University of Hong Kong Clinical Study Confirms Efficacy of Lyprinol in Treating Osteoarthritis.

Business Editors/Health/Medical Writers

LOS ANGELES--(BUSINESS WIRE)--March 4, 2004

The first double-blind placebo-controlled clinical trial of Lyprinol(R) in patients with Osteoarthritis (OA) confirms its effectiveness in the treatment of pain and in increased mobility in patients suffering from OA and other chronic inflammatory diseases. Professor C.S. Lau, co-chief; Division of Rheumatology, the Dept. of Medicine of the University of Hong Kong, facilitated the study. The results could have a significant impact on the American populace as the Arthritis Foundation has found that OA affects nearly 21 million Americans with medical costs estimated from $15.5 billion to $28.6 billion annually.

This latest clinical trial validates the findings of over 25 years of pioneering Australian research regarding Lyprinol(R). Lyprinol(R) is a marine lipid extract derived from the Perna canaliculus or the New Zealand Green-Lipped Mussel. The extract's composition is a combination of polyunsaturated fatty acids that has been investigated by leading Australian research institutes including The Royal Melbourne Institute of Technology, The Queen Elizabeth Hospital in Adelaide and the University of Queensland and has been found to have unique anti-inflammatory activity.

The clinical trial was conducted from 2001-2003 at the Queen Mary Hospital of the University of Hong Kong. Eighty patients with knee OA were randomized to receive either Lyprinol(R) or placebo for six months. All were allowed paracetamol/acetaminophen rescue treatment during the study and were reviewed at week 0, 2, 4, 8, 12, 18 and 24 for arthritis assessment and safety evaluation. Assessment of the patients' arthritis included the use of a 100 mm visual analog scale (VAS) for pain, patient's and physician's global assessment of arthritis, a validated Chinese version of the Oxford Knee Score (COKS), a validated Chine version of the Arthritis Impact Measurement Scale 2-short form (CAIMS2-SF), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).

Clinical Trial Results

There was a greater improvement in the perception of pain as measured by the VAS. Patients' global assessment of arthritis in those who took Lyprinol(R) when compared with controls from week four following adjustment for the change in the amount of paracetamol/acetaminophen used between study visits. Patients who took Lyprinol(R) but not placebo also had improved scores in the CAIMS2-SF physical function and psychological status domains from week four.

When used over six months, Lyprinol(R) was safe and well tolerated with no serious side effects reported. Further, there were no significant differences in the overall incidence of adverse reactions or withdrawal from study as a result of trial drug toxicity between Lyprinol(R)- and placebo-treated patients.

Professor Lau concludes that Lyprinol(R), may be considered a safe option in the treatment of OA. The clinical trial findings will be published in the first 2004 issue of the journal Progress in Nutrition (Mattioli 1885 Publ.).

Further clinical trials of Lyprinol(R) have already been started for moderate to severe asthma and a psoriasis trial will be conducted in the year 2004 in one of Australia's leading clinics.

For further information regarding Lyprinol(R), visit www.lyprinolusa.com