Human Genome Sciences Lupus Drug looks promising
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
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.
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.
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.