Navigation Links
Promise of a New Lupus Treatment Is a Groundbreaking Achievement

BENLYSTA(TM) Successful in Second Pivotal Clinical Trial

WASHINGTON, Nov. 2 /PRNewswire-USNewswire/ -- Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today announced positive results from BLISS-76, the second of two large-scale phase III clinical trials of BENLYSTA(TM) (belimumab) for treating systemic lupus. A full presentation of results from BLISS-52 was recently shared at the 73rd Annual Scientific meeting of the American College of Rheumatology. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA).

Both trials demonstrate that treatment with BENLYSTA plus standard of care was superior to that of placebo (inactive agent) plus standard of care. BENLYSTA significantly reduced disease activity. If approved by the FDA, BENLYSTA would be the first drug ever developed and approved specifically for the treatment of lupus.

Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement.

"We are truly excited to receive this groundbreaking news! Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease. We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires.

"Conducting clinical trials in lupus has been extremely difficult due to many factors including the heterogeneity of the disease, the selection of appropriate clinical trial endpoints, and the confounding role of required background medications given to clinical trial participants. Human Genome Sciences and GlaxoSmithKline have proven that these barriers, while formidable, can be overcome.

"For decades the entire lupus research community has worked hard to better understand the causes and consequences of the disease. The fruits of that labor are starting to emerge. However, now is not the time for complacency. We must band together for lupus and continue to capitalize on the decades of research made possible through the efforts of the many dedicated researchers, physicians, people with lupus, and advocates.

"This announcement by HGS and GSK and the Overcoming Barriers to Drug Development in Lupus report, commissioned by the Lupus Foundation of America to outline recommendations on ways to overcome the barriers to lupus research, combine to serve as a call to action for a national coordinated effort to accelerate the pace of discovery, to develop more tolerable and effective treatments, and to ultimately find a cure for this perilous disease.

"We congratulate HGS and GSK on reaching this important milestone in lupus research and in the development of new therapies for lupus. We also extend our appreciation to the researchers and study volunteers who made this achievement possible: the physicians who have passionately committed to researching this disease, and the companies that continue to invest in finding new and necessary treatments for this devastating disease."

The next step in the process is for HGS and GSK to submit marketing applications in the United States, Europe and other regions during the first half of 2010. The LFA will closely follow this process, and continue to keep its constituents apprised of developments.

About Lupus

Lupus is an acute and chronic autoimmune disease in which the immune system is unbalanced, causing inflammation and tissue damage to virtually any organ in the body. Its health effects include heart attacks, strokes, seizures, miscarriages, and organ failure. Ninety percent of the people with lupus are women, and it is two to three times more common among African Americans, Hispanics/Latinos, Native Americans, and Asians. Lupus is unpredictable and potentially fatal.

About the LFA

The LFA is the foremost national nonprofit 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. Founded in 1977, the LFA has a nationwide network of nearly 300 chapters and support groups and operates programs of research, education, and advocacy.

SOURCE Lupus Foundation of America

SOURCE Lupus Foundation of America
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. New Study Shows Promise for Hydrogen Sulfide in Reducing Heart-Attack Damage, Ikaria Announces
2. New nanostructured thin film shows promise for efficient solar energy conversion
3. Phase 1 Studies Show Promise of QuatRxs Novel Compound, Sobetirome, for Lowering LDL Cholesterol Levels
4. New Robotic Imaging Technology Holds Promise of Improved Cancer Care
5. Nanoemulsion vaccines show increasing promise
6. NIST/NIH micromagnets show promise as colorful smart tags for magnetic resonance imaging
7. Nano-sized electronic circuit promises bright view of early universe
8. Telescope Embedded in Spectacle Lens Promises to Make Driving Easier for Visually Impaired
9. New carbon material shows promise of storing large quantities of renewable electrical energy
10. New research field promises radical advances in optical technologies
11. Cord Blood America Salutes President-Elect Obamas Promise to Lift Restrictions on Stem Cell Research
Post Your Comments:
(Date:11/24/2015)... 24, 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: ... the remaining 11,000 post-share consolidation (or 1,100,000 pre-share ... "Series B Warrants") subject to the previously disclosed ... 23, 2015, which will result in the issuance ... to the issuance of such shares, there will ...
(Date:11/24/2015)... (PRWEB) , ... November 24, 2015 , ... InSphero AG, ... 3D cell culture models, has promoted Melanie Aregger to serve as Chief Operating Officer. ... Aregger served on the management team and was promoted to Head of ...
(Date:11/24/2015)... LOS ANGELES , Nov. 24, 2015 ... a biotechnology company focused on the discovery, development and ... Marban , Ph.D., Chief Executive Officer, is scheduled to ... December 1, 2015 at 10:50 a.m. EST, at The ... York City . . ...
(Date:11/24/2015)... NEW YORK , November 24, 2015 ... in a European healthcare ... in which the companies will work closely together in identifying ... of unmet medical need. The collaboration is underpinned by a ... LSP fund. This is the first investment by Bristol-Myers Squibb ...
Breaking Biology Technology:
(Date:11/2/2015)...  SRI International has been awarded a contract of ... to the National Cancer Institute (NCI) PREVENT Cancer Program ... modern testing and support facilities, and analytical instrumentation to ... studies to evaluate potential cancer prevention drugs. ... Drug Development Program is an NCI-supported pipeline to bring ...
(Date:10/29/2015)... JOLLA, Calif. , Oct. 29, 2015  The ... a new report titled, "DNA Synthesis and Biosecurity: Lessons ... well the Department of Health and Human Services guidance ... issued in 2010. --> ... but it also has the potential to pose unique ...
(Date:10/29/2015)... Mich. , Oct. 29, 2015  Rubicon ... Genomics for U.S. distribution of its DNA library ... kit and Rubicon,s new ThruPLEX Plasma-seq kit. ThruPLEX ... enable the preparation of NGS libraries for liquid ... for diagnostic and prognostic applications in cancer and ...
Breaking Biology News(10 mins):