I think it's not a standard treatment in UK or Canada until the trial
results are out or unless by special dispensation or if it's fast tracked
due to astonishing results (compared to other protocols).
Let's see what Shelagh, BJ, Andy or Herb say about that.
J

http://www.canada.com/health/story.html?id=c15e62e6-1851-4c69-bcf2-01d9e927f358

Published: Thursday, November 24, 2005
(AP) - Doctors are reporting the first advance in three decades in
treating kidney complications from lupus, a life-threatening disease that
primarily affects young women.

A small study showed that an immune-suppression drug worked better than
the standard chemotherapy medication, which can cause infertility and
other problems.

Nearly a quarter of patients who took the newer drug, CellCept, saw their
kidney problems go into complete remission after six months, compared with
just six per cent of those who received the older treatment,
cyclophosphamide. The CellCept patients also had fewer side effects.

"This holds great promise for a better quality of life for people with
lupus," said Sandra Raymond, president of the Lupus Foundation of America.

The study was led by Dr. Ellen Ginzler of the SUNY Downstate Medical
Center in New York and published in Thursday's New England Journal of
Medicine. Partial results were presented in 2003 at a scientific
conference in Orlando, Fla.

Lupus is a crippling and sometimes fatal disease that mostly strikes women
of childbearing age. About 1.5 million Americans have the disorder, in
which the body's immune system attack its own organs and tissue. No one
knows why it happens. One third of all lupus patients suffer from
inflammation of the kidney that can lead to kidney failure.

For the past 30 years, chemotherapy has been the standard treatment for
the kidney complications. But the side effects can include hair loss,
nausea and infertility - problems that can lead patients to skip their
chemo.

CellCept, made by Hoffmann-La Roche Inc., is approved by the Food and Drug
Administration to prevent organ rejection in transplant patients. But some
doctors prescribe it to lupus patients who cannot tolerate chemotherapy.

In the study, 140 people received either daily oral doses of CellCept or
monthly intravenous doses of cyclophosphamide.

After six months, 23 per cent of those who took CellCept had complete
remission. An additional 30 per cent in the CellCept group had partial
remission, versus 25 per cent of those in the chemotherapy group.

Patients who took CellCept also had fewer infections and hospitalizations
but experienced more diarrhea.

The study was supported by grants from the FDA and Roche Laboratories.

In an accompanying editorial, Dr. W. Joseph McCune of the University of
Michigan Medical Center wrote that CellCept will not become the standard
of care until a larger, more definitive study is done. But he said it is
reasonable for doctors to prescribe the drug to patients worried about
preserving fertility.

A larger international study sponsored by a Canadian pharmaceutical
company is under way, comparing the long-term effects of CellCept and
chemotherapy in lupus patients.
© The Canadian Press 2005

http://www.uklupus.co.uk/news79.html
Vancouver, BC, July 28, 2005--(T-Net)--Aspreva Pharmaceuticals Corporation
announced that patient dosing has begun in the pivotal phase III clinical
study evaluating CellCept for the treatment of lupus nephritis. In October
2003, Roche and Aspreva entered into a unique collaboration for Aspreva to
further develop Roche's leading transplant product, CellCept, in
autoimmune diseases.

Aspreva's phase III Lupus Management Study will be one of the largest
Phase III studies conducted in lupus nephritis. The study aims to enrol
358 patients with biopsy proven lupus nephritis in over 100 centres
worldwide.

Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic
autoimmune disease that causes the body to attack its own tissues and
joints. Lupus nephritis is the most serious manifestation of this disease
which left untreated, can lead to kidney failure, requiring dialysis. It
is a complicated disease as patients typically fluctuate between periods
of intense disease activity when the patient's own immune system is
actively attacking and causing damage in their kidney, interspersed with
periods of remission.

The two-phase induction to maintenance study is a randomized open label
comparison of CellCept with the current standard of care cyclophosphamide
for the first six months, followed by a double-blind comparison of
CellCept to azathioprine for up to three years. This study will assess the
efficacy and safety of CellCept in inducing and maintaining remission in
patients with lupus nephritis. Results from the first phase of the study
are expected in late 2006, submission of a regulatory filing is expected
in mid to late 2007.

"Our goal is to develop a new treatment option for patients with lupus
nephritis; it has been over 30 years since these patients have had hope
for a new treatment with better efficacy and fewer side effects compared
with the current standard of care. This is the third and largest phase III
pivotal program Aspreva has initiated for autoimmune indications over the
past 15 months and is a testament to the tremendous collective effort of
the Roche and Aspreva collaboration," said Richard M. Glickman, Aspreva's
Chairman and Chief Executive Officer.

"This study marks an important milestone in this innovative partnership
with Aspreva. It demonstrates our collective success in developing
globally supported clinical programs for CellCept for complex autoimmune
diseases," said Peter Hug, Global Head of Roche Pharma Partnering.
"Together we are working to extend the use of our leading transplant
medicine to meet the needs of underserved patients."

About Lupus

Systemic lupus erythematosus (SLE), commonly referred to as lupus, is a
complex autoimmune disease affecting numerous organs and tissues. The
immune system, which typically fights off viruses and bacteria, loses the
ability to differentiate between foreign substances (antigens) and its own
cells and tissues. The involvement of the kidney, known as lupus
nephritis, is considered to be the most serious manifestation of SLE.

There has been no new approved treatment for SLE or lupus nephritis in the
United States in the last thirty years. Current treatments involve the
off-label use of existing cancer drugs such as cyclophosphamide, steroids,
and other immunosuppressant drugs such as azathioprine.

About CellCept

CellCept is an immunosuppressant or "anti-rejection" drug used in
combination with other immunosuppressive drugs (cyclosporine and
corticosteroids) for the prevention of rejection in patients receiving
heart, kidney and liver transplants. CellCept was first approved for use
in combination therapy for the prevention of acute organ rejection in
kidney transplantation in 1995 and has since been approved worldwide for
prevention of organ rejection in adult kidney, heart and liver
transplantation. In some countries, it is also approved for paediatric
kidney transplantation. This therapeutic success represents 10 years of
clinical experience and patient benefits, including reduced toxicities and
prolonged graft and patient survival. Over the last decade, CellCept has
become the world's most widely studied immunosuppressant and research is
ongoing both in organ transplantation and related areas, such as
autoimmune disease, to help provide clinical benefit to a wider range of
patients.

CellCept is not currently approved for the treatment of either lupus
erythematosus or lupus nephritis.

About Aspreva Pharmaceuticals

Aspreva Pharmaceuticals is an emerging pharmaceutical company focused on
identifying, developing and commercializing new indications for approved
drugs and drug candidates for underserved patient populations. Aspreva's
"indication partnering" strategy allows its partners to maintain core
brand focus while extending the benefits of their medicines to a broader
patient population.

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of the Private Securities Litigation Act of 1995. These include without
limitation statements related to our clinical trials, product candidates
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