The Disease Modifying Effect of Chondroitin Sulphate in Patients With Knee Osteoarthritis has Been Confirmed by MRI

A Clinical Trial by Prof. Jean-Pierre Pelletier has Been Published in Annals of the Rheumatic Diseases (1)

BARCELONA, March 7, 2011 - A group of Canadian researchers led by Prof. Jean-Pierre
Pelletier, Head of the Osteoarthritis Research Unit, at the University of
Montreal Hospital Research Centre, published a clinical trial, in which they
confirm, for the first time using quantitative Magnetic Resonance Imaging
(qMRI), the disease modifying effects of chondroitin sulphate, a symptomatic
slow acting drug for osteoarthritis (SYSADOA).

This clinical trial, published in Annals of the Rheumatic
Diseases (impact factor 8.111), explored the effect of chondroitin sulphate
(CS) treatment on cartilage volume loss, subchondral bone marrow lesions
(BML) and synovitis in patients with knee osteoarthritis (OA). "This study
focused on quantifying over time by MRI the main structural changes observed
in the cartilage, bone and synovial membrane", Prof. Pelletier said.

The investigator states that after only six months of
treatment with CS, patients show a significant decrease in loss of articular
cartilage as compared to the placebo group, and for the first time, a
significant reduction in the progression of BMLs by 12 months.

According to Prof. Pelletier, these data highlight not only
the importance of the interrelationship between cartilage and subchondral
bone in OA, but also its potential role in the disease process and response
to treatment with SYSADOAs.

Prof. Pelletier concluded that, "CS is a safe drug with an
overall positive effect on OA, significantly reducing the volume of cartilage
loss in knee OA, and providing for the first time new information on its
positive effect in vivo on other structural changes observed in this
disease."

Professor Pelletier commented that the clinical trial results
prove that CS is able to slow the progression of OA, however this does not
mean it is able to cure. "The cure involves the regression of all lesions
related to OA, " he says, "and that's not the case. Chondroitin sulphate
slows the progression of the disease. This is an important finding as a
decrease in the rate of progression of cartilage loss in knee OA patients, as
seen by MRI, could potentially reduce the need for total knee replacement - a
phenomenon that has been observed in other MRI clinical studies."

Confirming Previous Studies

The clinical trial by Prof. Pelletier definitively supports
the findings of previous studies describing the positive effects of CS on the
pathogenic mechanisms of action of OA (Kwan S et al 2007; Monfort J et al
2005; Bassleer et al 1998; Ronca de 1998, etc), and supports the ability of
CS to modify the natural history of the disease, as previously demonstrated
by Kahan (2009), Michel (2005), and Uebelhart (1998 and 2004), and the two
meta-analyses by Hochberg (2008 and 2010).

Similarly, Prof. Pelletier said that these findings refute the
conclusions reached by S. Wandel et al. in a meta-analysis published in the
British Medical Journal (BMJ) in 2010 to the effect that SYSADOAs do not
offer benefits in the treatment of patients with OA.

In this regard, Prof. Pelletier says, "the methodology used by
Wandel et al. is questionable based on the opinion of several experts in the
field of OA, as reflected by the several letters to the editor posted on the
BMJ website, some of which have also been published in the official Journal.
The results of the Wandel et al. meta-analysis are in contrast to many other
meta-analyses performed by expert scientists dealing with the same issue,
which have shown that CS is an effective symptomatic treatment for OA and
that it can slow disease progression."

"In line with my previous comments, following the publication
of this meta-analysis, one of the editors from BMJ issued an official
statement in the BMJ website questioning some of the assumptions made in the
article and also mentioning a possible conflict of interest of the BMJ senior
statistics editor, thus seriously questioning the validity and reliability of
this meta-analysis," Prof. Pelletier specified.

Future goals

The expert says the results of this pilot MRI study are very
positive and encouraging. Given the evidenced efficacy and safety of the
product, it definitely represents a most valuable option for OA patients.
Though he notes, "it is important that patients are provided with highly
purified pharmaceutical grade CS, the one used in this study, as this is the
only one that can guarantee such efficacy and specially, safety results."

Jean -Pierre Pelletier, MD, Professor of Medicine, Head - Arthritis
Division, Director of Osteoarthritis Research Unit, University of Montreal
Hospital Research Centre (CRCHUM)

(1) Wildi LM, Raynauld JP, Martel-Pelletier J. et al. Chondroitin
sulphate reduces both cartilage volume loss and bone marrow lesions in knee
osteoarthritis patients starting as early as 6 months after initiation of
therapy: a randomised, double-blind, placebo-controlled pilot study using
MRI. Ann Rheum Dis ,March 2011; 10.1136/ard.2010.140848. Epub

For interview requests or further information please contact: Marta Patllé. Ogilvy Comunicación., Tel: +34-93-495-55-87 - +34-607-409-778, marta.patlle at ogilvy.com