Aspreva Completes Expanded Patient Enrollment In Phase III Clinical Trialfor CellCept In Pemphigus Vulgaris
06/04/07
Aspreva Pharmaceuticals
Corporation (NASDAQ: ASPV; TSX: ASV) today announced successful completion
of patient enrollment in their global phase III clinical trial designed to
assess the safety and efficacy of CellCept(R) (mycophenolate mofetil) in
association with corticosteroids to achieve remission in patients with
active pemphigus vulgaris.
The total number of patients enrolled in this pemphigus vulgaris study
is 96. Today's announcement represents a new patient total for this trial
following the re-opening of patient recruitment in late 2006 as a result of
a protocol amendment requested by the US Food & Drug Administration to
increase the statistical power of the study.
Dr. Usman Azam, Aspreva's Chief Medical Officer, said: "By
strengthening the statistical power of this study, we have improved our
ability to assess the potential efficacy of mycophenolate mofetil in the
treatment of this complicated and rare disease. Ultimately our goal is to
add to the pool of evidence-based treatment options for patients with less
common diseases and this study is another step towards that goal."
This randomized, double-blind, placebo-controlled comparison study is
designed to investigate the efficacy and safety of mycophenolate mofetil in
patients with active pemphigus vulgaris over a treatment period of 52
weeks. The primary end-point encompasses both minimal disease activity,
defined as no new persistent lesions, with a low steroid dose. Aspreva
expects to complete the study in 2008.
About Pemphigus Vulgaris
Pemphigus Vulgaris is a rare, severe, and chronic autoimmune disease
that causes blisters of the skin and mucous membranes. According to the
International Pemphigus Foundation, the disease affects approximately
40,000 people worldwide. People suffering from this disease develop fragile
skin blisters which may burst, leaving raw, crusted areas, which may cover
large areas of the body's surface. Pemphigus vulgaris often begins with
oral lesions, which may become painful, leaving patients unable to eat or
drink, which may lead to malnutrition and debilitation.
About CellCept
CellCept is Roche's leading immunosuppressant or "anti-rejection" drug.
It is 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. This therapeutic success in the prevention of organ
rejection in adult kidney, heart and liver transplantation represents 11
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.
In July 2003, Aspreva signed a collaboration agreement with Roche for
the exclusive worldwide rights (excluding Japan) to develop and, upon
regulatory approval, commercialize CellCept for all autoimmune disease
applications.
It is important to note that CellCept has not been approved by the FDA
for the treatment of any autoimmune disease, including pemphigus vulgaris.
About Aspreva Pharmaceuticals
Aspreva is a global pharmaceutical company focused on identifying,
developing, and, upon approval, commercializing evidence-based medicines
for patients living with less common diseases. Aspreva common stock is
traded on the NASDAQ Global Select Market under the trading symbol "ASPV"
and on the Toronto Stock Exchange under the trading symbol "ASV". Learn
more at
(Author: http://www.aspreva.com)
| << Prev | Pharmacy News Home | Next>> |
|---|
