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Human Genome Sciences Announces Selection of Lymphostat-B for Participation in FDA's Continuous Marketing Application Pilot 2 Program

ROCKVILLE, Md., March 4 /PRNewswire-FirstCall/ -- Human Genome Sciences,Inc. (Nasdaq: HGSI) announced today that the U.S. Food and Drug Administration(FDA) has selected LymphoStat-B for the treatment of systemic lupuserythematosus for inclusion in the Continuous Marketing Application (CMA)Pilot 2 Program. Participation in the Pilot 2 Program is limited to oneproduct for each review division within the Center for Drug Evaluation andResearch (CDER) and the Center for Biologics Evaluation and Research (CBER).LymphoStat-B (human monoclonal antibody to B-lymphocyte stimulator, BLyS)is the product selected for participation by CDER's Division of TherapeuticBiological Internal Medicine Products.(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )Human Genome Sciences currently is conducting a Phase 2 clinical trial todetermine the safety and efficacy of LymphoStat-B in patients with activesystemic lupus erythematosus.(1) LymphoStat-B also is in Phase 2 clinicaltrials in patients with rheumatoid arthritis.(2) In April 2003, the FDAdesignated LymphoStat-B a Fast Track Product for the treatment of systemiclupus erythematosus.The Pilot 2 Program provides for frequent scientific feedback andinteractions based on a prospectively defined agreement between the FDA andparticipants. To be eligible for selection, drugs or biologics must have beendesignated as a Fast Track Product and have held an End of Phase 1 orequivalent meeting with the FDA. According to the FDA, selection of drugs orbiologics for participation was based on the FDA's overall assessment of thepotential value of enhanced interaction, emphasizing the potential publichealth benefit resulting from the development of the product; the likelihoodthat the concentrated scientific dialogue will facilitate the availability ofa promising novel therapy; and the applicant's demonstration of commitment toproduct development. The CMA concept and the Pilot 2 program were outlined inthe June 2002 reauthorization of the Prescription Drug User Fee Act of 1992(PDUFA) and are intended to provide the FDA with important informationregarding whether enhanced communication and feedback can improve theefficiency of the drug development and review process and shorten review time.Sally D. Bolmer, Ph.D., R.A.C., Senior Vice President, Regulatory Affairs,said, "We are honored by the FDA's selection of LymphoStat-B for the treatmentof systemic lupus erythematosus for participation in the Pilot 2 Program.Participation in this program will allow for even greater interaction with theFDA regarding LymphoStat-B's development. We believe that this initiativebuilds upon LymphoStat-B's Fast Track Product designation and an alreadypositive and productive relationship with the FDA." A. Haseltine, Ph.D., Chairman and CEO, said, "As a family,autoimmune diseases such as lupus cause immense suffering to millions ofpatients worldwide. LymphoStat-B's participation in the Pilot 2 Program willpotentially further speed and clarify the regulatory pathway, and may, inturn, help bring a much-needed targeted treatment option to patients sufferingfrom lupus."LymphoStat-B is a human monoclonal antibody that specifically recognizesand inhibits the biological activity of B-lymphocyte stimulator, or BLyS.BLyS is a naturally occurring protein discovered by Human Genome Sciences thatis required for the development of B-lymphocyte cells into mature plasma Bcells.(3) Plasma B cells produce antibodies, the body's first line of defenseagainst infection. Laboratory studies have indicated that higher than normallevels of BLyS may contribute to the pathogenesis of autoimmune diseases, suchas systemic lupus erythematosus and rheumatoid arthritis. (4)(5)(6)(7)Autoimmune diseases are diseases in which the body is attacked by its ownimmune system.In lupus, rheumatoid arthritis, and certain other autoimmune diseases,elevated levels of BLyS are believed to contribute to the production ofautoantibodies -- antibodies that attack and destroy the body's own healthytissues. Retrospective and prospective studies have shown elevated levels ofBLyS in the blood of many patients with systemic lupus erythematosus, and inthe blood and joint fluid of patients with rheumatoid arthritis.(8)(9)(10)(11)(12) The results of prospective studies also now show asignificant correlation of elevated levels of BLyS with systemic lupuserythematosus disease activity.(13) LymphoStat-B acts by: (1) binding toBLyS, (2) inhibiting BLyS's stimulation of B-cell development, and (3)restoring the potential for autoantibody-producing B cells to undergo thenormal process of apoptosis (programmed cell death). In vitro and in vivopreclinical studies show that LymphoStat-B can reverse the immune stimulatoryeffects of BLyS.(14)Systemic lupus erythematosus is a serious, life-threatening disease.Between 200,000 and 500,000 people are diagnosed with systemic lupuserythematosus each year in the United States alone. The disease affectsbetween eight and ten times as many women as men. It can occur at any age,but appears mostly in young people between the ages of fifteen and forty-five.For more information on LymphoStat-B, see http://www.hgsi.com/products/LSB.html.For more information on lupus, rheumatoid arthritis, or autoimmune diseases,visit The Lupus Foundation of America at http://www.lupus.org, the ArthritisFoundation at http://www.arthritis.org, or the National Institute of Arthritis andMusculoskeletal and Skin Diseases at http://www.niams.nih.gov.For additional information on Human Genome Sciences, please visit our website at http://www.hgsi.com.For more information on the clinical trials evaluating LymphoStat-B inlupus patients, visit http://www.clinicaltrials.gov/ct/show/NCT00071487.Health professionals or patients interested in inquiring about the LymphoStat-B trials or any other study involving HGSI products are encouraged to inquirevia the Contact Us section of the Human Genome Sciences web site,http://www.hgsi.com/products/request.html, or by calling , extension3550.

