Healthcare Industry News: Albuferon
News Release - October 16, 2006
Human Genome Sciences Reports Positive Interim Quality-of-Life Data From Phase 2B Trial of Albuferon(TM) with Ribavirin in Treatment-Naive Hepatitis C PatientsAlbuferon associated with fewer missed work days and better patient-reported quality-of-life scores than pegylated interferon through Week 12
ROCKVILLE, Md., Oct. 16 (HSMN NewsFeed) -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) today reported 12-week interim quality-of-life results from a Phase 2b clinical trial to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon(TM) in combination with ribavirin in patients with genotype 1 chronic hepatitis C (HCV) who are naive to interferon alpha-based treatment regimens. The interim results demonstrate that all Albuferon treatment groups consistently performed favorably through Week 12 compared to the pegylated interferon alpha treatment group, based on patient-reported disability days and health-related quality of life as measured by the SF-36 health survey. The data were presented over this past weekend at the annual Australian Gastroenterology Week in Adelaide.
"Health-related quality-of-life issues, including lost days of work and normal activity, pose a significant challenge for patients undergoing treatment for chronic hepatitis C," said Stephen Pianko, M.D., F.R.A.C.P., Ph.D., Associate Professor of Medicine, Monash University (Melbourne, Australia). "Interim results of the current study suggest that Albuferon may have the potential to offer a therapeutic alternative with less impairment of health-related quality of life, and fewer disability days, compared with the current standard of care, with at least comparable safety and efficacy. We look forward to continuing the evaluation of Albuferon to determine its appropriate role in the treatment of hepatitis C."
"Through Week 12 of the Phase 2b study, patients in the Albuferon treatment groups recorded fewer missed work days and, based on the SF-36 health assessment, reported better quality of life than patients in the pegylated interferon treatment group," said David C. Stump, M.D., Executive Vice President, Drug Development, HGS. "This result was observed in both the physical and mental component summary measures, as well as in the 8 individual domain scores. The SF-36 results in mental health suggest significantly less impairment of psychological well-being across the Albuferon treatment groups."
About the Albuferon Phase 2B 12-Week Quality-of-Life Results
Albuferon treatment groups recorded fewer disability days and reported less impairment of health-related quality of life through Week 12 of the Phase 2b study than patients in the pegylated interferon treatment group. The 900- mcg Albuferon dose administered at two-week intervals was associated with 75% fewer disability days, and the 1200-mcg Albuferon doses administered at two- week and four-week intervals were associated with 25% fewer disability days. Through Week 12, based on the SF-36 health assessment, patient-reported outcomes showed that the Albuferon treatment groups consistently performed favorably compared to PEGASYS in both the physical and mental component summary measures and in the 8 individual domain scores. SF-36 results in the mental health domain demonstrated significantly less impairment of psychological well-being across the Albuferon treatment groups (p=0.002 vs. PEGASYS). Of the four treatment arms in the Phase 2b study, the 900-mcg Albuferon dose administered once every two weeks was significantly associated with the least negative impact on mental and physical function, bodily pain, vitality, social functioning, and mental health domains, while maintaining efficacy and safety at least comparable to pegylated interferon alpha. Less worsening of health-related quality of life also was observed in the treatment arms receiving 1200-mcg Albuferon doses administered at two-week and four-week intervals, respectively, compared to the pegylated interferon alpha treatment group, with clinically meaningful differences observed in bodily pain, mental health and social functioning.
Health-related quality of life was assessed using the Short Form 36 (SF-36) health survey. SF-36 is a patient-reported outcomes instrument, consisting of 36 questions used to measure the health status of patients with chronic hepatitis C. The 36 questions result in an 8-scale health profile including: physical function, physical role limitations, vitality, general health perceptions, pain, social function, emotional role limitations, and mental health. Summaries of the combined physical and mental component measures were also used in the assessment.
About the Albuferon Phase 2B Trial Design
Data are available through Week 12 on 458 patients enrolled in the randomized, open-label, multi-center, active-controlled, dose-ranging study, which is being conducted in Australia, Canada, Czech Republic, France, Germany, Israel, Poland and Romania. Patients were enrolled and randomized into four treatment groups, three of which receive subcutaneously administered Albuferon (900 mcg at two-week intervals, 1200 mcg at two-week intervals, and 1200 mcg at four-week intervals). The fourth treatment group serves as the active control group and receives 180-mcg doses of subcutaneously administered peginterferon alfa-2a (PEGASYS) once every week. All patients receive oral daily ribavirin. The primary efficacy endpoint of the Phase 2b study is sustained virologic response (SVR), defined as undetectable virus 24 weeks after completion of 48 weeks of treatment. The secondary endpoints include early virologic response at Week 12 (EVR12), and safety and health-related quality of life at Weeks 12, 24 and 48.
Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the Company's proprietary albumin fusion technology. This technology enables scientists to improve the pharmacological properties of therapeutic proteins by fusing the gene that expresses human albumin to the gene that expresses the active protein. Albuferon results from the genetic fusion of human albumin and interferon alpha 2b. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006.
About 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. 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. 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.
About Human Genome Sciences
The mission of Human Genome Sciences is to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.
The HGS clinical development pipeline includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company's primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon(TM) for hepatitis C, and LymphoStat-B(TM) for lupus. Both compounds are expected to advance to Phase 3 clinical trials in 2006.
In June 2006, HGS announced that the U.S. Government exercised its option under an existing contract to purchase 20,000 doses of ABthrax(TM) for the treatment of anthrax disease. Other HGS compounds in clinical development include three TRAIL receptor antibodies for the treatment of hematopoietic and solid malignancies, in addition to an antibody to the CCR5 receptor for the treatment of HIV/AIDS.
For more information about HGS, please visit the Company's web site at www.hgsi.com. For more information about Albuferon, visit http://www.hgsi.com/products/Albuferon.html. Health professionals or patients interested in inquiring about Albuferon clinical trials or any other study involving HGS products in development are encouraged to inquire via the Contact Us section of the company's web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
Safe Harbor Statement
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. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. 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.
Source: Human Genome Sciences
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