Human Genome Sciences Announces Selection of Lymphostat-B(TM) for Participation in FDA's Continuous Marketing Application Pilot 2 Program
Thursday, March 4, 2004 08:32 AM ET Printer-friendly version
ROCKVILLE, Md., March 4 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI, news) announced today that the U.S. Food and Drug Administration (FDA) has selected LymphoStat-B™ for the treatment of systemic lupus erythematosus for inclusion in the Continuous Marketing Application (CMA) Pilot 2 Program. Participation in the Pilot 2 Program is limited to one product for each review division within the Center for Drug Evaluation and Research (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 Therapeutic Biological Internal Medicine Products.
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Human Genome Sciences currently is conducting a Phase 2 clinical trial to determine the safety and efficacy of LymphoStat-B in patients with active systemic lupus erythematosus.(1) LymphoStat-B also is in Phase 2 clinical trials in patients with rheumatoid arthritis.(2) In April 2003, the FDA designated LymphoStat-B a Fast Track Product for the treatment of systemic lupus erythematosus.
The Pilot 2 Program provides for frequent scientific feedback and interactions based on a prospectively defined agreement between the FDA and participants. To be eligible for selection, drugs or biologics must have been designated as a Fast Track Product and have held an End of Phase 1 or equivalent meeting with the FDA. According to the FDA, selection of drugs or biologics for participation was based on the FDA's overall assessment of the potential value of enhanced interaction, emphasizing the potential public health benefit resulting from the development of the product; the likelihood that the concentrated scientific dialogue will facilitate the availability of a promising novel therapy; and the applicant's demonstration of commitment to product development. The CMA concept and the Pilot 2 program were outlined in the June 2002 reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA) and are intended to provide the FDA with important information regarding whether enhanced communication and feedback can improve the efficiency 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 treatment of systemic lupus erythematosus for participation in the Pilot 2 Program. Participation in this program will allow for even greater interaction with the FDA regarding LymphoStat-B's development. We believe that this initiative builds upon LymphoStat-B's Fast Track Product designation and an already positive and productive relationship with the FDA."
William A. Haseltine, Ph.D., Chairman and CEO, said, "As a family, autoimmune diseases such as lupus cause immense suffering to millions of patients worldwide. LymphoStat-B's participation in the Pilot 2 Program will potentially further speed and clarify the regulatory pathway, and may, in turn, help bring a much-needed targeted treatment option to patients suffering from lupus."
LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS. BLyS is a naturally occurring protein discovered by Human Genome Sciences that is required for the development of B-lymphocyte cells into mature plasma B cells.(3) Plasma B cells produce antibodies, the body's first line of defense against infection. Laboratory studies have indicated that higher than normal levels of BLyS may contribute to the pathogenesis of autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis. (4)(5)(6)(7) Autoimmune diseases are diseases in which the body is attacked by its own immune system.
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. Retrospective and prospective studies have shown elevated levels of BLyS in the blood of many patients with systemic lupus erythematosus, and in the blood and joint fluid of patients with rheumatoid arthritis. (8)(9)(10)(11)(12) The results of prospective studies also now show a significant correlation of elevated levels of BLyS with systemic lupus erythematosus disease activity.(13) LymphoStat-B acts by: (1) binding to BLyS, (2) inhibiting BLyS's stimulation of B-cell development, and (3) restoring the potential for autoantibody-producing B cells to undergo the normal process of apoptosis (programmed cell death). In vitro and in vivo preclinical studies show that LymphoStat-B can reverse the immune stimulatory effects of BLyS.(14)
Systemic lupus erythematosus is a serious, life-threatening disease. Between 200,000 and 500,000 people are diagnosed with systemic lupus erythematosus each year in the United States alone. The disease affects between 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 hgsi.com. For more information on lupus, rheumatoid arthritis, or autoimmune diseases, visit The Lupus Foundation of America at lupus.org, the Arthritis Foundation at arthritis.org, or the National Institute of Arthritis and Musculoskeletal and Skin Diseases at niams.nih.gov.
For additional information on Human Genome Sciences, please visit our web site at hgsi.com.
For more information on the clinical trials evaluating LymphoStat-B in lupus patients, visit clinicaltrials.gov. Health professionals or patients interested in inquiring about the LymphoStat- B trials or any other study involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, hgsi.com, or by calling (240) 314-4400, extension 3550.
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based protein and antibody drugs to patients.
HGS, Human Genome Sciences, BLyS, and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for 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 property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Footnotes:
(1) (HGSI Press Release) Human Genome Sciences Initiates Phase 2 Clinical
Trial Of LymphoStat-B™ For The Treatment Of Systemic Lupus
Erythematosus. September 25, 2003.
(2) (HGSI Press Release) Human Genome Sciences Initiates Phase 2 Clinical
Trial Of LymphoStat-B™ For The Treatment Of Rheumatoid Arthritis.
January 8, 2004.
(3) (HGSI Press Release) Human Genome Sciences Announces The Discovery Of
A Novel Immune Stimulant. July 8, 1999.
(4) TACI and BCMA are receptors for a TNF homologue implicated in B-cell
autoimmune disease. Gross JA, Johnston J, Mudri S, et al. Nature.
2000; 404: 995-999.
(5) Severe B cell hyperplasia and autoimmune disease in TALL-1 transgenic
mice. 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 with
autoimmune 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 and
collagen-induced arthritis in mice. Wang H, Marsters SA, Baker T, et
al. Nature Immunol. 2001; 2: 632-637.
(8) (HGSI Press Release) High Levels Of Blys Implicated In Lupus And
Rheumatoid Arthritis Patients. October 30, 2000.
(9) Cutting edge: A role for B lymphocyte stimulator in systemic lupus
erythematosus. Zhang J, Roschke V, Baker K, Kimberly R, et al. J
Immuno. 2001; 166:6-10.
(10) Elevated Serum B Lymphocyte Stimulator Levels in Patients with
Systemic 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? Carter RH. Arthritis &
Rheumatism April 2003; 48(4): 882-885.
(12) Local production of B lymphocyte stimulator and APRIL in arthritic
joints of patients with inflammatory arthritis. Tan S, Roschke V,
Perry JW, Arkfeld DG, Ehresmann GR, Migone T, Hilbert DM, and Stohl
W. Arthritis & Rheumatism April 2003; 48(4): 982-992.
(13) Biomarkers in SLE: The Hopkins lupus cohort. Petri M. Lupus
Foundation of America Biomarkers for the Assessment of Systemic Lupus
Erythematosus Meeting. March 2003.
(14) Characterization of a Human Monoclonal Antibody That Antagonizes B-
Lymphocyte Stimulator Bioactivities. Les Sekut, Bonnie Sturm, Carol
Poortman, Ruth Wager, Chen Zhang, Donara Abramian, Todd Riccobene,
Svetlana Sosnovtseva, Cynthia Sung, Viktor Roschke, Kevin P. Baker,
David M. Hilbert. American College of Rheumatology 2001 Annual
Meeting, Abstract 1377.
(15) (HGSI Press Release) Results Of Phase 1 Clinical Trial Demonstrate
That LymphoStat-B Is Safe And Biologically Active In Patients With
Systemic Lupus Erythematosus. April 21, 2003.
Source: Human Genome Sciences, Inc.
Contact: David C. Stump, M.D., Executive Vice President, Drug Development, +1-240-314-4400, Jerry Parrott, Vice President, Corporate Communications, +1-301-315-2777, or Kate de Santis, Director, Investor Relations, +1-301-251-6003, all of Human Genome Sciences, Inc.
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