- 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) -
ROCKVILLE, Md., Nov. 5 /PRNewswire-FirstCall/ -- Human Genome Sciences,
Inc. (Nasdaq: HGSI) 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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
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
http://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
http://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, http://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.
SOURCE Human Genome Sciences, Inc.
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Related links:
http://www.hgsi.com
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CONTACT:
Jerry Parrott, Vice President, Corporate
Communications, +1-301-315-2777 or Kate de Santis, Director,
Investor Relations, +1-301-251-6003 both of Human Genome
Sciences, Inc.
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