Stock investments ranging from Biotech, Pharmaceutical, and Medical Devices in the Healthcare Sector. Covering Clinical Trial recommendations and FDA Approvals.
Showing posts with label Systemic lupus erythematosus. Show all posts
Showing posts with label Systemic lupus erythematosus. Show all posts
Elmo the Investment Banker is killing traders.
Stick to Sesame Street Elmo.
You aren't cut out for Wall St.
Just after Tuesday's FDA Recommendation for Human Genome Sciences' Lupus Therapy Benlysta, Citigroup and Bank of America downgraded the stock. Obviously, they mistakenly shorted the stocks and wanted to get their money back after guessing wrong on the FDA decision. The drug was recommended by a 13-2 vote. It is very similar to other cases in recent FDA Approvals, where the stock has actually has gone down on good news, not up.
Manipulating shorts cover their positions by making sure they got analysts on their side to downgrade a stock in case a Panel vote goes against them. Here is a perfect example of how Hedge Fund Shorts cover their positions:
Two downgrades Wednesday morning, one each from Citi and Bank of America/Merrill Lynch, reflected these new concerns and sent Human Genome shares down 7% to $23.98 in early trading.
An advisory panel convened by the U.S. Food and Drug Administration voted 13-2 Tuesday night to recommend Benlysta's approval as the first new lupus therapy in 50 years.
Everything you need to know about Tuesday's FDA panel recommendation for Human Genome Sciences therapy for Lupus, Benlysta. If approved Benlysta would be the first approved therapy in 50 years for Lupus. Friday the FDA released the notes for the upcoming panel review Tuesday, November 16th. Concerns for the panel Tuesday were an increased risk of suicide, risk of infection, and decreased efficacy in African-American patients, who are more prone to Lupus. Forbes' The Medicine Show Blog with Matthew Herper highlighted some of these concerns. Benlysta is teamed up with Glaxo SmithKline and if approved Human Genome Sciences will share marketing costs and profits. The expected market is anywhere between 1-3 Billion.
I think the benefits for the drug outweigh any concerns and it could be approved December 9th by the FDA. With that being said though, the FDA has rejected a lot of drugs this year and is very conservative. There are some concerns and more clinical trials could be advised before approval. We will have to see. Today's FDA review notes had concerns with the drug's suicide rate and it's efficacy for African-Americans, who are more likely to have Lupus. The concerns dropped the stock and has investors spooked, but I still think that it will be recommended. I hope I am not wrong on this one.
Rumors of Glaxo's takeover of Human Genome Sciences for $30/share have pushed the stock up considerably today. Human Genome Sciences stock (HGSI) was up $2.03 to $19.21 per share in afternoon trading with a gain of 11.79%. Aftermarket trading is up +0.46 to 19.66, another gain of 2.40%. I see this as only a rumor but it does make some since as Human Genome and Glaxo have been partner's since 1993. Human Genome Sciences worked together and received royalties from Glaxo in 2006 for the Diabetes medication Syncria. April 2008 saw HGSI reacquiring the rights for the HGS-ETR1 and HGS-ETR2 oncology programs from Glaxo.
So what is going on here? Has Glaxo seen results from their second set of pivotal Phase III trial and are ready to make a deal? Results are set to be released in November for their Lupus drug BENLYSTA. HGSI press releases from their website can be found here Benlysta Results. For more takeover target information check out the Washington Biz Journal's article HGSI:a takeover target?. MedicalNewsToday posted an article in June announcing the Lupus drug's positive results on Benlysta.
Regardless, I see this as positive financial news for Human Genome Sciences which once traded in March around 0.45. I'm not sure I believe the hype in the rumor but I do like the news coming in and anticipation for results in November. Many analysts see this stock as undervalued and have a target range around 26/share.
Human Genome Sciences has declined to comment on the rumor. Human Genome corporate leaders have stated in the past that they are seeking independence in approval of these 2 trials and have no reason to change that. This was quoted by CEO Tom Watkins in July: “We’re really focused on getting the drugs to patients. We think we have the capability and wherewithal to do it on our own, and we don’t see any reason why that would change.”
