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| HUMAN GENOME SCIENCES REPORTS POSITIVE RESULTS OF PHASE 2 CLINICAL TRIAL OF ALBUFERON® IN TREATMENT-NAÏVE PATIENTS WITH CHRONIC HEPATITIS C | |
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- Mean reduction in HCV viral load of 3.2 log at Day 28 observed in the combined 900 mcg and 1200 mcg dose cohorts - ROCKVILLE, Maryland – April 14, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced the results of a Phase 2 clinical trial of Albuferon™ (albumin-interferon alpha) in patients with chronic hepatitis C who are naïve to interferon-alpha treatments. The results demonstrate that Albuferon is well tolerated, has a prolonged half-life and shows robust antiviral activity, with durable dose-dependent reductions in hepatitis C viral load. The data were presented today in Paris at the 40th Annual Meeting of the European Association for the Study of the Liver (EASL) in an oral presentation entitled, “A Phase 2 Study to Assess Antiviral Response, Safety, and Pharmacokinetics of Albuferon in IFNa -Naïve Subjects with Genotype 1 Chronic Hepatitis C.”1 The Phase 2 trial, which was conducted in Canada, was a randomized, open-label, multi-center, parallel-design, dose-ranging study to evaluate the safety, tolerability, pharmacology and optimal dosing of Albuferon.2-3 A total of 56 patients were enrolled in the trial and randomized to 5 dose groups (200 mcg, 450 mcg, 670 mcg, 900 mcg and 1200 mcg).4 Patients were given 2 doses of Albuferon monotherapy administered subcutaneously 14 days apart and were followed for safety and antiviral evaluations for a total of 6 weeks. The pharmacodynamic activity of Albuferon was evaluated based on hepatitis C (HCV) RNA viral load reductions over a 42-day period of exposure. One of the study objectives was to identify a range of active doses that Human Genome Sciences plans to evaluate in a larger 48-week study of Albuferon in combination with ribavirin in patients with HCV genotype 1 who are naïve to interferon treatments. The primary efficacy endpoint of the Phase 2 study was the rate of virologic response at Day 28, defined as at least a 2-log reduction in HCV viral load compared with baseline, or undetectable HCV viral load. The data presented show that Albuferon exhibited robust antiviral activity in genotype 1 HCV. A mean reduction in HCV viral load of 3.2 log at Day 28 was observed in the combined 900 mcg and 1200 mcg dose cohorts, with 69% of patients (18/26) in these cohorts showing a >2-log reduction in HCV viral load at Day 28. Undetectable viral load was observed at Day 42 (28 days after the second injection) in 23% of patients (6/26) in the combined 900 mcg and 1200 mcg dose cohorts. Robust dose-dependent viral kinetics were observed, with the majority of patients in the 900 mcg and 1200 mcg cohorts exhibiting a second-phase decline in viral load of >0.3 log per week, which has previously been shown to be predictive of sustained virologic response (SVR) in treatment with the pegylated interferons.5 Reductions in viral load of > 2 log are reported in approximately 42% of genotype 1 HCV patients treated with pegylated interferon alpha products in combination with ribavirin.6 Consistent with clinical results to date7-8, the results presented at EASL demonstrate that Albuferon remained in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha. Albuferon was detectable for up to 4 weeks following the second subcutaneous injection. The Cmax (peak drug level) increases in a linear manner over the dose range evaluated (200-1200 mcg). Albuferon exhibited a median half-life of 148 hours, supporting dosing at intervals of 2-4 weeks. This compares to a reported mean (range) elimination half-life of 80 hours (50-140 hours) for Pegasys and 40 hours (22-60 hours) for PEG-Intron.9-10 The Phase 2 clinical trial results demonstrate that Albuferon was well tolerated with adverse events that were transient and mostly mild to moderate in severity. One serious adverse event was reported (acute colitis) and has subsequently resolved. There were no discontinuations due to reductions in hematologic cell counts. No subjects developed newly emergent antibodies to alpha interferon. One subject developed low-titer antibodies to human serum albumin. There was no apparent correlation between the emergence of antibodies and adverse events, antiviral response or pharmacokinetics. Vincent Bain, M.D., Director of the Liver Unit and Professor of Gastroenterology, University of Alberta, said, “While therapies currently available for the treatment of chronic hepatitis C are effective, approximately half of genotype 1 patients fail to achieve sustained virologic response following treatment with regimens that include pegylated interferons. In addition, these therapies are frequently associated with side effects that require dose adjustments and may even require discontinuation of treatment. Most patients currently receive pegylated interferon once weekly, with daily doses of ribavirin. A significant need exists for more convenient treatment options with fewer side effects. The clinical results presented at the EASL meeting today show that Albuferon is well tolerated and exhibits a robust antiviral activity, with a pharmacokinetic profile that supports dosing at intervals of two to four weeks. These data are strongly supportive of further evaluation of Albuferon in combination with ribavirin in a larger study over a longer period of time in treatment-naïve patients.” David C. Stump, M.D., Executive Vice President, Drug Development, said, “The results of the current Phase 2 trial will inform our identification of an optimal range of doses to evaluate in a larger 48-week combination study of Albuferon with ribavirin that we plan to conduct in treatment-naïve patients. These data, along with the preliminary results emerging from our ongoing Phase 2 combination study in treatment-experienced patients3, 11, afford confidence in the ability to administer Albuferon actively and safely in combination with ribavirin to treatment-naïve patients. We look forward to continuing our development of Albuferon as a potential treatment for chronic hepatitis C.” Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world, and afflicts approximately four million people in the United States. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. Intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C. The current standard of care for treating chronic hepatitis C is combination therapy consisting of pegylated interferon and ribavirin, an antiviral drug.6, 9-10, 12-17 Albuferon is a novel, long-acting form of interferon alpha. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers. Human Genome Sciences modified interferon alpha to improve its pharmacological properties by using the company’s proprietary albumin fusion technology. For more information about Albuferon, see www.hgsi.com/products/albuferon.html. Health professionals interested in more information about trials involving Human Genome Sciences 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 (301) 610-5790, 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 and Albuferon 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:
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