Lupus Research Institute Hails Results of CellCept® Trial in People with Lupus Kidney Disease
New York, NY, June 05, 2010 --(PR.com)-- The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations are very encouraged by trial results released by Vifor Pharma, Galencia Group, and Roche demonstrating that the drug CellCept® (mycophenolate mofetil) helps in maintaining remission of lupus nephritis (lupus kidney disease).
After being treated for up to three years, participants in the trial taking CellCept® were able to stave off “treatment failure” for a significantly longer time than those on the “standard of care” drug, azathioprine (Imuran®). Treatment failure was defined as relapse of lupus nephritis, serious renal damage, or death.
“This is a significant finding in lupus research,” said LRI President Margaret G. Dowd. “As the organization uniquely dedicated to funding bold approaches to novel research in lupus, the Lupus Research Institute commends the companies for their commitment and perseverance in pursuing this promising therapy, and also thanks the hundreds of people with lupus who enrolled and took part in this important trial.”
Approximately 1 in 3 people with lupus develop kidney disease, and even after successful treatment the complication can still relapse.
Results Spell Hope: A Potential New Option for Staving Off Lupus Kidney Disease
In the trial, known as the Aspreva Lupus Maintenance Study (ALMS), 227 patients with lupus kidney disease who had been successfully induced into remission with either Cytoxan® (cyclophosphamide) or CellCept® received either CellCept® or azathioprine to maintain that remission. Patients were treated for up to three years.
The topline primary endpoint results for the trial indicate that CellCept® was highly statistically significantly superior to azathioprine in delaying the time to treatment failure.
Vifor Pharma plans to present more extensive trial results at the 9th International Congress on Systemic Lupus Erythematosus in Vancouver, Canada, in late June. Because of the positive results, the companies are currently exploring the possibility of seeking FDA approval for CellCept® for use in the treatment of lupus nephritis.
No new treatment has been approved for lupus in over 50 years.
About Lupus
Systemic lupus erythematosus (S.L.E.), commonly called lupus, is a chronic and potentially fatal autoimmune disorder and one of the nation’s least recognized major diseases. In lupus, the body's immune system forms antibodies that can attack virtually any healthy organ or tissue, from the kidneys to the brain, heart, lungs, skin, joints and blood. Lupus is a leading cause of cardiovascular disease, kidney disease, and stroke among young women. No new treatments for lupus have been approved in 50 years.
About the Lupus Research Institute:
Pioneering discovery to prevent, treat, and cure lupus.
The Lupus Research Institute (LRI) is the world’s leading private supporter of innovative research in lupus. The LRI champions scientific creativity and risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease. Founded by families and shaped by scientists, the LRI mandates sound science and rigorous peer review to uncover and support only the highest-ranked novel research. It is the only lupus organization to receive an A+ rating by the American Institute of Philanthropy, directly channeling 94 cents of every dollar donated right back to the programs supporting brilliant and determined lupus researchers. The LRI’s bold and proven research strategy consistently achieves the insights, breakthroughs, and solid results that are changing the course of lupus research and bringing new hope to people with lupus nationwide and around the world.
###
After being treated for up to three years, participants in the trial taking CellCept® were able to stave off “treatment failure” for a significantly longer time than those on the “standard of care” drug, azathioprine (Imuran®). Treatment failure was defined as relapse of lupus nephritis, serious renal damage, or death.
“This is a significant finding in lupus research,” said LRI President Margaret G. Dowd. “As the organization uniquely dedicated to funding bold approaches to novel research in lupus, the Lupus Research Institute commends the companies for their commitment and perseverance in pursuing this promising therapy, and also thanks the hundreds of people with lupus who enrolled and took part in this important trial.”
Approximately 1 in 3 people with lupus develop kidney disease, and even after successful treatment the complication can still relapse.
Results Spell Hope: A Potential New Option for Staving Off Lupus Kidney Disease
In the trial, known as the Aspreva Lupus Maintenance Study (ALMS), 227 patients with lupus kidney disease who had been successfully induced into remission with either Cytoxan® (cyclophosphamide) or CellCept® received either CellCept® or azathioprine to maintain that remission. Patients were treated for up to three years.
The topline primary endpoint results for the trial indicate that CellCept® was highly statistically significantly superior to azathioprine in delaying the time to treatment failure.
Vifor Pharma plans to present more extensive trial results at the 9th International Congress on Systemic Lupus Erythematosus in Vancouver, Canada, in late June. Because of the positive results, the companies are currently exploring the possibility of seeking FDA approval for CellCept® for use in the treatment of lupus nephritis.
No new treatment has been approved for lupus in over 50 years.
About Lupus
Systemic lupus erythematosus (S.L.E.), commonly called lupus, is a chronic and potentially fatal autoimmune disorder and one of the nation’s least recognized major diseases. In lupus, the body's immune system forms antibodies that can attack virtually any healthy organ or tissue, from the kidneys to the brain, heart, lungs, skin, joints and blood. Lupus is a leading cause of cardiovascular disease, kidney disease, and stroke among young women. No new treatments for lupus have been approved in 50 years.
About the Lupus Research Institute:
Pioneering discovery to prevent, treat, and cure lupus.
The Lupus Research Institute (LRI) is the world’s leading private supporter of innovative research in lupus. The LRI champions scientific creativity and risk-taking in the hunt for solutions to this complex and dangerous autoimmune disease. Founded by families and shaped by scientists, the LRI mandates sound science and rigorous peer review to uncover and support only the highest-ranked novel research. It is the only lupus organization to receive an A+ rating by the American Institute of Philanthropy, directly channeling 94 cents of every dollar donated right back to the programs supporting brilliant and determined lupus researchers. The LRI’s bold and proven research strategy consistently achieves the insights, breakthroughs, and solid results that are changing the course of lupus research and bringing new hope to people with lupus nationwide and around the world.
###
Contact
Lupus Research Institute
Liane Stegmaier
212-812-9881
www.LupusResearchInstitute.org
Liane Stegmaier
212-812-9881
www.LupusResearchInstitute.org
Contact
Categories