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Human Genome Sciences Announces Presentation at AASLD of Results of Phase 2b Trial of Albuferon(R) for Chronic Hepatitis C
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- Albuferon requires half as many injections as standard therapy, and demonstrated at least comparable efficacy, comparable safety and less impairment of quality of life on treatment -- Final results of Phase 2b trial of Albuferon in treatment-naive hepatitis C patients presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) -
November 05, 2007: 07:00 AM EST
ROCKVILLE, Md., Nov. 5 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. today announced the final results of a Phase 2b clinical trial of the investigational drug, Albuferon(R) (albinterferon alfa-2b), in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. This Phase 2b study demonstrated that, with half as many injections as Pegasys (peginterferon alfa 2a), Albuferon was just as effective in achieving sustained virologic response (SVR) - an undetectable amount of virus in the blood at 24 weeks following the end of treatment - with comparable safety and less impairment of health-related quality of life on treatment. Albuferon is administered every two weeks, while peginterferon alfa-2a requires administration every week.
The final Phase 2b data are being presented this week at the 58th AASLD Annual Meeting in Boston. In two additional press releases also issued by HGS today, the Company announced the full presentations at AASLD of quality-of- life data from the Phase 2b trial, and results from the Phase 2 trial of Albuferon in combination with ribavirin in patients with chronic hepatitis C who had not responded to previous interferon-based treatment regimens.
"The final Phase 2b results suggest that the every-two-week dosing regimen of Albuferon halves the number of injections that are required with peginterferon alfa-2a, while providing at least comparable efficacy, comparable safety and the potential for less impairment of quality of life and daily activity," said Stefan Zeuzem, M.D., Professor of Medicine and Chief, Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany. "We are continuing the evaluation of the 900-mcg and 1200-mcg doses of Albuferon in larger populations in Phase 3 trials. We also conclude that monthly dosing of Albuferon deserves further evaluation."
In the open-label, multi-center, active-controlled Phase 2b trial, 458 treatment-naive patients with genotype 1 chronic hepatitis C were randomized to four treatment groups: Albuferon 900 mcg every two weeks, Albuferon 1200 mcg every two weeks, Albuferon 1200 mcg every four weeks, and peginterferon alfa-2a 180 mcg once a week. All patients received weight-based oral ribavirin daily. The trial included 48 weeks of treatment, and the primary efficacy endpoint was SVR, defined as undetectable viral load (HCV RNA<10 IU/mL) at 24 weeks following completion of treatment.
"Assuming that the Phase 2 results are confirmed in Phase 3, we believe that Albuferon could become the interferon of choice in combination regimens for the treatment of chronic hepatitis C," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "Both of our Phase 3 trials have completed enrollment ahead of schedule, and we expect to have Phase 3 data available by spring 2009 to support the filing of global marketing authorization applications by fall 2009."
Key Findings from the Phase 2b Study
Albuferon requires half the number of injections as peginterferon alfa-2a, and the final results of the Phase 2b study demonstrated that Albuferon provided at least comparable efficacy and comparable safety vs. peginterferon alfa-2a (ITT analysis), with less impairment of quality of life on treatment and fewer lost days of work.
The final Phase 2b results include the following SVR rates and other findings:
Albuferon 900-mcg Every Two Weeks (Albuferon 900 Q2w)
-- Based on an intention-to-treat (ITT) analysis, 58.5% of patients in the
Albuferon 900 Q2w treatment group achieved SVR, vs. 57.9% for
peginterferon alfa-2a administered every week.
-- In heavier patients (75 kg or heavier) who were treatment-adherent,
74.2% of those in the Albuferon 900 Q2w treatment group achieved SVR,
versus 53.3% for peginterferon alfa-2a.
-- Among all treatment-adherent patients in the Albuferon 900 Q2w
treatment group, 72.3% achieved SVR, versus 66.7% for peginterferon
alfa-2a.
-- Based on the SF-36 Health Survey, patients in the Albuferon 900 Q2w
treatment group reported less impairment of health-related quality of
life, compared with patients in the peginterferon alfa-2a treatment
group, as measured by both physical component and mental component SF-
36 summary measures at all time-points throughout the 48-week treatment
period.
-- Significantly fewer working patients in the Albuferon 900 Q2w treatment
group reported missing 7 days or more of work during the month prior to
their visits at Weeks 12 and 24, vs. the peginterferon alfa-2a group
(p<.05; Week 12: 4.2% for Albuferon 900 Q2w vs. 18.1% for
peginterferon alfa-2a; Week 24: 5.3% for Albuferon 900 Q2w, vs. 20.3%
for peginterferon alfa-2a).
-- The rate of discontinuations due to adverse events was 9.3% in the
Albuferon 900 Q2w treatment group, vs. 6.1% in the peginterferon alfa-
2a group. Adverse events observed were those typically expected with
interferon therapy.
