Leading the way to a cure

Lupus Research Update: 2007 Volume 1

Volume 1, 2007 - Online Edition | In This Issue

The results are in! >
ALR's 2007 grant recipients >
One Love. One Cause. ALR Gala a Smashing Success >
The Faces of Lupus >
Advocacy Update — ALR Goes to Washington >
Research Results - Rituximab Results in Long-Term Immune Alteration in Some Lupus Patients >
Research Results — Exploring Toll-Like Receptors’ (TLR) Role in Lupus >
Research Results – The Role of Myeloid Dendritic Cells in Lupus >
News Flash – American College of Rheumatology Annual Meeting Update >
FDA Warning on Rituximab >
Drug Research and Development News >
Beyond the Research - 2007 Walk Sites Announced >

Drug Research and Development News

Epratuzumab: The U.S. Food and Drug Administration (FDA) lifted its clinical hold on trials of epratuzumab, allowing the resumption of trials by Immunomedics Inc., and its partner, UCB. UCB voluntarily suspended the trial last year after a routine audit of the manufacturing processes uncovered some sterility concerns. The FDA instituted the clinical hold so patients who had already benefited from the drug could resume treatment once the problem was addressed.

Epratuzumab is a humanized monoclonal antibody that targets an antigen called CD22, found on the surface of a certain class of lymphocytes. It’s thought to work by modulating B-cell function without entirely depleting B cells. It is on a fast track for FDA approval and is in Phase III clinical trials.

Atacicept: ZymoGenetics and Serono are developing atacicept for the treatment of lupus and other diseases. It works by interrupting the cytokine process that promotes B-cell survival and autoantibody production. Results from a Phase II trial presented at the 2006 American College of Rheumatology meeting in December showed the drug was well tolerated across all dose levels and schedules in the study and was associated with clear biologic activity. Atacicept is expected to enter Phase II clinical trials this year.

LymphoStat-B: This drug is being developed by Human Genome Sciences, Inc. In late 2006, the company announced that 76-week results of its Phase II clinical trial demonstrated belimumab reduced disease activity in lupus patients, exhibited durable biological activity, and appeared safe and well tolerated.

Lupusorb column: This combination drug/ medical device is being developed by the Israeli company Verto Medical Ltd. A drug containing a highly specific peptide that Verto researchers discovered is injected into the patient’s bloodstream, where it binds to certain autoantibodies. The patient then undergoes plasmapheresis, in which plasma is removed from whole blood, “cleared” of the autoantibodies, then returned to the patient. In January, the company announced it had received FDA approval for its first clinical trial. The combination Phase I and II study will be carried out in 10 patients to determine the safety and the ability of the Lupusorb column to reduce the circulating levels of antibodies associated with lupus.

Other drugs under development for lupus include:

CellCept® (mycophenolate): This drug from Roche is already approved for transplant patients. The company, in partnership with Aspreva Pharmaceuticals, is now studying its use in lupus patients with lupus nephritis in a Phase III trial.

Riquent® (abetimus): La Jolla Pharmaceutical continues to enroll patients in its Phase III clinical trial of abetimus for lupus nephritis. It is the first drug specifically developed for the treatment of lupus kidney disease. Abetimus works by reducing antibodies to the autoantibody dsDNA, frequently associated with lupus nephritis.

IPP-201101: This drug is being developed by London-based drug company Immupharma for the treatment of lupus. It has completed Phase II clinical trials with good results.

Rituxan (rituximab): This biologic drug, is in late-stage clinical trials for its use as a lupus treatment, and as a treatment for lupus nephritis. In December 2006, however, manufacturer Genentech suspended all studies after a warning from the FDA about two deaths in lupus patients from its off-label use.

MEDI-545: This monoclonal antibody from MedImmune Inc., targets interferon-alpha, levels of which are high in many patients with active lupus. Animals studies suggest the drug may suppress abnormal immune activity by binding to multiple interferonalpha subtypes seen in the blood of lupus patients. MEDI-545 entered Phase I clinical trials in the spring of 2006.



1.5 million

people in the U.S. have Lupus.

172 million

dollars committed to lupus research by the Lupus Research Alliance.

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