VICTORIA, Nov. 25 /PRNewswire-FirstCall/ -- Aspreva Pharmaceuticals Corporation (NASDAQ: ASPV; TSX: ASV), today reported that the results of Dr. Ellen M. Ginzler's investigator initiated trial (IIT) comparing orally administered mycophenolate mofetil (CellCept(R)) to intravenous cyclophosphamide as induction therapy for active lupus nephritis were published in the New England Journal of Medicine, Volume 353, Number 21, November 24, 2005 in a paper entitled, "Mycophenolate Mofetil or Intravenous Cyclophosphamide for Lupus Nephritis".
This investigator initiated trial was funded by the grants program of the Food and Drug Administration's (FDA) Office of Orphan Products Development, with supplemental funding from Roche, the manufacturer of CellCept. The principal investigator is Ellen M. Ginzler, M.D., M.P.H., Professor of Medicine and Chief of Rheumatology at the State University of New York Downstate Medical Center, Brooklyn.
Based on Ginzler's IIT and acceptance of Aspreva's study protocol by regulatory authorities, the Company moved forward with its global phase III Aspreva Lupus Management Study (ALMS). The first patient in this study was treated in July 2005, and completion of the induction phase of the trial is expected in late 2006. Aspreva intends to include the data from Dr. Ginzler's IIT to supplement the results of the Company's trial in its applications for approval with regulatory authorities.
About Lupus Nephritis
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 the disease which, if 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. Clinicians estimate that one third to one half of lupus patients have lupus nephritis.
There has been no new approved treatment for SLE or lupus nephritis in over 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 has also been 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 is an emerging pharmaceutical company focused on identifying, developing and, upon regulatory approval, commercializing new indications for approved drugs and late stage drug candidates for patients living with less common diseases. 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. Aspreva is listed on the Nasdaq National Market under the trading symbol "ASPV" and on the Toronto Stock Exchange under the trading symbol "ASV".
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CONTACT: Sage Baker, Director, Corporate Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 270, sbaker@aspreva.com
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