritis of the
knee. The knowledge gained from this proof of concept study has provided
important insights on appropriate pivotal trial design. We are eager to
discuss our findings with the Food and Drug Administration, and advance
Indaflex into registration trials."
Dr. Lee S. Simon, a Rheumatologist and former Director of the Food and
Drug Administration's Analgesic, Anti-Inflammatory and Ophthalmic Drug
Products Division, and a consultant to the companies, commented, "The
results of this initial clinical trial provide supportive evidence for the
efficacy and safety of Indaflex(TM). This therapeutic product candidate has
the potential to fulfill the need for an effective, tolerable and safer
alternative to either oral non-selective NSAIDs or COX-2 selective
inhibitors for the treatment of osteoarthritis of the knee, as well as
other diseases and disorders which are associated with localized pain and
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.
Indaflex(TM) is a topical NSAID (Non-Steroidal Anti-Inflammatory Drug)
formulation in clinical development for the reduction of signs and symptoms
associated with OA of the knee. Arthritis is the most common chronic
disease in North America and afflicts an estimated 10% of the world's
population. The active ingredient in Indaflex(TM), indomethacin, has a
long-standing and proven clinical treatment record. Delivered through the
skin using a proprietary nanoparticle technology developed by AlphaRx, the
companies believe Indaflex(TM) will have an attractive efficacy, safety and
tolerability profile in comparison to oral treatments and other topical
preparations. Proprius Pharmaceuticals acquired the exclusive global rights
to Indaflex(TM) (with the exception of Asia and Mexico) in April 2006.
About Proprius Pharmaceuticals, Inc.
Proprius Pharmaceuticals is a specialty pharmaceutical company that
develops and markets personalized medicine solutions in rheumatology and
autoimmune diseases. This novel combination of proprietary pharmaceuticals
and diagnostic services provides a strategic and differentiated approach to
commercialization. Proprius is a privately-held, venture-backed company.
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.
For more information, please click here
Proprius Pharmaceuticals, Inc.
12264 El Camino Real, Suite 350
San Diego, CA 92130-3062
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