- Albuferon was associated with fewer missed work days and less impairment
of quality of life on treatment than peginterferon alfa-2a -
- Final Albuferon Phase 2b quality-of-life data 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 quality-of-life results from
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. The study demonstrated that
patients in the Albuferon treatment groups reported fewer missed days of
work and less impairment of health-related quality of life on treatment
compared to the Pegasys (peginterferon alfa-2a) group.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
The final Phase 2b quality-of-life results are being presented this
week at the 58th AASLD Annual Meeting in Boston. In two additional press
releases issued by HGS today, the Company announced the full presentations
at AASLD of efficacy and safety data from the Phase 2b trial of Albuferon
in treatment- naive patients, and results from the Phase 2 trial of
Albuferon in combination with ribavirin in patients who did not respond to
prior therapy.
"Patients undergoing treatment for chronic hepatitis C often find it
challenging to go to work or participate in other normal daily activities,
especially in the days following dose administration," said Stephen Pianko,
M.D., F.R.A.C.P., Ph.D., Monash University, Melbourne, Australia. "The
results of the Phase 2b trial suggest that Albuferon may have the potential
to offer a therapeutic alternative with fewer lost days of work and less
impairment of health-related quality of life on treatment, compared with
peginterferon alfa-2a, with at least comparable efficacy and safety. We
look forward to further evaluation of Albuferon's impact on patient quality
of life in the ongoing Phase 3 trials."
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. Health-related quality of life was assessed using the Short
Form 36 (SF-36) health survey. SF-36 is a validated 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.
"Strongly positive overall quality-of-life results were observed for
the Albuferon treatment groups, and they were strongest among patients
receiving the Albuferon 900-mcg dose every two weeks," said David C. Stump,
M.D., Executive Vice President, Research and Development, HGS. "This
Albuferon treatment group achieved a statistically significant reduction in
the number of missed work days compared with peginterferon alfa-2a, and
also achieved statistically and clinically meaningful differences in many
of the SF-36 quality-of-life domains."
Key Quality-of-Life Findings from the Phase 2b Study
Working patients in all Albuferon treatment groups recorded fewer days
of missed work than was observed in the peginterferon alfa-2a treatment
group. All Albuferon groups showed less impairment of health-related
quality of life based on SF-36 physical and mental component summary
scores.
Significantly fewer working patients taking Albuferon 900 mcg every two
weeks reported missing 7 days or more of work during the month prior to
their treatment visits at Weeks 12 and 24, vs. patients taking
peginterferon alfa- 2a. At week 12, only 4.2% of patients taking Albuferon
900 mcg every two weeks had missed 7 or more days of work the previous
month, compared with 18.1% of peginterferon alfa-2a patients (p<.05). At
week 24, only 5.3% of Albuferon 900-mcg patients had missed 7 or more days
of work the previous month, compared with 20.3% of peginterferon alfa-2a
patients (p<.05). At Week 12, working patients taking Albuferon 900-mcg
every two weeks reported missing an average of 1.1 days of work during the
previous month, while peginterferon alfa-2a patients reported missing an
average of 4.3 work days (p<.05). At Week 24, Albuferon 900-mcg patients
had missed an average of 1.6 days of work during the previous month, while
peginterferon alfa-2a patients had missed an average of 4.7 work days.
At Weeks 12 and 24, the treatment group taking Albuferon 900 mcg every
two weeks also reported better scores for all eight SF-36 physical and
mental health domains, as well as the physical and mental summary scores,
compared with peginterferon alfa-2a. Statistically significant and
clinically meaningful differences were observed in the mental health,
bodily pain, vitality and social functioning domains. By the Week 12
follow-up visit after the end of treatment, changes in mental health as
measured by the Hospital Anxiety and Depression Scale (HADS) had recovered
to baseline in 67% of the patients taking Albuferon 900 mcg, compared with
57% of the peginterferon alfa-2a patients.
The treatment group taking Albuferon 1200 mcg every two weeks also
recorded fewer lost days of work and less impairment of health-related
quality of life on treatment than was reported for the peginterferon
alfa-2a group.
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
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
http://www.prnewswire.com/comp/121115.html/
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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