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Rituxan Results, Although Disappointing, Can Help Create Better Drugs and Build Better Trials for Lupus

Learnings from landmark study across multiple organ systems will inform progress in this complex autoimmune disease

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GENENTECH AND BIOGEN IDEC ANNOUNCE TOP-LINE RESULTS FROM PHASE II/III CLINICAL STUDY OF RITUXAN IN SYSTEMIC LUPUS ERYTHEMATOSUS

SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. – April 29, 2008 – Genentech, Inc. (NYSE: DNA) and Biogen Idec, Inc. (Nasdaq: BIIB) announced today that a Phase II/III study of Rituxan® (rituximab) for systemic lupus erythematosus (SLE, commonly called lupus) did not meet its primary endpoint defined as the proportion of Rituxan treated patients who achieved a major clinical response (MCR) or partial clinical response (PCR) measured by BILAG, a lupus activity response index, compared to placebo at 52 weeks. The study also did not meet any of the six secondary endpoints. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.

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Profound Immune System Discovery Opens Door to Halting Destruction of Lupus

(New York, NY) December, 2007 – A researcher funded by the Lupus Research Institute (LRI) has discovered an entirely new and powerful molecular switch that controls the inflammatory response of the immune system. The major finding, reported in the December 14th issue of the journal Cell, means that new methods can now be pursued to shut down uncontrolled inflammation, restore immune system regulation, and treat chronic autoimmune disorders such as lupus.

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Lupus Research Institute Launches Novel Studies in Human Lupus

The Lupus Research Institute (LRI) invites scientists with innovative ideas about what goes wrong in human lupus and ways to fix it to apply for grant funding to mount novel investigations in Human Lupus Biology.

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Cell Signaling Glitch Contributes To Lupus Progression

Immune cells that would normally die in healthy people accumulate in bodies of patients who have lupus and contribute to the disease, according to new Saint Louis University research published in the Feb. 15 issue of Immunity.

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Heart Disease Is A Major Complication Of Lupus - February Is National Heart Month

Heart disease is a major complication of lupus and is now a leading cause of death among people living with autoimmune disease.

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La Jolla Pharmaceutical Company Reports Progress In International Phase 3 Riquent(R) Study

La Jolla Pharmaceutical Company (Nasdaq:LJPC) announced significant progress in its ongoing double-blind, placebo-controlled randomized Phase 3 trial of Riquent(R) (abetimus sodium), its drug candidate for systemic lupus erythematosus ("lupus" or "SLE"), including additional safety data on the trial's higher doses.

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DNA Variations Signal Lupus Risk

Scientists have pinpointed a set of common variations in human DNA that signal a higher risk for lupus in women who carry them. Some of these variations are more common in relatives of lupus patients, which may help future studies examining whether lupus is more prevalent among certain racial and ethnic groups, according to a new study.

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Genetic Link To Lupus, NHS Response

Scientists have identified six or more "rogue genes" behind the disease lupus, reports the Daily Mail. Lupus affects nearly 50,000 women in Britain and it is a complex disease which "occurs when the immune system turns on the body", the newspaper said.

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Drugs Used To Treat Rheumatoid Arthritis May Have Hidden Benefits

Powerful drugs used to treat patients with rheumatoid arthritis have a profound, previously unrecognized effect on the immune system, breaking up molecular "training camps" for rogue cells that play an increasingly recognized role in autoimmune diseases like rheumatoid arthritis and lupus.

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Discovery Of New Genetic Mutation That Halts The Development Of Lupus

The new study was published in the January 18 edition (Volume 28, Issue 1) of the journal Immunity.

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Genes Linked To Lupus Identified By International Consortium

A landmark genetic study has identified multiple genes linked to systemic lupus erythematosus (SLE), or lupus, a debilitating autoimmune disease that affects an estimated 1.4 million Americans.