Albuferon 1200-mcg Every Two Weeks (Albuferon 1200 Q2w)
-- ITT analysis shows that 55.5% of patients in the Albuferon 1200 Q2w
treatment group achieved SVR, vs. 57.9% for peginterferon alfa-2a
administered every week.
-- In heavier patients (75 kg or heavier) who were treatment-adherent,
67.9% of those in the Albuferon 1200 Q2w treatment group achieved SVR,
versus 53.3% for peginterferon alfa-2a every week.
-- Among all treatment-adherent patients in the Albuferon 1200 Q2w
treatment group, 70.6% achieved SVR, versus 66.7% for peginterferon
alfa-2a.
-- ITT analysis shows that the Albuferon 1200 Q2w treatment group
exhibited a robust early antiviral response (reduction in hepatitis C
RNA viral load to below the level of quantitation): 74.5% for
Albuferon 1200 Q2w at Week 12, vs. 65.8% for peginterferon alfa-2a.
The Albuferon 1200 Q2w treatment group also had the most rapid time to
HCV RNA negativity.
-- The rate of discontinuations due to adverse events was 18.2% in the
Albuferon 1200 Q2w treatment group, vs. 6.1% in the peginterferon alfa-
2a group. Adverse events observed were those typically expected with
interferon therapy. Dose reductions were attempted in only 24.4% of
Albuferon subjects prior to discontinuation, versus 42.9% for
peginterferon alfa-2a. Adverse events observed were those typically
expected with interferon therapy.
"In the Albuferon Phase 3 trials, we are strongly encouraging titration of dose where necessary to increase tolerability, reduce the rate of discontinuations, and maximize the therapeutic benefit of the robust early antiviral response offered by the 1200-microgram dose on a two-week administration schedule," said Dr. Stump.
Albuferon 1200-mcg Monthly (Albuferon 1200 Q4w)
-- ITT analysis shows that 50.9% of patients in the Albuferon 1200 Q4w
treatment group achieved SVR, vs. 57.9% for peginterferon alfa-2a
administered every week.
-- In heavier patients (75 kg or heavier) who were treatment-adherent,
61.0% of those in the Albuferon 1200 Q4w treatment group achieved SVR,
versus 53.3% for peginterferon alfa-2a administered once every week.
-- Among all treatment-adherent patients in the Albuferon 1200 Q4w
treatment group, 62.0% achieved SVR, versus 66.7% for peginterferon
alfa-2a.
-- The rate of discontinuations due to adverse events was 12.1% in the
Albuferon 1200 Q4w treatment group, vs. 6.1% in the peginterferon alfa-
2a group. Adverse events observed were those typically expected with
interferon therapy.
-- The number of patients experiencing severe hematologic adverse events
was significantly lower in the Albuferon 1200 Q4w treatment group
(10.3%, vs. 20.2% for peginterferon alfa-2a, p<0.05).
Higher doses of Albuferon administered every four weeks, in combination with ribavirin, will be explored in a separate Phase 2b trial conducted by Novartis, which is expected to begin by year-end 2007.
About Albuferon
Albuferon is a novel long-acting form of interferon alpha created by HGS using its proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for more than 20 days. Research shows that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a number of cancers.
Albuferon is being developed by HGS and Novartis for the treatment of chronic hepatitis C under a worldwide co-development and commercialization agreement entered into in June 2006. HGS and Novartis will co-commercialize Albuferon in the United States and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $132.5 million received to date.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus (HCV). An estimated 170 million people worldwide are infected with the virus, including nearly 4 million people in the United States. When detectable levels of HCV persist in the blood for at least six months, a person is diagnosed with chronic hepatitis C. Hepatitis C virus can cause serious liver disease, leading to cirrhosis, primary liver cancer and even death.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, anthrax disease, cancer and other immune-mediated diseases. The Company's primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon for hepatitis C and LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both drugs are ongoing.
ABthrax(TM) (raxibacumab) is in late-stage development for the treatment of anthrax disease, and the Company is on track to begin the delivery in 2008 of 20,000 doses of ABthrax to the Strategic National Stockpile under a contract entered into with the U.S. Government in June 2006. Other HGS drugs in clinical development include two TRAIL receptor antibodies for the treatment of cancers.
For more information about HGS, please visit the Company's web site at www.hgsi.com. To view the AASLD oral presentation reporting results of the Phase 2b clinical trial of Albuferon in combination with ribavirin in treatment-naive patients (Zeuzem, et al), click here. To view the AASLD poster presentation reporting quality of life results from the Phase 2b clinical trial of Albuferon (Pianko, et al), click here. To view the AASLD oral presentation reporting results of the Phase 2 trial of Albuferon in non- responders (Nelson, et al), click here. To view the AASLD poster presentation reporting results of a prospective comparison of commercial fibrosis serum marker panels (Patel, et al), click here. For more information about Albuferon, please visit www.hgsi.com/products/albuferon.html. Health professionals or patients interested in Albuferon clinical trials or other studies involving HGS products may 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, 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 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.
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