|
|
| HUMAN GENOME SCIENCES REPORTS RESULTS OF CLINICAL TRIAL OF REPIFERMIN IN PATIENTS WITH CHRONIC VENOUS ULCERS | |
|
ROCKVILLE, Maryland -- September 25, 2003 -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today reported that a Phase 2 clinical trial of topically administered repifermin (keratinocyte growth factor-2, KGF-2) in adults with chronic venous ulcers did not meet its primary endpoint. Efficacy was measured in the trial as the percentage of patients achieving complete wound closure within 20 weeks of initiating treatment. The percentage of patients treated with repifermin at doses of 60 and 120 mcg per square centimeter of wound area who achieved complete wound closure within the 20-week timeframe was not statistically significantly different from placebo, nor was there any favorable trend for the repifermin-treated groups. The 352 patients who were randomized in the multi-center double-blind placebo-controlled trial had chronic venous ulcers from 3 to 25 square centimeters in size that had persisted unhealed for 3 to 36 months prior to enrollment. All patients received standardized compression therapy and wound care for the duration of the study. Repifermin was well tolerated with a safety profile similar to placebo. There also were no significant differences between repifermin and placebo on prespecified secondary endpoints of time to complete wound closure or complete wound closure by 16 or 26 weeks of treatment. David C. Stump, M.D., Senior Vice President, Drug Development, said, "Given the prior results with repifermin in this patient population, we are disappointed in the efficacy results from this study. We are especially disappointed for the many patients in need who could benefit from the availability of improved treatment options for this difficult medical problem. However, in my opinion, the level of evidence is now not sufficient to warrant our further development of repifermin for use in the treatment of chronic venous ulcers." Craig A. Rosen, Ph.D., President, Research and Development, said, "Obviously, we are disappointed in the results of the repifermin trial in chronic venous ulcers. However, Human Genome Sciences has an exceptionally rich development pipeline of novel clinical and advanced preclinical compounds, each of which has a sound biological rationale and addresses a major unmet medical need. The focus of our drug development program continues to be cancer and immunology." A Phase 2 trial of the use of repifermin for the treatment of cancer therapy-induced mucositis is still ongoing. For more information on repifermin, see www.hgsi.com/products/kgf2.html. For additional information on Human Genome Sciences, please visit our web site at www.hgsi.com. Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients. HGS and Human Genome Sciences 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.
CONTACTS: |