Epratuzumab is Safe and Effective for Treatment of Lupus in Phase II Trials

From our latest Research Update Newsletter:
Epratuzumab is an investigational agent for the treatment of lupus. It is an antibody that binds to a protein called CD22 on B cells, which are white blood cells known to be hyperactive in many people with lupus. The researchers hoped to learn whether epratuzumab could be a safe and effective treatment for people with moderate-to-severe lupus. They also wanted to find the best way to give the treatment (which dose and how often to give it) to get the best possible effects.

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New Data Shows Epratuzumab Provided Significant Efficacy for Patients with Moderate to Severe Systemic Lupus Erythematosus

UCB and Immunomedics Inc. announced today that a new lupus drug candidate, epratuzumab, provided a significant reduction in disease activity in patients with moderate to severe active systemic lupus erythematosus (SLE). Findings demonstrate that in a patient population with predominantly severe disease activity, epratuzumab is improving patients' health as quickly as week 12, with the emergence of improvements as early as week 8.

Read the company press release (PDF)

Lupus Foundation of America Says Results of Latest Study of CellCept® Provide Encouragement and Hope for People with Lupus Nephritis

(June 3, 2010 – Washington, DC) LUPUS FOUNDATION OF AMERICA – The Lupus Foundation of America today praised the results of a new long-term study for the treatment of lupus nephritis (lupus-related kidney disease) which demonstrated superiority of CellCept® (mycophenolate mofetil or MMF) to azathioprine (standard care) as a long-term treatment for lupus nephritis. The Phase III study results released by Vifor Pharma and Roche convincingly reached the primary endpoint of delaying treatment failure in patients with lupus nephritis who had successfully responded to induction therapy.

Responding to the release of data of the Aspreva Lupus Maintenance Study (ALMS), Sandra C. Raymond, President and CEO of the Lupus Foundation of America issued the following statement:

The results of this study provide more good news for the estimated 1.5 million Americans and the more than five million people worldwide who are living with lupus. Previous studies have provided convincing evidence that CellCept is better tolerated, and, more importantly to patients and their doctors, is associated with few serious or life-threatening infections and hospitalizations. It has been more than 51 years since the last drug was approved for lupus. We are greatly encouraged that people with lupus nephritis and their physicians will have additional options available to treat this potentially life-threatening and disabling complication of lupus.

The results of the study are significant because as many as forty percent of people with lupus will experience lupus kidney disease. The results of this study offer hope for an improved quality of life for these individuals. We look forward to reviewing data from the study when the company presents more details at the upcoming Ninth International Congress on Lupus, June 24-27 in Vancouver, Canada.

The Lupus Foundation of America is the nation’s foremost national voluntary health organization dedicated to finding the causes of and cure for lupus and providing support, services and hope to all people affected by lupus. The LFA conducts programs of research, education and advocacy through a national network of chapters, branches, and support groups. For more information about lupus, visit the LFA website at http://www.lupus.org/or call 800-558-0121 to receive a free information packet about lupus.

National Report Shines Light on Lupus 50-Year Treatment Drought

Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years -- since the Eisenhower Administration. The recommendations are included in the report Overcoming Barriers to Drug Development in Lupus, which is the outcome of a 9-month study commissioned by the Lupus Foundation of America, Inc. (LFA). The recommendations highlight the need for a national collaborative and coordinated effort among key stakeholders, including the FDA, the National Institutes of Health (NIH), researchers and scientists from academia, the LFA, and industry, to implement a range of initiatives that would create a path forward to develop a robust arsenal of safe, effective, and more tolerable treatments for this difficult to treat and devastating disease.

The report provides recommendations for each of the key stakeholders, which include expanding federal support for medical research on lupus, assessing the existing standard of care used in clinical trials, examining the interpretation of regulations pertaining to clinical trial design and related standards of evidence used to evaluate investigational drugs for lupus, expediting the discovery and validation of lupus biomarkers, and more.

Read the entire press release here.