About the SERENE Study
SERENE is a Phase III, randomized, double-blind, placebo-controlled, parallel group, three-arm international study designed to evaluate the efficacy and safety of Rituxan plus MTX in patients with moderately-to-severely active RA who had an inadequate response to MTX monotherapy. A total of 509 randomized patients from 102 study sites across 11 countries received Rituxan (500 mg or 1000 mg) plus MTX or placebo plus MTX. The proportion of patients achieving an ACR20, the primary outcome measure, was assessed at week 24.
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation, irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
Rituxan, discovered by Biogen Idec, is a therapeutic antibody that first received Food and Drug Administration (FDA) approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL). It was also approved in the European Union under the trade name MabThera® in June 1998. In February 2006, Rituxan also received FDA approval in combination with MTX to reduce signs and symptoms in adult patients with moderately-to-severely active RA who have had an inadequate response to one or more TNF-antagonist therapies. Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B-cells. Rituxan does not target the entire immune system.
CD20 is not found on stem cells, pro-B cells (B-cell precursors), normal plasma cells, or other normal tissues.
Rituxan does not target stem cells in the bone marrow, and B-cells can usually regenerate and gradually return to normal levels after treatment with Rituxan.
Rituxan does not target plasma cells. These cells make antibodies that help fight infections.
In addition, Rituxan received FDA approval in September 2006 for first-line treatment of previously-untreated patients with follicular NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy and also for the treatment of low-grade NHL in patients with stable disease or who achieve a partial or complete response following first-line treatment with CVP chemotherapy.
Rituxan is being studied in primary progressive multiple sclerosis, for which there is currently no FDA-approved therapy. Rituxan is also being studied in other autoimmune diseases with significant unmet medical needs, including systemic lupus erythematosus, lupus nephritis and antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.
Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd. For a copy of the Rituxan full prescribing information, including Boxed Warning, please call 1-800-821-8590 or visit http://www.gene.com
YOu can bet Genentech and Biogen are already looking at IXS for a possible buyout- after all DR LEVY already on board with IXS's scientific research team and has ties to both those major pharmas.