Human Genome Sciences is a company with the mission to treat and curedisease by bringing new gene-based protein and antibody drugs to patients.

HGS, Human Genome Sciences, BLyS, and LymphoStat-B are trademarks of HumanGenome Sciences, Inc.

This announcement contains forward-looking statements within the meaningof Section 27A of the Securities Act of 1933, as amended, and Section 21E ofthe Securities Exchange Act of 1934, as amended. The forward-lookingstatements are based on Human Genome Sciences' current intent, belief andexpectations. These statements are not guarantees of future performance andare subject to certain risks and uncertainties that are difficult to predict.Actual results may differ materially from these forward-looking statementsbecause of the Company's unproven business model, its dependence on newtechnologies, the uncertainty and timing of clinical trials, the Company'sability to develop and commercialize products, its dependence on collaboratorsfor services and revenue, its substantial indebtedness and lease obligations,its changing requirements and costs associated with planned facilities,intense competition, the uncertainty of patent and intellectual propertyprotection, the Company's dependence on key management and key suppliers, theuncertainty of regulation of products, the impact of future alliances ortransactions and other risks described in the Company's filings with theSecurities and Exchange Commission. Existing and prospective investors arecautioned not to place undue reliance on these forward-looking statements,which speak only as of today's date. Human Genome Sciences undertakes noobligation to update or revise the information contained in this announcementwhether as a result of new information, future events or circumstances orotherwise.

Footnotes:

(1) (HGSI Press Release) Human Genome Sciences Initiates Phase 2 ClinicalTrial Of LymphoStat-B For The Treatment Of Systemic LupusErythematosus. September 25, 2003.

(2) (HGSI Press Release) Human Genome Sciences Initiates Phase 2 ClinicalTrial Of LymphoStat-B For The Treatment Of Rheumatoid Arthritis.January 8, 2004.

(3) (HGSI Press Release) Human Genome Sciences Announces The Discovery OfA Novel Immune Stimulant. July 8, 1999.

(4) TACI and BCMA are receptors for a TNF homologue implicated in B-cellautoimmune disease. Gross JA, ston J, Mudri S, et al. Nature.2000; 404: 995-999.

(5) Severe B cell hyperplasia and autoimmune disease in TALL-1 transgenicmice. Khare S.D., Saarosi I, Xia XZ, et al. Proc Natl Acad Sci USA.2000; 97: 3370-3375.

(6) Mice transgenic for BAFF develop lymphocytic disorders along withautoimmune manifestations. MacKay F., Woodcock SA, Lawton P, et al.J. Exp. Med. 1999; 190: 1697-1710.

(7) TACI-ligand interactions are required for T cell activation andcollagen-induced arthritis in mice. Wang H, Marsters SA, Baker T, etal. Nature Immunol. 2001; 2: 632-637.

(8) (HGSI Press Release) High Levels Of Blys Implicated In Lupus AndRheumatoid Arthritis Patients. October 30, 2000.

(9) Cutting edge: A role for B lymphocyte stimulator in systemic lupuserythematosus. Zhang J, Roschke V, Baker K, R, et al. JImmuno. 2001; 166:6-10.

(10) Elevated Serum B Lymphocyte Stimulator Levels in Patients withSystemic Immune-Based Rheumatic Diseases. Cheema GS, Roschke V,Hilbert DM and Stohl W. Arthritis & Rheumatism June 2001; 44(6):1313-1319.

(11) A role for BLyS in tissue inflammation? RH. Arthritis & Rheumatism April 2003; 48(4): 882-885.

(12) Local production of B lymphocyte stimulator and APRIL in arthriticjoints of patients with inflammatory arthritis. Tan S, Roschke V, JW, Arkfeld DG, Ehresmann GR, Migone T, Hilbert DM, and StohlW. Arthritis & Rheumatism April 2003; 48(4): 982-992.

(13) Biomarkers in SLE: The Hopkins lupus cohort. Petri M. LupusFoundation of America Biomarkers for the Assessment of Systemic LupusErythematosus Meeting. March 2003.

(14) Characterization of a Human Monoclonal Antibody That Antagonizes B-Lymphocyte Stimulator Bioactivities. Les Sekut, Bonnie Sturm, CarolPoortman, Ruth Wager, Chen Zhang, Donara Abramian, Todd Riccobene,Svetlana Sosnovtseva, Sung, Viktor Roschke, P. Baker, M. Hilbert. American College of Rheumatology 2001 AnnualMeeting, Abstract 1377.

(15) (HGSI Press Release) Results Of Phase 1 Clinical Trial DemonstrateThat LymphoStat-B Is Safe And Biologically Active In Patients WithSystemic Lupus Erythematosus. April 21, 2003.

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[Guest guest]

ya and I was denied it - go figure!!!

My rhuemy still doesn't understand how and why I was denied it - He

is going to fight it.

Like I told - I was probably denied because it actually pays

YOU the lupus patient $40.00 per visit so anything that would make me

money I will automatically be denied just because of my luck...

Oh well

[Guest guest]

Where do you sign up for the Lupus Research Study?

Blessings,

> ya and I was denied it - go figure!!!

>

> My rhuemy still doesn't understand how and why I was denied it - He

> is going to fight it.

>

> Like I told - I was probably denied because it actually pays

> YOU the lupus patient $40.00 per visit so anything that would make

me

> money I will automatically be denied just because of my luck...

>

> Oh well

[Guest guest]

Wonder if it's because your not a patient of the AAIR? I am, that's why they sent me the letter.