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| HUMAN GENOME SCIENCES PROVIDES UPDATE OF COMPANY PROGRESS | |
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- Human Monoclonal Antibody To CCR5 For Treatment Of HIV/AIDS To Be Developed - - Financially Strong With $1.4 Billion In Cash And Equivalents - ROCKVILLE, Maryland – May 12, 2003 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today will inform approximately 150 financial analysts in New York that the company is advancing a number of its products to their next stage of clinical development in 2003, and expects to file two to three Investigational New Drug (IND) applications for novel compounds before the end of the year. In a separate press release issued earlier today, Human Genome Sciences announced that it has acquired an exclusive worldwide license for a fully human monoclonal antibody to the CCR5 receptor that the Company is developing for the treatment of HIV/AIDS.1 (A webcast of today’s Human Genome Sciences Annual Analyst and Investor Meeting may be accessed at www.hgsi.com.) William A. Haseltine, Ph.D., Chairman and Chief Executive Officer, said, “Today, we announced that we have acquired an exclusive worldwide license from Abgenix for CCR5 mAb, a human monoclonal antibody that targets the CCR5 receptor. The CCR5 receptor is among the most interesting and important biological targets for a new class of drugs that inhibit HIV viral entry. Human Genome Sciences generated CCR5 mAb using the Abgenix XenoMouse® technology. We plan to develop CCR5 mAb for the treatment of HIV/AIDS. We also recently announced positive results from a Phase 2 clinical trial of repifermin for the treatment of cancer therapy-induced mucositis and positive results from a Phase 1 clinical trial of LymphoStat-B for the treatment of systemic lupus erythematosus.2, 3 “In the second half of 2003, we look forward to achieving significant additional product milestones. We plan to initiate Phase 2 clinical trials of LymphoStat-B™ for the treatment of lupus and rheumatoid arthritis. We also plan to initiate a Phase 2 trial of Albutropin™ in adults and a Phase 1/2 trial of Albutropin in children with growth hormone deficiency.3, 4 We expect to report the results of clinical trials for a number of our products. We expect to advance two to three additional novel protein and antibody drugs to Phase 1 clinical trials. “In addition, we are pleased to report significant progress in other areas. We continue to expand our manufacturing and clinical development capabilities. We have established Human Genome Sciences Europe, with responsibility for our European clinical trials. We have achieved a moderation in the rate at which our research and development expenses have increased. We continue in our determination to conserve cash, and we believe that our cash reserves are sufficient to cover our operating expenses over the next several years.” During the meeting, Human Genome Sciences executives will highlight the following key points:
Human Genome Sciences to Develop Human Monoclonal Antibody to CCR5 Receptor for the Treatment of HIV/AIDS Abgenix, Inc. and Human Genome Sciences announced earlier today that Human Genome Sciences has acquired an exclusive worldwide license from Abgenix to develop and commercialize a fully human monoclonal antibody to the CCR5 receptor.1 CCR5 is a human chemokine receptor shown to be required for infection by human immunodeficiency virus (HIV), the cause of Acquired Immunodeficiency Syndrome (AIDS). Human Genome Sciences generated the CCR5 human monoclonal antibody (CCR5 mAb) using the Abgenix XenoMouse® technology. Under the terms of a 1999 agreement, which was amended in 2001, Human Genome Sciences will pay milestone payments and royalties to Abgenix if the CCR5 mAb is successfully developed and commercialized.9 CCR5 mAb is designed to bind to and block the CCR5 receptor and thereby prevent the entry of HIV into cells of the immune system. Results of preclinical studies to date show that CCR5 mAb specifically binds to the CCR5 receptor and is capable of neutralizing HIV replication in vitro. Additional preclinical studies are currently underway to support an IND application seeking clearance from the U.S. Food and Drug Administration (FDA) to begin Phase 1 clinical trials of CCR5 mAb for the treatment of HIV/AIDS. Update on Progress of Products in Clinical and Preclinical Development Craig A. Rosen, Ph.D., President, Research and Development, and David C. Stump, M.D., Senior Vice President, Drug Development, will report on the progress of a number of the Company’s drugs in clinical and preclinical development. Human Genome Sciences focuses its internal product development efforts on novel human protein and antibody drugs discovered through genomics-based research, and on new improved long-acting versions of existing protein drugs created using its proprietary albumin fusion technology. Human Genome Sciences relies on collaborations for the development of gene therapy products, small molecule drugs, and diagnostic products discovered using its genomics-based technology. Dr. Rosen said, “We currently have eight drugs in clinical trials, and we have identified two more drugs that we expect to enter into clinical trials within the next few months. Our partners have four additional drugs in clinical development that they discovered using our technology. We continue to make significant progress toward bringing new drugs to patients based on our expertise in genomics and our exclusive focus on developing human protein and