MARKHAM, ON and SAN DIEGO, CA -- Dec 11, 2006 -- AlphaRx Inc. (OTC BB:ALRX.OB) and Proprius Pharmaceut
icals, Inc. today announced that 210 patients have now been enrolled in the Indaflex(T
M) Phase II osteoarthr
itis (OA) clinical trial being conducted in Canada. The companies anticipate that the trial will be completed and results will be announced in the first half of 2007.
Michael Lee, President & CEO of AlphaRx, commented, "We are very pleased to see the trial progress through the accomplish
ment of this significan
t milestone, and look forward to announcing the results in the coming year."
Michael J. Walsh, President & CEO of Proprius Pharmaceut
icals, stated, "Indaflex(
TM) has great potential as an alternativ
e for addressing local joint pain in this chronic and debilitati
ng condition affecting some 25-30 million Americans. Our continued interactio
ns with experts in osteoarthr
itis and pain management reinforce this belief, and underscore the significan
t level of interest from U.S. physicians in having access to a highly effective, safe and tolerable topical NSAID."
"With the achievemen
t of our enrollment objective for this Phase II study of Indaflex(T
M) for OA of the knee, we look forward to a successful completion of the trial," remarked David W. Anderson, Ph.D., Chief Scientific Officer for Proprius Pharmaceut
icals. "We are on track to file an Investigat
ional New Drug applicatio
n with the U.S. Food and Drug Administra
tion in the coming months and advance Indaflex(T
M) into pivotal safety and efficacy trials in 2007."
In April 2006, AlphaRx licensed Indaflex(T
M) to Proprius Pharmaceut
icals, Inc. Under the terms of the agreement, AlphaRx is eligible to receive milestone payments of up to $116 million for the successful developmen
t and commercial
ization of Indaflex(T
M), as well as double-dig
it royalties on worldwide sales. In addition, Proprius has assumed all clinical developmen
t costs.
About Indaflex(TM) Indaflex(T
M) is a topical NSAID (Non-Stero
idal Anti-infla
mmatory Drug) formulatio
n currently in Phase II clinical developmen
t 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(T
M), indomethac
in, has a long-stand
ing and proven clinical treatment record. Delivered through the skin using proprietar
y technology developed by AlphaRx, the companies believe Indaflex(T
M) will have an attractive safety, tolerabili
ty and efficacy profile in comparison to oral treatments and other topical preparatio
ns.
About AlphaRx Inc. AlphaRx is a clinical stage biopharmac
eutical company utilizing proprietar
y drug delivery technology to develop novel formulatio
ns of drugs that are insoluble or poorly soluble in water or have yet to be administra
ble to the human body with an acceptable delivery method. The Company's product candidates address various pharmaceut
ical markets, including arthritis, tuberculos
is, ocular infection and inflammati
on, cataracts, hospital acquired pneumonia and sepsis.
About Proprius Pharmaceuticals, Inc.
Proprius Pharmaceuticals is a fully-integrated specialty pharmaceutical company that develops and markets personalized medicine solutions in rheumatology and autoimmune diseases. This novel combination of proprietary therapeutics and diagnostic services provides a strategic and differentiated approach to commercialization. Proprius is a privately held and venture-backed organization, with financing provided by Fog City Fund, and Windamere Venture Partners, LLC.
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.
Contact:
For more information, please contact:
For AlphaRx Inc.:
AGORACOM Investor Relations Corp.
Web: http://www.agoracom.com
E-mail: Email Contact
For Proprius Pharmaceuticals, Inc.:
Michael J. Walsh, President & CEO
Web: http://www.propriuspharma.com
Email: Email Contact
