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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.
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Act of 1995. These include without
limitation statements related to our clinical trials, product candidates and
operations. Words such as "anticipates," "believes," "estimates," "expects,"
"intends," "may," "plans," "projects," "will," "would" and similar expressions
are intended to identify forward-looking statements, although not all forward-
looking statements contain these identifying words. These forward-looking
statements are based upon our current expectations and we may not actually
achieve the plans, intentions or expectations disclosed in our forward-looking
statements. Forward-looking statements involve risks and uncertainties. Our
actual results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to the
progress, timing and results of our clinical trials, our ability to attract
and retain collaborations relating to the development and commercialization of
new indications, intellectual property matters, difficulties or delays in
obtaining regulatory approval, competition from other pharmaceutical or
biotechnology companies, and other risks detailed in our filings with the
Securities and Exchange Commission and Canadian securities regulatory
authorities. You are cautioned not to place undue reliance on these forward-
looking statements, which speak only as of the date of this press release. All
forward-looking statements are qualified in their entirety by this cautionary
statement, and Aspreva undertakes no obligation to revise or update any
forward-looking statements as a result of new information, future events or
otherwise after the date hereof.
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