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| HUMAN GENOME SCIENCES REPORTS POSITIVE INTERIM RESULTS OF PHASE 2 TRIAL OF ALBUFERON IN COMBINATION WITH RIBAVIRIN IN TREATMENT-EXPERIENCED PATIENTS WITH CHRONIC HEPATITIS C | |
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- Results to date show Albuferon is safe, well tolerated and shows robust antiviral activity - - Interim data support further evaluation of higher dose levels with a 28-day administration schedule - - Conference call today at 10 AM Eastern - ROCKVILLE, Maryland – March 14, 2006 – Human Genome Sciences, Inc. (Nasdaq: HGSI ) today reported the interim results of a Phase 2 clinical trial to evaluate the safety, tolerability and efficacy of Albuferon™ (albumin-interferon alpha 2b) in combination with ribavirin in patients with chronic hepatitis C who failed to respond to previous interferon alpha-based treatment regimens. The results to date demonstrate that Albuferon in combination with ribavirin was safe, well tolerated and showed robust antiviral activity. A presentation of the full interim data will take place on April 30 at the European Association for the Study of the Liver (EASL). 1 In a separate press release issued today, HGS announced the interim results of a larger Phase 2b clinical trial of Albuferon in combination with ribavirin, versus Pegasys with ribavirin, in treatment-naïve patients with chronic hepatitis C genotype 1.2 David C. Stump, M.D., Executive Vice President, Drug Development, said, “I continue to be encouraged by the growing evidence that Albuferon in combination with ribavirin is safe and well tolerated, with robust and durable antiviral activity. The results available from the first three treatment groups for the 48-week treatment period of the Phase 2 study demonstrate that Albuferon was well tolerated at all doses administered, with no significant increase in severity of adverse events between Week 12, Week 24 and Week 48. Decreases in hematologic cell counts were well managed with dose reductions, and returned to baseline following the completion of therapy. I am also encouraged by the emerging evidence of clinically significant antiviral effect. At Week 48, 30% of the patients in the three lower-dose treatment groups had no detectable hepatitis C RNA viral load. At the 12-week follow-up point, 18% of the patients continued to have no detectable hepatitis C RNA viral load. These data are quite positive, considering that they were observed in a heavily pretreated population, nearly two thirds of whom previously failed to respond to treatment regimens that included pegylated interferon alpha plus ribavirin. “The results to date also indicate that both the 1500-mcg and the 1800-mcg doses were well tolerated, with safety data generally similar to the lower-dose treatment groups and with greater antiviral activity. Results at the higher doses in the current Phase 2 study encourage us to evaluate a regimen in interferon-naïve patients that combines higher doses of Albuferon with ribavirin administered at intervals of 28 days. We look forward to the complete presentation of these interim data at the EASL meeting in April, and to continuing the evaluation of Albuferon in combination with ribavirin at higher doses and over the full term of the current study.” The Phase 2 trial is a randomized, open-label, multi-center, dose-escalation study, and is being conducted in the United States . The study design states that approximately 50 percent of the subjects enrolled should be patients who have failed combination therapy that included pegylated interferon alpha plus ribavirin. A total of 115 patients have been enrolled into 5 Albuferon treatment groups that are receiving doses of Albuferon ranging from 900-1800 mcg.1, 3-5Patients were initially randomized into 3 Albuferon treatment groups (900 mcg at 14-day intervals, 1200 mcg at 14-day intervals, and 1200 mcg at 28-day intervals). Following evaluation of safety data, 2 additional cohorts were enrolled sequentially (1500 mcg at 14-day intervals and 1800 mcg at 14-day intervals). Patients are receiving Albuferon administered subcutaneously, with all patients receiving weight-based oral ribavirin daily at 1000 or 1200 mg in two divided doses. Patients in the trial will receive 48 weeks of treatment, with an additional 24 weeks of follow-up. The primary objective of the Phase 2 study is to evaluate the safety and tolerability of Albuferon in combination with ribavirin. The study also is evaluating the efficacy of Albuferon in combination with ribavirin. The primary efficacy endpoint is sustained virologic response ( SVR ), defined as undetectable virus 24 weeks after the end of therapy. Data are available through Week 48 (end of treatment) on 71 patients who were enrolled in parallel and randomized into three Albuferon treatment groups: 900 mcg administered subcutaneously every 14 days, 1200 mcg administered subcutaneously every 14 days, and 1200 mcg administered subcutaneously every 28 days – with all patients receiving weight-based oral ribavirin daily at 1000 or 1200 mg in two divided doses. Of the subjects in the first three Albuferon treatment groups, 65% (46/71) were non-responders to pegylated interferon alpha, and 93% (66/71) were infected with genotype 1 hepatitis C. More than 60% of the study subjects had received more than one prior interferon alpha-based treatment regimen, and the mean duration of prior therapy was approximately 15 months. At Week 48, 30% (21/71) of