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Profound Immune System Discovery Opens Door to Halting Destruction of Lupus

Lupus Research Institute Funds Innovative Hypothesis and Scientific Breakthrough

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National Funding For Lupus Research Institute

The Lupus Research Institute (LRI) strategy of backing innovative investigations into systemic lupus, the autoimmune disease, has now yielded an unprecedented $30 million in large-scale funding from the National Institutes of Health and other government and private sources, an independent progress report has determined.

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Mycophenolate Mofetil Reduces Lupus Flares and Cuts Prednisone Use: Presented at ACR

BOSTON, MA -- November 13, 2007 -- Not only does mycophenolate mofetil (MMF) treatment significantly reduce the total number of flares in patients with systemic lupus erythematosus (SLE), but it also reduces the daily use of prednisone dose by these patients.

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Researchers Investigate Ways To Detect Lupus Associated Kidney Disease

High urinary levels of certain molecules might have the potential to serve as biomarkers for a potentially life shortening kidney ailment caused by the autoimmune disease lupus, UT Southwestern Medical Center researchers have found.

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Human Genome Sciences Reports Positive Data From Long Term Treatment With LymphoStat-B(R) In Patients With Active Systemic Lupus Erythematosus

Human Genome Sciences, Inc. (Nasdaq: HGSI) announced the presentation of Phase 2 clinical results demonstrating that LymphoStat-B(R) (belimumab) achieved a sustained improvement in disease activity across multiple clinical measures, decreased the frequency of disease flares over time, and was well tolerated through 2.5 years on treatment in combination with standard of care in patients with active systemic lupus erythematosus (SLE).

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Therapy Effective For Reducing Lupus Flares

Mayo Clinic researchers have shown that an immunosuppressive drug used in organ transplant cases is effective in reducing flare-ups in patients with systemic lupus erythematosus (SLE).

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New Round of Lupus Research Institute Awards Brings Promise of More Breakthroughs

12 Grants Enable Testing of Innovative Hypotheses

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BREAKING NEWS: FDA Heightens Warning About Miscarriage, Birth Defects With Drug Used Off-Label for Lupus Nephritis

October 31, 2007

ROCKVILLE, Maryland, and NUTLEY, New Jersey—The US Food and Drug Administration (FDA) and Roche Laboratories, Inc, today issued a warning that mycophenolate mofetil (MMF, CellCept®, Roche) has been positively linked to first-trimester miscarriages and birth defects in the children of women who have taken it.1

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Lupus Research Institute Opens New Directions in Autoimmune Disease Research

Early Immune System Error Challenges Basic B-Cell Biology in Lupus

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Lupus Research Institute Triggers Cascade of New Links—and Possible Solutions—to Early Heart Disease in People with Lupus

The Lupus Research Institute (LRI), the only organization singularly devoted to innovative science in lupus, reports that misbehavior among the cells that form the linings of blood vessels (called endothelial cells) in people with lupus puts them at dramatically increased risk for early heart disease and stroke.

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Clinical Trials For Lupus Underway After Decades Of Drought

For the first time in decades, a significant number of clinical trials are being conducted to seek a treatment, perhaps even a cure, for lupus, a chronic and potentially fatal autoimmune disease that affects more than 1.5 million Americans -- 10,000 in Los Angeles County alone.

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Dept. Of Defense Support For Lupus Research Provides 5 Million Dollars In New Funding

The Department of Defense (DoD) Congressionally Directed Peer Reviewed Medical Research Program (PRMRP) has awarded $5 million in new funding to support important research studies on lupus and lupus biomarkers.

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News From The American Chemical Society

Vaccine-like treatment shows promise for fighting lupus

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Wanted: Lupus Patients for Clinical Trials

NEW YORK, NY—The lupus therapeutic landscape is changing slowly but dramatically because of the advent of molecular tools (such as the sequencing of the human genome) and the development of targeted treatments.

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Hormone Therapy Does Not Worsen Lupus But May Increase Thrombosis Risk

TLALPAN, Mexico—Women with systemic lupus erythematosus (SLE) are at increased risk for premature menopause, with its attendant risks of osteoporotic fracture, however, hormone therapy (HT) is a possible treatment.