With that said I don't know. I've seen CEOs take the money and run but I don't think this is the case. Just a hunch. Rumors have surrounded Spectrum Pharma as a takeover target for Bayer AG recently and those did not fall through either. It is a good marketing tool to push the stocks price up and it works pretty well. Needless to say I like Human Genome's chances with their Phase III results in November. I do see the stock price going higher with positive results and after all is said and done with this rumor I see the price will value out and be a good buy. Just a reminder not to chase stocks. Buy at a valued price and good things will happen.
Breaking News for Human Genome Sciences. Lupus drug mets primary endpoints for Phase III clinical trials. I like the stock. I see genomics research as the future for the Biotech industry and Lupus is a debilitating disease that is life threatening. This is promising news for investors and I see this as a good long term investment. HGSI
From MedicalNewsToday.com Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced its Phase 3 clinical development program for LymphoStat-B(TM) (belimumab) in patients with active systemic lupus erythematosus (SLE).
"Advancing LymphoStat-B to Phase 3 development is a critically important step in the evolution of HGS into a commercial organization," said H. Thomas Watkins, President and Chief Executive Officer, Human Genome Sciences. "We have worked closely with our collaborator GlaxoSmithKline over the past months to analyze and assess the data from our Phase 2 study, and we share a vision of the important role that LymphoStat-B may play for patients with SLE."
HGS designed the Phase 3 program in collaboration with GlaxoSmithKline (GSK) and leading international SLE experts, and expects to initiate Phase 3 trials of LymphoStat-B before the end of 2006. HGS has met with both the U.S. Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA), and has received agreement on the major components of the Phase 3 program, including the primary efficacy endpoint, target patient population, and dose selection. HGS plans to submit the final LymphoStat-B Phase 3 protocols to FDA soon for a Special Protocol Assessment (SPA).
"We are encouraged by our discussions with regulatory authorities both in the U.S. and in Europe, and by their positive response to our proposed Phase 3 trial design, especially the target patient population and primary efficacy endpoint," said David C. Stump, M.D., Executive Vice President, Drug Development, Human Genome Sciences. "The design of the LymphoStat-B Phase 3 development program includes a primary efficacy endpoint that emerged directly from the results of our Phase 2 clinical trial. The endpoint is a combined patient response rate that includes elements of the SELENA SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index. These measures are well known to clinical investigators with experience in SLE. The Phase 2 results show that LymphoStat-B, as measured by this combined response rate, significantly reduced disease activity in serologically active patients. We look forward to moving ahead with site activation and patient enrollment over the next few months."
"It has been nearly forty years since a new drug has been approved by the FDA for lupus," said Sandra C. Raymond, President and Chief Executive Officer, Lupus Foundation of America. "Lupus is a life-threatening and devastating chronic illness. We need safer and more effective therapies. We will be following the LymphoStat-B Phase 3 clinical trials with great interest, both because of the significant unmet medical need that exists and because LymphoStat-B is being studied as a treatment for the underlying disease of lupus, rather than for the treatment of individual symptoms."
About the Design of the LymphoStat-B Phase 3 Development Program
As proposed by HGS, the Phase 3 development program for LymphoStat-B will include two double-blind, placebo-controlled, multi-center Phase 3 superiority trials that will evaluate the efficacy and safety of LymphoStat-B plus standard of care, versus placebo plus standard of care, in the treatment of patients with active SLE. The primary efficacy endpoint of both studies is the patient response rate at Week 52, as defined by: a reduction from baseline in the SELENA SLEDAI score of at least 4 points; no worsening in Physician's Global Assessment (with worsening defined as an increase in PGA of more than 0.30 points from baseline); no new BILAG A organ domain score and no more than 1 new BILAG B organ domain score from baseline.
