|
|
| HUMAN GENOME SCIENCES COMPLETES ENROLLMENT IN A PHASE 2 CLINICAL TRIAL OF ALBUFERON IN TREATMENT-NAÏVE PATIENTS WITH CHRONIC HEPATITIS C | |
|
- Preliminary data demonstrate sufficient antiviral activity to support larger Phase 2b study in combination with ribavirin in treatment-naïve patients -
ROCKVILLE, Maryland – February 16, 2005 – Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that it has completed enrollment, randomization and dosing in a Phase 2 clinical trial of Albuferon™ (albumin-interferon alpha) in patients with chronic hepatitis C who are naïve to interferon-alpha treatments. The Phase 2 trial, which is being conducted in Canada, is a randomized, open-label, multi-center, parallel-design, dose-ranging study to evaluate the safety, tolerability, pharmacology, and optimal dosing of Albuferon. 1 A total of 56 patients with hepatitis C virus (HCV) genotype 1 have been enrolled in the trial and randomized to five dose groups. Patients are being given two doses of Albuferon administered subcutaneously fourteen days apart. The pharmacodynamic activity of Albuferon is being evaluated based on HCV RNA viral load reductions over a 28-day period of exposure. One of the study objectives is 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. Preliminary data are available from 38 patients who have completed more than 28 days of the ongoing Phase 2 study, including 30 patients enrolled in the 200 mcg, 450 mcg and 670 mcg dose cohorts, and 8 patients enrolled in the 900 mcg and 1200 mcg dose cohorts. 2 The available data demonstrate that Albuferon is well tolerated with demonstration of antiviral activity in genotype 1 HCV. A reduction in viral load of > 2 log at Day 28 was observed in 57% (16/28) of the patients who received Albuferon at a dose > 450 mcg. A reduction in viral load of > 3.0 log at Day 28 was observed in a majority (5/8) of the 8 patients in the 900 mcg and 1200 mcg dose cohorts. 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. 3 The pharmacokinetic profile of Albuferon supports dosing every 2-4 weeks. Preliminary eight-week data are available from a separate ongoing Phase 2 clinical trial of Albuferon in patients with chronic hepatitis C who have failed to respond to previous interferon alpha-based treatment regimens. 4 The preliminary data show that Albuferon administered at 2-week or 4-week intervals in combination with ribavirin is safe, well tolerated, and demonstrates antiviral activity in all treatment groups for which data are available. David C. Stump, M.D., Executive Vice President, Drug Development, said, “The preliminary data from our ongoing Phase 2 clinical trial of Albuferon in interferon alpha-naïve patients are encouraging. These preliminary data will be presented in March at the annual meeting of the Canadian Association for Studies of the Liver, and an abstract has been accepted for presentation in April of the final results of the Phase 2 study in treatment-naïve patients at the annual meeting of the European Association for Studies of the Liver. The results of the current Phase 2 trial will enable us to identify 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. In addition, the preliminary data emerging from our ongoing Phase 2 combination study in treatment-experienced patients afford confidence in the ability to administer Albuferon safely in combination with ribavirin to treatment-naïve patients.” The results of a Phase 1/2 clinical trial of Albuferon in interferon alpha-experienced adults with chronic hepatitis C were presented at the November 2004 Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 5-6 Data presented on 119 patients demonstrate that Albuferon is well tolerated, has a prolonged half-life, is biologically active, and able to reduce viral load with dose-dependent magnitude and durability. On average, patients participating in the Phase 1/2 clinical trial had been treated previously for approximately 63 weeks with interferon alpha-containing regimens. Ninety-two percent of the patients (110/119) were infected with hepatitis C virus genotype 1, which accounts for nearly seventy percent of all HCV infections in North America. Patients were treated with one or two doses of Albuferon administered subcutaneously 14 days apart. Doses administered ranged from 7-900 mcg. The Phase 1/2 clinical trial results show that Albuferon is well tolerated, with adverse events that were mostly transient and mild to moderate in severity, and with no discontinuations due to adverse events or reductions in hematologic cell counts. Preliminary immunogenicity data presented at the AASLD meeting show that Albuferon immunogenicity occurs at rates consistent with those reported for other interferon alpha-based therapies, with no apparent correlation between the emergence of Albuferon antibodies and adverse events, antiviral response or pharmacokinetics. The vast majority of Albuferon antibody titers were low (<100 ng/mL). Viral load levels represent the quantity of hepatitis C virus in the blood and are a marker for drug activity. Forty-seven percent of Albuferon-treated patients in the combined single-dose and two-dose cohorts at doses of 120-900 mcg experienced an antiviral response, as demonstrated by reductions in viral load of 1.0 log or greater. The data presented show that both magnitude and duration of early anti-viral response were dose-dependent. 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. 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, 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. 7-14 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:
CONTACT: |