ALRX News - AlphaRX Announces Data and Comparative Results on ARX2002
Richmond Hill, Ontario - September 09, 2002 - AlphaRx Inc. (ALRX: OTCBB) is pleased to announce recently compiled data and results on ARX2002, an orally and parenterally active non-steroidal compound, which demonstrates anti-inflammation activity at least twenty times greater than a well-known non-steroidal anti-inflammatory drug. The data was compiled under the direction of Principal Investigator Dr. Peter Carlen at the Toronto Western Hospital of the University Health Network (UHN). ARX2002 and AlphaRx's other lead compound, ARX2001, are being tested in more advanced neuroprotective models such as encephalomyelitis, in vitro ischemia and neurotrauma to further validate their clinical use in the treatment and prophylaxis of ischemia-reperfusion damage in stroke and head trauma.
Anti-inflammatory activity was investigated in the laboratory using a Carrageenan non-infective inflammation model to compare the effectiveness of ARX2002 to Indomethacin* (2 mg/kg of Indomethacin vs. 0.1 mg/kg of ARX2002, IP injection). The data demonstrated a significantly greater suppression of Carrageenan induced inflammation with ARX2002, with anti-inflammatory activity being comparable to steroidal compounds, such as Dexamethasone.
*Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that relieves the inflammation and pain associated with rheumatoid arthritis (rheumatism), osteoarthritis, ankylosing spondylitis, and gout.
"We believe the anti-inflammatory activity of ARX2002 is significantly higher than Indomethacin and as effective as Dexamethasone (a steroidal drug) but without the side effects associated with either of these drugs, " stated CEO, Mr. Michael Lee.
NSAIDs are frequently associated with significant adverse gastrointestinal (GI) side effects such as stomach ulcers and internal bleeding in patients using these compounds. Steroidal drugs also seriously compromise the human immune system. These side effects are a major concern and limit or prohibit their use by many patients. The US market for non-steroidal anti-inflammatory drugs (NSAID) in 2002/2003 is estimated to be $US 3 billion (excluding drugs sold for arthritic conditions).
This study, conducted by Dr. Carlen, tested the new compound orally and by injection, in a Carrageenan-induced inflammation model, using Indomethacin as a positive control. The dosages used were as follows: Indomethacin and ARX2002 0.1 mg/kg by IP injection, and ARX2002 1.0mg/kg orally. Inflammation reached peak levels after 3 hours with ARX2002 providing approx. 80% suppression of inflammation by oral administration and 75% suppression via injection, compared to 45% suppression by the Indomethacin control.
AlphaRx's lead compounds have also shown significant immune system modulating properties, low toxicity, fast onset and prominent anti-inflammatory activity in pre-clinical studies previously conducted by the Company. Successfully developed, they offer great potential for the future of immunomodulation therapy, suitable for the treatment of immune deficiency states which include cancer, AIDS, Alzheimer's disease, multiple sclerosis and severe acute and chronic inflammatory conditions such as arthritis and colitis.
About UHN
University Health Network is a major landmark in Canada's health care system and a teaching centre of the University of Toronto. Building on the strengths and reputation of each of three remarkable hospitals, Toronto Western Hospital, Toronto General Hospital, and Princess Margaret Hospital, the organization brings together the talent and resources which make it an international leader in health care.
Dr. Carlen, Principal Investigator is a senior scientist with the Toronto Western Research Institute, neurologist with the Krembil Neuroscience Centre at the Toronto Western Hospital, and professor of medicine (neurology) at the University Of Toronto.
About AlphaRx
AlphaRx is engaged in the development of novel formulations of drugs that are insoluble or poorly soluble in water. AlphaRx's broad product pipeline consists of carefully selected, currently marketed drugs, which, through the application of its proprietary drug delivery technology, offer improved medical benefits over existing products with a strong commercial potential.
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.
Note: The FDA has not evaluated these statements. This statement is not intended to diagnose, treat, cure of prevent disease.
Contacts:
AlphaRx <http://www.alpharx.com>
Brad Caister
Tel: 905-762-0745 Ext. 238
Econ Investor Relations Toll free: 888-368-8705
Dawn Van Zant Email: dvanzant@investorideas.com <mailto:dvanzant@investorideas.com>