The total duration of the two studies will differ, at 76 weeks and 52 weeks, respectively. Aside from duration, the two studies will have similar protocols. In each of the two Phase 3 trials, approximately 810 patients will be enrolled and randomized to 1 of 3 treatment groups (1 mg/kg LymphoStat-B, 10 mg/kg LymphoStat-B, or placebo). Patients will be dosed intravenously on Days 0, 14 and 28, then every 28 days. To be eligible for enrollment in the Phase 3 trials, patients must be serologically active, with unequivocal antinuclear antibody (ANA) test results assessed at 2 independent time points (HEp-2 ANA > 1:80 and/or anti-dsDNA > 30 IU/mL). Patients also must be on a stable SLE treatment regimen for a period of at least 30 days prior to Day 0.
Important secondary endpoints will include the patient response rate at Week 76, the SF-36 Health Survey physical component summary score, fatigue measures, and the percentage of patients with reduction from baseline in average prednisone dose at Weeks 40-52. Safety and tolerability will be evaluated by an independent Data Monitoring Committee throughout both studies.
About the Phase 2 Trial Results Reported in June 2006
In June 2006, HGS reported the full presentation of data from a Phase 2 clinical trial of LymphoStat-B in 449 patients with active SLE. The Phase 2 study was designed as a randomized, double-blind, placebo-controlled, dose- ranging superiority trial to evaluate the safety, tolerability and efficacy of LymphoStat-B plus standard of care, versus placebo plus standard of care. Participants were randomized to receive one of three different doses of LymphoStat-B or placebo (1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period, in addition to standard-of-care therapy.
The Phase 2 results show that LymphoStat-B produced statistically
significant reductions in disease activity versus placebo, exhibited clinically relevant biological activity, and was safe and well tolerated. Among the Phase 2 study findings was a significantly improved response rate among seropositive patients at Week 52, as defined by an improvement in SELENA SLEDAI score of 4 points or greater, no BILAG worsening, and no worsening in Physician's Global Assessment (46% for LymphoStat-B versus 29% for placebo, p<0.01). (Seropositivity is defined by baseline HEp-2 ANA >1:80 and/or anti- dsDNA >30 IU/mL.) The Phase 2 results support the further evaluation of LymphoStat-B in Phase 3 clinical trials.
About the Collaboration with GSK
In July 2005, GSK exercised its option under a June 1996 agreement to co- develop and co-commercialize LymphoStat-B with HGS throughout the world. HGS and GSK have now entered into a definitive co-development and co- commercialization agreement under which HGS will have responsibility for conducting the LymphoStat-B Phase 3 trials, with assistance from GSK. HGS will receive a $24 million payment from GSK in the third quarter of 2006, in consideration of GSK's right to co-develop and co-commercialize LymphoStat-B. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the agreement.
About LymphoStat-B
LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(TM). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus, rheumatoid arthritis, and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies -- antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies demonstrate that B-cell antagonists can reduce autoantibody levels and help control autoimmune disease activity.
LymphoStat-B is a Human Genome Sciences drug, created through a collaboration with Cambridge Antibody Technology. It has received a Fast Track Product designation from the FDA for its potential use in treating SLE and has been selected for participation in the FDA's Continuous Marketing Application Pilot 2 Program.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, life-threatening disease. Between 200,000 and 500,000 people are diagnosed with SLE in the United States alone. The Lupus Foundation of America estimates that approximately 1.5 million Americans suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people between the ages of fifteen and forty-five. About 90 percent of the individuals diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash, and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels, and blood disorders. For more information on lupus, visit the Lupus Foundation of America at http://www.lupus.org, or the National Institute of Arthritis and Musculoskeletal and Skin Diseases at http://www.niams.nih.gov.
From BioMedReports
Human Genome Achieves Lupus Drug Goals With DSG's EDC Sunday, 16 August 2009 22:30
MALVERN, Pa.--Human Genome Sciences (HGS: NASDAQ: HGSI) announced that BENLYSTA™ met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). These results show that BENLYSTA™ has the potential to become the first new approved drug in decades giving hope to people living with systemic lupus. DSG supports HGS on four global Phase 3 studies concurrently, providing data capture and supporting data management through its function rich eCaseLink™ EDC software.