antibody drugs.” ABthrax: In March 2003, Human Genome Sciences announced the discovery and development of ABthrax, a human monoclonal antibody drug that is effective in protecting against the lethal effects of anthrax in multiple experimental models in animals. A single dose of ABthrax increases survival significantly in both rabbit and non-human primate models of inhalational anthrax. The Company plans to develop ABthrax for use as a prophylactic and therapeutic drug to prevent and treat anthrax infections, and expects to file an IND application in the near future, seeking clearance from the FDA to begin clinical trials to evaluate the safety, tolerability, and pharmacology of ABthrax in healthy adults Dr. Rosen said, “We were able to make what we consider to be significant and rapid progress in the discovery and proof of efficacy of ABthrax because we have all of the relevant technology in house, including expertise in the creation of human monoclonal antibodies with desired medical properties, and antibody drug manufacturing capabilities. Multiple in vivo and in vitro preclinical studies demonstrate that ABthrax specifically recognizes and neutralizes protective antigen, which is the key facilitator in the progression of anthrax infection at the cellular level.6 A single dose of ABthrax increases survival significantly in both rabbit and non-human primate models of inhalational anthrax. Research has shown that protective antigen is a rational target of the toxin components that contribute to the pathogenesis of anthrax infection. By inhibiting protective antigen, the anthrax toxins are inhibited. We are preparing to submit an IND to the FDA to begin human safety trials, and we continue to explore funding and stockpiling arrangements with the U.S. government.” Repifermin: Repifermin (keratinocyte growth factor-2, KGF-2) is a novel human protein discovered by Human Genome Sciences that stimulates the repair of injured skin and mucosal tissues. Human Genome Sciences is developing repifermin as a potential treatment for chronic venous ulcers and cancer therapy-induced mucositis. In April 2003, Human Genome Sciences announced that Phase 2 clinical trial results demonstrate that systemically administered repifermin is well tolerated and shows efficacy in treating cancer therapy-induced mucositis. The Company plans to meet with the FDA, clinical investigators, and its partner, GlaxoSmithKline, to determine the best path forward for confirming the efficacy and safety of repifermin for this clinical indication. A second Phase 2 clinical trial of repifermin for the treatment of cancer therapy-induced mucositis was initiated in September 2001 and is ongoing.10 Based on data emerging from studies conducted in healthy volunteers, the ongoing clinical trial was amended to add a cohort of patients who will receive a new high dose of repifermin at 75 mcg/kg. A total of approximately 90 patients will be enrolled in the study, and it is anticipated that results will be available before the end of 2003. In late 2002, the Company completed randomization of 352 patients into a double-blind, placebo-controlled Phase 2b clinical trial of topically administered repifermin for the treatment of chronic venous ulcers.8 Human Genome Sciences expects to complete the treatment and follow-up phase of the Phase 2b protocol and to have results available before the end of 2003. LymphoStat-B: Human Genome Sciences is developing LymphoStat-B, a human monoclonal antibody to B-lymphocyte stimulator (BLySTM), as a potential treatment for patients with autoimmune diseases, such as systemic lupus erythematosus and rheumatoid arthritis. In April 2003, Human Genome Sciences announced results from a Phase 1 clinical trial of LymphoStat-B. The results demonstrate that LymphoStat-B is well tolerated and biologically active in patients with lupus. As expected based on preclinical research, results show that LymphoStat-B significantly reduces the levels of circulating B (CD 20) cells, the precursor cells to those that produce the body’s normal and abnormal antibodies. The Company has met with its clinical investigators and the FDA, and plans to advance LymphoStat-B to Phase 2 clinical trials in lupus soon. The Phase 2 study in patients with lupus will be designed as a placebo-controlled, double-blind trial to evaluate different doses of intravenously administered LymphoStat-B in approximately 300 patients. Primary endpoints of the trial will be safety, optimal dosing, scores on a disease activity scale (SELENA SLEDAI), and time to first disease flare. Human Genome Sciences also plans to initiate Phase 2 clinical trials of LymphoStat-B for the treatment of rheumatoid arthritis during the second half of 2003. The Phase 2 study in patients with rheumatoid arthritis will be designed as a placebo-controlled, double-blind trial to evaluate different doses of intravenously administered LymphoStat-B in approximately 200 rheumatoid arthritis patients who have failed at least one disease-modifying treatment. Primary endpoints of the trial will be safety, optimal dosing, and scores on a disease activity scale (ACR 20). Albutropin: Results from a Phase 1 clinical trial of Albutropin in adults with growth hormone deficiency were reported in October 2002. The Phase 1 results demonstrated that Albutropin is well tolerated and, as expected based on preclinical results, remains in the blood substantially longer than is reported for recombinant native human growth hormone. The Phase 1 results also showed that Albutropin is biologically active