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New Risk Gene For Rheumatoid Arthritis And Lupus Opens Door To More Effective Treatments

Scientists at The Feinstein Institute for Medical Research have identified a critical gene that increases a person's risk for rheumatoid arthritis and systemic lupus erythematosus, and may be involved with other autoimmune diseases.

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Pulse IVMP Treatment May Decline With the Advent of New Lupus Therapies

MANCHESTER, England— Clinicians rely on intravenous methylprednisolone (IVMP) for cooling acute flares of systemic lupus erythematosus (SLE), but newer emerging treatments are expected to challenge IVMP both for treatment of acute flares and in longer-term maintenance treatment of lupus nephritis and nonrenal lupus manifestations.

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Lupus Patients May Benefit From Organ-Transplant Rejection Drug

A compound related to a drug used in humans to prevent organ-transplant rejection attacks a key biochemical process in the faulty immune cells of lupus-prone mice, suggesting a possible new approach to combating the disease, UT Southwestern Medical Center researchers have found.

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Malaria drugs cut cancer risk in lupus patients

Drugs used to treat malaria appear to reduce the risk of malignancy in patients with systemic lupus erythematosus, Spanish researchers report in the Annals of the Rheumatic Diseases.

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Sperm Abnormalities Seen In Male Lupus Patients

Science Daily — The prognosis for systemic lupus erythematosus (SLE), an autoimmune disease that mainly affects women in their reproductive years, has improved recently, prompting a shift toward improving quality of life. For men with SLE, concerns have been raised about their future fertility.

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Can B-Cell Depletion With Rituximab Trigger Psoriasis?

LEEDS, UK—Three patients who developed new-onset psoriasis after rituximab (Rituxan®) treatment have raised a troubling new concern about the growing use of this B-cell depleting therapy in a widening group of rheumatic diseases. The cases are reported in the August issue of Arthritis & Rheumatism.1

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Hydroxychloroquine May Stave Off Lupus Onset

OKLAHOMA CITY, Oklahoma—Catching lupus early and treating it with hydroxychloroquine may delay or prevent the onset of systemic lupus erythematosus (SLE) in certain high risk individuals, according to provocative new findings in the journal Lupus.1

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New Research May Predict Who Is At Risk To Develop Lupus

Certain families produce higher levels of a specific molecule, called interferon-alpha, that primes the body's immune system to turn on, and in some cases initiate an autoimmune attack on itself, according to new research from Hospital for Special Surgery in New York City.

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Lupus And Genetic Mutations Linked By Research

A gene discovered by scientists at Wake Forest University School of Medicine has been linked to lupus and related autoimmune diseases.

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Despite different triggers of disease, all roads lead to lupus

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MedImmune Advances Potential Treatment For Patients With Lupus

MedImmune, Inc. today announced that it has begun dosing patients in a multi-dose, Phase 1b clinical trial with its monoclonal antibody (MAb) targeting interferon-alpha, known as MEDI-545.

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BioPharm Business News: Aspreva, Roche Report Preliminary Results for Phase III Study of CellCept in Lupus Nephritis; Fail to Achieve Primary Objective of Superiority to Intravenous Cyclophosphamide

Aspreva Pharmaceuticals Corp (VICTORIA, British Columbia), an emerging pharmaceutical company focused on identifying, developing, and commercializing new indications for approved drugs and late-stage drug candidates for patients with less common diseases, and Roche (BASEL, Switzerland) released preliminary results from a phase III clinical trial comparing CellCept (oral mycophenolate mofetil, MMF) with intravenous cyclophosphamide (IVC), the current standard of care in patients suffering from lupus nephritis.