“Our clinical trial data management and collection process is essential in a large and complex Phase 3 trial. DSG’s technology leadership and project management ensured that our subject data was accurate, complete and timely,” said Pierre Verroye, Executive Director of Clinical Data Management and Clinical Programming, HGS. “This was our first experience with EDC and DSG really helped lead the way. During the live study, DSG solved emerging, unprecedented challenges through innovation and by adding completely new functionality to HGS’ system. Sites and CRAs gave us a lot of positive feedback about the eCaseLink™ system.”
The study included nearly 400 electronic case report forms per subject, which were highly complex in design and had nearly 1,200 edits per screen. DSG provided critical data reporting tools based on study requirements, allowing HGS data management personnel to continually monitor and efficiently insure data quality.
HGS used DSG’s proprietary Data Management Dashboard within eCaseLink™ to rapidly identify any outstanding items needing attention during the global database lockdown. The DM Dashboard, developed with HGS to fill their unique needs won the 2008 Society for Clinical Data Management (SCDM) Data Driven Innovation Award and is now an integral part of DSG’s eCaseLink™ product.
DSG software allowed HGS to integrate a licensed Clinical Trial Management System (CTMS), and a third-party Interactive Voice Response System (IVRS) with eCaseLink™, ensuring an efficient and timely exchange of critical information.
“We are extremely pleased and excited to hear that HGS continues to make headway toward controlling SLE and has placed its faith in the technology and experience of DSG. We feel very proud not only being associated with this success but also for being a critical part of its success,” said Tony Varano, CEO, DSG, Inc. “DSG currently supports HGS with our global experience and presence on four Phase 3 studies concurrently with eCaseLink™ software. It’s very satisfying to solve such a complex problem with such a high level of technological sophistication and support service. The end result is a database lock that went very well and according to plan.”
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, the Lupus Research Institute at www.lupusresearchinstitute.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or Lupus Europe at www.elef.rheumanet.org.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer. For more information about HGS, please visit the company’s Web site at www.hgsi.com.
This has been one of my favorites for awhile after learning about Craig Venter and Sequencing the Human Genome. Craig partnered with Human Genome Sciences but you can learn more by reading Craig Venters A Life Decoded Biography which shows the ups and downs a scientist can have especially when dealing with the Government and the Human Genome Project.
Wikipedia on Human Genome Sciences. The company was founded by William A. Haseltine, a noted Harvard professor and AIDS researcher. HGS had a partnership for several years after its founding with Craig Venter and his non-profit TIGR to begin sequencing and submitting patents on hundreds of thousands of protein-encoding DNA fragments. In 2000, Haseltine said that his work "speeds up biological discovery a hundredfold, easily." He talked of finding in genes "the fountain of youth" in the form of "cellular replacement" therapies. More than $2 billion in investments was raised by the company by 1999-2000. Two initial drugs failed in clinical trials, and the stock share price declined from its highs. For example, in September 2000, the company reported that it had found a way to treat large, painful sores that often plague elderly patients, using a protein spray called repifermin, made by a human gene called keratinocyte growth factor-2. In February 2004, the company said that it was ending the development of repifermin because it showed no more benefit than a placebo in clinical trials.
On 7/20/09, Human Genome Sciences (NASDAQ:HGSI) and GlaxoSmithKline (NYSE:GSK) announced that Benlysta (belimumab, formerly LymphoStat-B) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo groups. Assuming positive results in November 2009 from a second Phase 3 trial of Benlysta, the companies plan to submit marketing applications in the United States, Europe, and other regions during 1H10.
Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups. "The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010." Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. No new drug for lupus has been approved by regulatory authorities in more than 50 years. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.
"Lupus is a chronic, often debilitating, and sometimes fatal illness that affects an estimated five million people worldwide and can have a devastating effect on both patients living with the disease and their families," said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. "BENLYSTA is the first medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially important therapeutic advance to patients suffering from SLE."
