Navigation Links
Lupus Research Institute Highly Encouraged by Benlysta(TM) Trial Results
Date:7/19/2009

First Phase 3 Lupus Drug Trial in Decades to Show Effectiveness

NEW YORK, July 20 /PRNewswire-USNewswire/ -- The Lupus Research Institute (LRI) and its National Coalition of state and local organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline on the highly promising results of this landmark clinical trial of Benlysta(TM) (belimumab) for people with systemic lupus.

"We are very hopeful that we now are strongly on our way to the first new treatment for lupus in 50 years," said LRI President, Margaret G. Dowd. "We look forward to the impact that a new drug for lupus will have on the lives of the 1.5 million Americans, and millions more worldwide, who suffer from this devastating autoimmune illness."

"This is a major advance for patients, families, and physicians--the entire lupus community!" said Richard Furie, MD, chief of the division of rheumatology and allergy-clinical rheumatology at North Shore-LIJ Health System in New York. "There is no doubt that a drug approval will foster further drug development and additional discoveries."

In the double-blind, placebo-controlled, multi-center trial, known as BLISS-52, both dose levels of Benlysta(TM) plus standard of care were more effective than a placebo plus standard of care in people with serologically active systemic lupus. A total of 867 participants at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe, were enrolled in the trial.

"This is the first drug shown to be effective in ameliorating the signs and symptoms of lupus in decades," said Daniel J. Wallace, MD, clinical professor of medicine at the David Geffen School of Medicine at UCLA. "It represents a breakthrough for finally utilizing a methodology that enables researchers to demonstrate disease improvement. This will benefit lupus patients and their doctors."

Results of a second Phase 3 trial of Benlysta(TM), known as BLISS-76, are expected later this year. That trial has enrolled 826 participants at 133 clinical sites in 19 countries, primarily in North America and Europe.

BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in people with lupus.

First of its kind

"Benlysta(TM) is the first 'targeted biological agent' developed specifically for systemic lupus that has the potential to obtain FDA approval. . .with the positive results of this 52-week trial and pending the results of the 76-week trial," said Tammy O. Utset, MD, MPH, an associate professor of medicine at the University of Chicago.

"HGS took a very ambitious development approach--huge international concurrent trials which represent a large investment in systemic lupus therapy," Utset added.

"The lupus community commends HGS and GlaxoSmithKline for their commitment and perseverance in finally bringing this potential new lupus treatment to trial," said Dowd. "And we thank the hundreds of people with lupus who enrolled and took part in this important trial. Participation like theirs is critical to finding answers to this illness."

The LRI builds the research pipeline and assists in recruiting patients to participate in trials to bring safe and effective treatments to market for people with lupus.

To learn more about lupus clinical trials, log on to www.LupusTrials.org.

About Lupus

Systemic lupus erythematosus (SLE) or lupus, one of the nation's least recognized major diseases, is a chronic and potentially fatal autoimmune disorder that affects more than 1.5 million Americans, primarily women in their childbearing years. 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. No new treatments for lupus have been approved in almost 50 years and many currently used treatments are as toxic as the disease itself. Lupus is a leading cause of premature cardiovascular disease, kidney disease and stroke among young women.

About the Lupus Research Institute

Pioneering discovery to prevent, treat and cure lupus The Lupus Research Institute (LRI)--the world's leading private supporter of innovative research in lupus--champions innovation, encourages scientific creativity and risks exploring uncharted territory to bring new scientific solutions to the complex and dangerous autoimmune disease of lupus. Founded by families and shaped by scientists, the Institute mandates sound science and rigorous peer review to uncover and support only the highest ranked novel research. Its bold and proven research strategy places the LRI at the forefront of lupus science as the Institute consistently achieves the breakthrough discoveries, novel insights and solid results that are changing the course of lupus research and bringing new hope to people with lupus nationwide. To learn more about lupus and the Lupus Research Institute, visit www.lupusresearchinstitute.org.


'/>"/>
SOURCE Lupus Research Institute
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. New Risk Gene for Rheumatoid Arthritis and Lupus Opens Door to More Effective Treatments
2. Coley Pharmaceutical Group Diversifies Pipeline with First-in-Class TLR Antagonist for the Treatment of Systemic Lupus Erythematosus
3. Human Genome Sciences Reports Positive Data from Long-Term Treatment with LymphoStat-B(R) in Patients with Active Systemic Lupus Erythematosus
4. Tolerx Achieves Milestone with Completion of Phase Ib Clinical Study of TRX1 in Cutaneous Lupus Erythematosus
5. Steps Toward Stopping Autoimmune Disease: International Consortium Identifies Genes Linked to Lupus
6. Rigels R788 Slows Progression of Murine Lupus in Preclinical Studies
7. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. Human Genome Sciences Reports Positive Long-Term Data for LymphoStat-B in Patients With Active Systemic Lupus Erythematosus
10. Medarex Announces Initiation of Phase 2 Clinical Development Program for the Treatment of Lupus
11. Study Results Show Epratuzumab Provided Clinically Meaningful Reduced Disease Activity in Patients With Lupus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Research and Markets has ... 2015-2025: Applications, Technologies, Forecasts" report to their ... Electronics, Smart Skin, Structural Health Monitoring, Composite Smart ... electronics involves electronic and/or electrical components and circuits ... structures such as vehicle bodies or conformally placed ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson has ... he has implemented orthobiologic procedures as a method for treating his patients. The ... first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is World Sickle ... chronic pain and the benefits of holistic treatments, Serenity Recovery Center of ... Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of the red ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions today ... cultivation and processing operations at its production facility, and opened its first two ... the manufacturer of a complete system of proactive air and surface purification solutions ...
Breaking Medicine News(10 mins):