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September 29, 2006
Aspreva Announces Achievement of
Targeted Patient Enrollment in Phase III Clinical Trial
for CellCept in Lupus Nephritis
Aspreva announced today completion of enrollment in their Phase III lupus nephritis study. This is an important event not only because it may provide important data for driving continued label expansion and revenue traction for CellCept, but also because there had been a theoretical concern that patients might not accept being randomized to placebo when CellCept mycophenolate was available to them, given the paucity of other good therapeutic options for lupus nephritis. Aspreva's ability to drive enrollment to completion in this and other studies was an important part of our original investment thesis, distinguishing the company from a number of other efforts in the class of "indication partnering" investment opportunities.
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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® (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 a 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."
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