Key Findings from BLISS-52
"The BLISS-52 results support and extend the findings that emerged in the serologically active subgroup of SLE patients at Week 52 in our Phase 2 trial," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We are delighted to report that the efficacy of treatment with BENLYSTA plus standard of care was superior in this study to that of placebo plus standard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including SELENA SLEDAI and Physician's Global Assessment. Of note, a greater percentage of patients receiving BENLYSTA achieved a clinically meaningful reduction in steroid dose. We hope to have a full presentation of BLISS-52 results at an appropriate scientific meeting later in 2009."
About the BENLYSTA (belimumab) Phase 3 Development Program
The Phase 3 development program for belimumab includes two double-blind, placebo-controlled, multi-center Phase 3 superiority trials - BLISS-52 and BLISS-76 - to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care, in serologically active (i.e., autoantibody-positive) patients with SLE. This is the largest clinical trial program ever conducted in lupus patients. BLISS-52 randomized and treated 865 patients at 90 clinical sites in 13 countries, primarily in Asia, South America and Eastern Europe. BLISS-76 enrolled and randomized 826 patients at 133 clinical sites in 19 countries, primarily in North America and Europe. The design of the two trials is similar, but the duration of therapy in the two studies is different - 52 weeks for BLISS-52 and 76 weeks for BLISS-76. The data from BLISS-76 will be analyzed after 52 weeks in support of a potential Biologics License Application in the United States and Marketing Authorization Application in Europe and other regions. HGS designed the Phase 3 program for belimumab in collaboration with GSK and leading international SLE experts, and the program is being conducted under a Special Protocol Assessment agreement with FDA.
The primary efficacy endpoint of BLISS-52 and BLISS-76 is the patient response rate at Week 52, as defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician's Global Assessment (worsening defined as an increase of 0.30 points or more from baseline); and (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity). Analysis for the primary endpoint is based on intention-to-treat (ITT) and adjusted for baseline stratification factors, including SELENA SLEDAI score, proteinuria and race.
In each of the two Phase 3 trials, patients were randomized to one of three treatment groups: 10 mg/kg belimumab (BLISS-52, n=290), 1 mg/kg belimumab (BLISS-52, n=288), or placebo (BLISS-52, n=287). Patients are dosed intravenously on Days 0, 14 and 28, then every 28 days thereafter for the duration of the study. All receive standard of care therapy in addition to the study medication. Safety is reviewed by an independent Data Monitoring Committee throughout both studies.
About BENLYSTA (belimumab)
Belimumab is an investigational human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS(R). BLyS is a naturally occurring protein discovered by HGS that is required for the development of B-lymphocyte cells into mature plasma B cells. Plasma B cells produce antibodies, the body's first line of defense against infection. In lupus and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies - antibodies that attack and destroy the body's own healthy tissues. The presence of autoantibodies appears to correlate with disease severity. Preclinical and clinical studies suggest that belimumab can reduce autoantibody levels in SLE. BLISS 52 results suggest that belimumab can reduce SLE disease activity, and a second Phase 3 trial, BLISS-76, is underway to confirm these results.
About the Collaboration with GSK
In August 2006, HGS and GSK entered into a definitive co-development and co-commercialization agreement under which HGS has responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies will share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
About Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a chronic, life-threatening autoimmune disease. Approximately five million people worldwide, including approximately 1.5 million in the United States, suffer from various forms of lupus, including SLE. Lupus can occur at any age, but appears mostly in young people ages 15 to 45. About 90 percent of those diagnosed with lupus are women. African-American women are about three times more likely to develop lupus, and it is also more common in Hispanic, Asian and American Indian women. Symptoms may include extreme fatigue, painful and swollen joints, unexplained fever, skin rash and kidney problems. Lupus can lead to arthritis, kidney failure, heart and lung inflammation, central nervous system abnormalities, inflammation of the blood vessels and blood disorders. For more information on lupus, visit the Lupus Foundation of America at www.lupus.org, the Lupus Research Institute at www.lupusresearchinstitute.org, the National Institute of Arthritis and Musculoskeletal and Skin Diseases at www.niams.nih.gov, or Lupus Europe at www.elef.rheumanet.org.
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