the patients exhibited no detectable HCV RNA viral load. Antiviral activity was similar for the 14-day and 28-day Albuferon treatment groups. At the Week 12 follow-up after the end of treatment, 18% (13/71) of these heavily pretreated patients had no detectable hepatitis C RNA viral load. Albuferon in combination with ribavirin was well tolerated. The incidence of adverse events was similar across the three dose groups for which 48-week data are available, and generally similar to the adverse events observed in the 2 higher-dose groups (24-Week data for the 1800-mcg and 1500-mcg cohorts). There was no increase in severity of adverse events beyond Week 12. Hematologic reductions were maximal by Week 8, were well managed with dose reductions, and returned to baseline following the completion of therapy (Week 12 follow-up after the end of 48 weeks of treatment). Albuferon appeared to be better tolerated in the treatment group receiving 1200 mcg administered subcutaneously every 28 days, with fewer hematologic dose reductions observed in this group. No subject required discontinuation of either Albuferon or ribavirin for hematological abnormalities. Overall, the rate of treatment-emergent Albuferon antibodies is 10%, with pre-existing antibodies detected in 17% of study participants. There was no apparent correlation between the emergence of antibodies and antiviral response, adverse events or pharmacokinetics. No overall increase in the emergence of antibodies was observed between Week 12, Week 24 and Week 48, or in administration of higher doses. Data are available through Week 24 for treatment groups receiving, in combination with ribavirin, Albuferon doses of 1500 mcg and 1800 mcg, respectively, administered subcutaneously every 14 days. At Week 24, the same percentage of patients in the 1500-mcg and 1800-mcg Albuferon treatment groups exhibited no detectable hepatitis C RNA viral load: 32% (7/22) in each of the two groups. Data also are available for the 1500-mcg and 1800-mcg Albuferon treatment groups on early virologic response (EVR12). EVR12 is defined as a >2 log (99% or greater) reduction in HCV RNA viral load at Week 12. In the 1500-mcg treatment group, 41% or the patients (9/22) achieved EVR12. In the 1800-mcg treatment group, 59% (13/22) of the patients achieved EVR12. The 1800-mcg Albuferon treatment group had a higher percentage of genotype 1 hepatitis C patients who had failed to respond to previous treatment with a combination of pegylated interferon and ribavirin – 91% (20/22) versus an average of 66% (61/93) in the other Albuferon treatment groups combined. At Week 24 in this important and most difficult to treat subgroup, the data show the following percentages of patients with no detectable HCV RNA viral load: 17% (2/12) in the treatment group receiving 900 mcg of Albuferon at 14-day intervals; 19% (3/16) in the treatment group receiving 1200 mcg of Albuferon at 14-day intervals; 15% (2/13) receiving 1200 mcg of Albuferon at 28-day intervals; 27% (4/15) receiving 1500 mcg of Albuferon at 14-day intervals; and 32% (6/19) receiving 1800 mcg of Albuferon at 14-day intervals. Data also are available for this subgroup on early virologic response (EVR12). The data show the following percentages of patients achieving EVR12: 42% (5/12) in the treatment group receiving 900 mcg of Albuferon at 14-day intervals; 25% (4/16) receiving 1200 mcg of Albuferon at 14-day intervals; 23% (3/13) in the treatment group receiving 1200 mcg of Albuferon at 28-day intervals; 33% (5/15) receiving 1500 mcg of Albuferon at 14-day intervals; and 63% (12/19) receiving 1800 mcg of Albuferon at 14-day intervals. Safety data available for the 1500-mcg and 1800-mcg treatment groups through Week 24 are generally similar to the lower-dose Albuferon treatment groups. No increase in the emergence of Albuferon antibodies was observed related to administration of the higher doses. Albuferon is a novel, long-acting form of interferon alpha. It is a Human Genome Sciences drug made possible by the company’s proprietary albumin fusion technology, which was used to improve the pharmacological properties 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 is developing Albuferon for use in the treatment of chronic hepatitis C. Hepatitis C infection 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. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly 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. CONFERENCE CALL HGS management will hold a conference call to discuss this announcement today at 10:00 am Eastern Time. Investors may listen to the call by dialing 866/564-7439 or 719/785-9449, passcode 2094807, five to ten minutes before the start of the call. A replay of the conference call will be available for several days by dialing 888/203-1112 or 719/457-0820, passcode 2094807. This conference call also will be webcast. Interested parties who wish to listen to the webcast should visit the Human Genome Sciences web site at www.hgsi.com . The archive of the conference call will be available several hours after the conference call and will remain available for several days. Human Genome Sciences is a company with the mission to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs. 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 company’s web site, www.hgsi.com/products/request.html, or by calling (301) 610-5790, extension 3550. 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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