- Results demonstrated 17% overall rate of sustained virologic response in
non-responders to previous interferon-based therapy -
- SVR results in line with previous studies of long-acting interferons in
non- responders, with less frequent dosing -
- Final data from Phase 2 Albuferon non-responder study presented at the
Annual Meeting of the American Association for the Study of Liver Diseases
(AASLD) -
ROCKVILLE, Ma., Nov. 5 /PRNewswire-FirstCall/ -- Human Genome Sciences,
Inc. (Nasdaq: HGSI) today announced the final results of a Phase 2 trial of
the investigational drug, Albuferon(R) (albinterferon alfa-2b), in
combination with ribavirin in patients with chronic hepatitis C who failed
to respond to previous interferon-based therapy. The results were presented
yesterday in Boston at the 58th AASLD Annual Meeting in Boston.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
"The results of the Albuferon non-responder study demonstrated that
Albuferon treatment at doses up to 1800 mcg every two weeks had an
acceptable long-term safety profile and produced an overall sustained
virologic response (SVR) rate of 17% in these patients," said David Nelson,
M.D., Associate Professor of Medicine, Medical Director of Liver
Transplantation, and Chief of the Hepatobiliary Disease Section, University
of Florida. "In the difficult to treat subgroup of genotype 1 chronic
hepatitis C patients who previously failed to respond to treatment with
pegylated interferon and ribavirin, Albuferon treatment produced an overall
SVR rate of 11%."
In the open-label, multi-center, dose-escalation Phase 2 trial,
nonresponders to previous interferon-based therapy were randomized into
three Albuferon treatment groups (900 mcg every two weeks, 1200 mcg every
two weeks, and 1200 mcg every four weeks, followed by sequential escalation
to 1500 mcg every two weeks, and 1800 mcg every two weeks). A total of 115
patients participated. All patients received weight-based oral ribavirin
daily. The primary efficacy endpoint was sustained virologic response
(SVR), defined as undetectable virus in the blood at 24 weeks post-48 weeks
of treatment.
In two additional press releases issued by HGS today, the Company
announced the full presentations at AASLD of efficacy and safety data, and
quality-of-life data, from the Phase 2b trial of Albuferon in
treatment-naive patients. These data demonstrated that, with half the
injections required by the pegylated interferons, Albuferon provided at
least comparable efficacy, comparable safety and the potential for less
impairment of health-related quality of life and daily activity.
Key Findings from the Phase 2 Study in Non-Responders
Albuferon treatment in doses up to 1800 mcg every two weeks resulted in
significant antiviral activity in previous nonresponders to
interferon-based treatment for chronic hepatitis C. The overall SVR rate
was 17.4%. In the important subgroup of genotype 1 patients who were
previous nonresponders to treatment with a combination of pegylated
interferon and ribavirin, the SVR rate was 10.7%. SVR rates by Albuferon
treatment group were: 25% for 1200 mcg every four weeks; 30% for 900 mcg
every two weeks; 13% for 1200 mcg every two weeks; 9% for 1500 mcg every
two weeks; and 9% for 1800 mcg every two weeks. These SVR results are
consistent with those observed with other long- acting interferons in
patient populations that have failed prior interferon- based treatment
regimens.
Albuferon had an acceptable long-term safety profile at all doses,
including 1500 mcg and 1800 mcg. The most common adverse events were
fatigue, headache, arthralgia (joint pain), myalgia (muscle pain),
insomnia, nausea, cough, and pyrexia (fever). Discontinuation rates due to
adverse events were: 4.2% for the 1200 mcg every four weeks group; 17.4%
for the 900 mcg every two weeks group; 4.2% for the 1200 mcg every two
weeks group; 9.1% for the 1500 mcg every two weeks group; and 18.2% for the
1800 mcg every two weeks group. Hematologic reductions stabilized by Week
8, were well managed with dose reductions, and returned to baseline
following the completion of therapy.
"The results emerging from our Phase 2 program continue to support our
belief that Albuferon could become an important therapeutic option for
patients with chronic hepatitis C, including those that have failed prior
therapy," said Mani Subramanian, M.D., Ph.D., Senior Director of Clinical
Research, Infectious Diseases, HGS.
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: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, Kate de Santis, Director,
Investor Relations, +1-301-251-6003, both of Human Genome
Sciences, Inc.
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