VICTORIA, Sept. 29 /PRNewswire-FirstCall/ - Aspreva Pharmaceuticals Corporation , an emerging pharmaceutical company focused on increasing the pool of evidence-based medicines available for patients living with less common diseases, today announced the completion of the targeted enrolment of 358 patients in its global phase III clinical trial for CellCept(R) (mycophenolate mofetil) in the treatment of lupus nephritis. The study is assessing the safety and efficacy of CellCept in inducing response and maintaining remission in patients with biopsy-proven lupus nephritis.
The two-phase induction and maintenance study is a randomized open-label comparison of mycophenolate mofetil with the current standard of care, intravenous cyclophosphamide, for the first six months or induction phase, followed by a double-blind comparison of mycophenolate mofetil with azathioprine for up to three years or maintenance phase. The primary end point for the induction phase is an improvement in proteinuria and stabilization of serum creatinine. The Company expects database lock on the induction phase of the study in the second quarter of 2007 with submission of an sNDA to the United States Food and Drug Administration (FDA) in the fourth quarter of 2007.
Dr. Richard Jones, Senior Vice President, Clinical and Regulatory Affairs at Aspreva, said, “Our clinical trial in lupus nephritis is our largest phase III study currently underway, and we are very pleased with our rapid development in this challenging clinical area. The successful completion of targeted patient enrolment reflects the cooperation between Aspreva, key opinion leaders, advocacy groups and the medical community, which together enabled us to attract patients and physicians to our clinical trial in this complex disease area. We couldn’t achieve this success without the global support of our employees, our partner, Roche, and the patients and physicians represented by the 117 global clinical sites. We look forward to sharing clinical results upon completion of this trial and the associated regulatory filings to follow.”
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 the United States 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 Roche’s leading 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 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.
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 is listed on the Nasdaq Global Select Market under the trading symbol “ASPV” and on the Toronto Stock Exchange under the trading symbol “ASV”.
This press release contains forward-looking statements or information within the meaning of the Private Securities Litigation Act of 1995 and applicable Canadian Securities Legislation. These include, without limitation, statements or information related to our strategy, future operations, clinical trials, prospects and plans of management. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements or information, although not all forward-looking statements or information contain these identifying words. These forward-looking statements or information are based upon our current expectations and we may not actually achieve the plans, approvals, intentions or expectations disclosed in our forward-looking statements or information. Forward-looking statements or information involve risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward-looking statements or information as a result of these risks and uncertainties, which include, without limitation, risks related to difficulties or delays in 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, difficulties or delays in obtaining regulatory approval, the FDA may finally determine that the design and planned analysis of our clinical trials do not adequately address the trial objectives in support of our regulatory submission, 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 or information, which speak only as of the date of this press release. All forward-looking statements or information are qualified in their entirety by this cautionary statement, and Aspreva undertakes no obligation to revise or update any forward-looking statements or information as a result of new information, future events or otherwise after the date hereof.
CONTACT: Sage Baker, Vice President, Investor Relations and Corporate Communications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 270, sbaker@aspreva.com
Aspreva Pharmaceuticals
CONTACT: Sage Baker, Vice President, Investor Relations and CorporateCommunications, Aspreva Pharmaceuticals, (250) 744-2488 ext. 270,sbaker@aspreva.com