and capable of restoring levels of insulin-like growth factor-1, a robust surrogate marker for the biological activity of human growth hormone, to within the normal range in a dose-dependent manner. Human Genome Sciences plans in mid-2003 to initiate a Phase 2 clinical trial of Albutropin in adults with growth hormone deficiency and a Phase 1/2 clinical trial of Albutropin in children with growth hormone deficiency. LymphoRad 131: LymphoRad131 is a radioiodinated form of B-lymphocyte stimulator (BLyS), a novel human protein discovered by Human Genome Sciences. Data will be presented from ongoing Phase 1 clinical trials evaluating the safety and pharmacology of LymphoRad131 in patients with multiple myeloma and non-Hodgkin’s lymphoma.11 As expected based on preclinical studies, imaging data from patients administered LymphoRad131 to date show that the drug is targeting B cells and B-cell tumors. Enrollment is expected to continue throughout 2003 and into 2004. Dr. Stump said, “LymphoRad has the potential to treat a broad range of B-cell tumors, such as multiple myeloma and non-Hodgkin’s lymphoma. The data emerging from our clinical trials in patients with multiple myeloma and non-Hodgkin’s lymphoma are very encouraging. We look forward to continuing to evaluate LymphoRad’s potential in these indications.” Albuferon-alpha: At the end of 2002, Human Genome Sciences reported results from a Phase 1 clinical trial of Albuferon-alpha, which demonstrate that Albuferon-alpha is well tolerated, has a prolonged half-life, and is biologically active in adults with chronic hepatitis C. The Company is continuing to evaluate Albuferon-alpha at higher doses, in single-dose and repeat-dose cohorts, under an amended protocol designed to seek the maximum biological response that can be achieved at a tolerable dose. Human Genome Sciences continues to dose-escalate under the amended protocol, and interim data continue to demonstrate that Albuferon-alpha is well tolerated, has a prolonged half-life and is biologically active in patients with chronic hepatitis C. The Company is now working with the FDA to amend the protocol further to include interferon-alpha treatment-naive patients. BLyS: BLyS is a novel human protein discovered by Human Genome Sciences that is being developed as a potential treatment for patients with immunodeficiencies. Results from a Phase 1 clinical trial to evaluate the safety and pharmacology of BLyS in patients with common variable immunodeficiency were reported in January 2003. Results demonstrate that BLyS is safe and well-tolerated. BLyS also is the subject of an ongoing Phase 1 clinical trial, which the Company expects to complete before the end of 2003, to evaluate it for the treatment of an immune disorder known as immunoglobulin-A (IgA) deficiency.12
Albuleukin: Albuleukin is a novel long-acting form of interleukin-2 that the Company is developing as a potential treatment for a broad range of cancers. Human Genome Sciences is conducting Phase 1 clinical trials to evaluate the safety and pharmacology of Albuleukin in patients with solid tumor cancers, and expects enrollment in these trials to conclude by the end of 2003. Results are expected in 2004. TRAIL-R2 mAb: The TRAIL Receptor-2 protein was discovered by Human Genome Sciences. TRAIL Receptor-2 agonistic human monoclonal antibody (TRAIL-R2 mAb) specifically recognizes the TRAIL Receptor-2 protein, found on the surface of a number of solid tumor and hematopoietic cancer cells. Binding of TRAIL-R2 mAb to TRAIL Receptor-2 triggers programmed cell death, or apoptosis. Results of preclinical studies to date show that TRAIL-R2 mAb specifically binds to TRAIL Receptor-2, induces apoptosis, and has anti-tumor activity in a broad range of tumor types, both as a single agent and in combination with chemotherapy. Human Genome Sciences hopes to begin Phase 1 clinical trials to evaluate the safety and pharmacology of TRAIL-R2 mAb for the treatment of cancer during 2003. Albugon: Human Genome Sciences’ late-stage preclinical candidates include Albugon, a novel, long-acting form of GLP-1 that shows promise in preclinical studies for the treatment of Type 2 diabetes. GLP-1 is a human peptide that has been shown in preclinical and clinical research to lower blood glucose levels and to provide a therapeutic benefit for type 2 diabetes. However, GLP-1 has a very short half-life that has made it difficult to develop as a drug. Albugon was created by fusing the gene for human albumin to the gene for GLP-1. Results from preclinical studies to date demonstrate that Albugon is well tolerated, has a substantially longer half-life than the GLP-1 peptide, and is capable of controlling and increasing insulin production and reducing the need for insulin administration in experimental models of type 2 diabetes. Additional preclinical studies are underway to support an IND application seeking FDA clearance to being Phase 1 clinical trials. For additional information on Human Genome Sciences, please visit our web site at www.hgsi.com. Health professionals interested in clinical studies involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550. Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients. HGS, Human Genome Sciences, Albuferon, Albugon, Albuleukin, Albutropin, BLyS, LymphoRad and LymphoStat-B are trademarks of Human Genome Sciences, Inc. All other trademarks and trade names are the property of their respective owners. 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. # # #
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