Continue reading "BioPharm Business News: Aspreva, Roche Report Preliminary Results for Phase III Study of CellCept in Lupus Nephritis; Fail to Achieve Primary Objective of Superiority to Intravenous Cyclophosphamide" »


BioPharm Business News: Pfizer's Lyrica® Receives FDA Approval for Fibromyalgia in Adults

Pfizer Inc (NEW YORK, NY) announced that the US FDA approved Lyrica® (pregabalin) capsules CV for the management of fibromyalgia, one of the most common chronic, widespread pain conditions in the US. Lyrica, which received a priority review, is the first FDA-approved medicine for the condition in adults.

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Treatment With Belimumab Showed Improvement In Symptoms In 46 Percent Of Lupus Patients At 52 Weeks

Treatment with belimumab resulted in a sustained improvement of systemic lupus erythematosus (SLE or lupus) disease activity in 46% of patients at week 52, according to a novel combined responder index in results presented at EULAR 2007, the Annual European Congress of Rheumatology in Barcelona, Spain.

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Over 1/3 Of Refractory Lupus Patients Remain Stable At Long Term Follow-up After Receiving B-Cell Depletion Therapy

Findings reported today at EULAR 2007, the Annual European Congress of Rheumatology (EULAR) in Barcelona, Spain, reveal a treatment disparity between female and male patients with rheumatoid arthritis (RA).

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The Future Directions of Lupus Research

Thanks to The Lupus Alliance of LI/Q and other lupus agencies from around the Nation the NIH has posted the "Future Directions of Lupus Research" on their website for public comment.

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For the first time in over 40 years, new medications are being designed and tested for lupus!

For the first time in over 40 years, new medications are being designed and tested for lupus, prompting The Lupus Alliance of LI/Q to urge everyone who has lupus to get involved and be part of the cure!

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NIAMS releases "The Future Directions of Lupus" report.

Due to the recent congressional lobbying by the Lupus Alliance of LI/Q, the National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) has posted “The Future Directions of Lupus” on their website for public comment.

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Scientists Spot Key Autoimmune Disease Genes

MONDAY, Jan. 22 (HealthDay News) -- The identification by U.S. scientists of genes thought to be key to autoimmune disorders could be a big step toward new treatments for these illnesses, which include lupus, rheumatoid arthritis and type 1 diabetes.

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Lupus Meeting News: Environment Interaction Seen As Next Step in Lupus Genetics

SHANGHAI, China—Family genetic linkage studies, candidate gene analysis, and whole genome scans have helped researchers identify several gene polymorphisms associated with a high risk for systemic lupus erythematosus (SLE).

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Lupus Meeting News: Not Just Dust: Microparticles Suspected of Role in Lupus

SHANGHAI, China—Microparticles are elevated in the blood of patients with systemic lupus erythematosus (SLE) and may act as important mediators of autoimmunity and inflammation, Steffen Gay, MD, will report at this week’s 8th International Congress on SLE.1

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Department Of Defense Provides Another 2 Million Dollars For Lupus Research, USA

The U.S. Department of Defense (DoD) Congressionally-Directed Medical Research Program has awarded more than 2 million dollars in additional grants for research on lupus and lupus biomarkers.

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Human Genome Sciences And GlaxoSmithKline Initiate Second Phase 3 Clinical Trial Of LymphoStat-B(R) In Systemic Lupus Erythematosus

Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that dosing has begun in BLISS-52, the second of two pivotal Phase 3 clinical trials of LymphoStat-B(R) (belimumab) in patients with active systemic lupus erythematosus (SLE).

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Surge in LRI Biomarker Research Signals New Hope for Diagnosing and Managing Lupus

In its commitment to staying open to powerful new ideas in lupus research, the Lupus Research Institute has reaped a remarkable reward for the more than 1.5 million Americans and millions more worldwide with this devastating disease--a panel of candidate biomarkers that may have the potential to change the way that lupus affects their lives.

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Small Study of Epratuzumab Shows Promise in Mild to Moderate Lupus

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BLyS Isotope May Serve as Lupus Biomarker

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Blocking CD134 Stimulator May Be Effective Way to Prevent Lupus Nephritis

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Diabetes Drugs Might Help Prevent Heart Disease in Lupus

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provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus