- Human Genome Sciences' ABthrax(TM) shows lifesaving potential -
- HGS on track to deliver 20,000 doses to Strategic National Stockpile
beginning in 2008 -
ROCKVILLE, Md., Dec. 18 /PRNewswire-FirstCall/ -- Human Genome
Sciences, Inc. (Nasdaq: HGSI) today announced that the results of two
animal studies demonstrated the life-saving potential of its human
monoclonal antibody drug ABthrax(TM) (raxibacumab). The results show that a
single dose of ABthrax, administered without concomitant antibiotics,
improved survival rates by up to 64 percent when administered after animals
were symptomatic for anthrax disease as a result of inhalation exposure to
massively lethal doses of anthrax spores. These dramatic and statistically
significant findings demonstrate a survival benefit in two animal species,
which is the requirement for establishing the efficacy of new drugs used to
counter bioterrorism.
(Logo: http://www.newscom.com/cgi-bin/prnh/20010612/HGSLOGO )
"We believe that ABthrax offers a significant step forward in the
treatment of inhalational anthrax, and could play an important role in
strengthening America's arsenal against bioterrorism," said H. Thomas
Watkins, President and Chief Executive Officer, HGS.
ABthrax, which specifically targets anthrax toxins and is being
developed under contract with the Biomedical Advanced Research and
Development Authority (BARDA), represents a new way to address the anthrax
threat. While antibiotics can kill the Bacillis anthracis bacteria, they
are not effective against the deadly toxins that the bacteria produce --
the real culprits in anthrax- related deaths. ABthrax targets anthrax
toxins after they are released into the blood. In an inhalation anthrax
attack, people may not know they are infected with anthrax until the toxins
already are circulating in their blood, and it may be too late for
antibiotics alone to be effective.
"These results show that ABthrax was highly effective as a treatment
for anthrax in both rabbits and monkeys, and acted quickly to provide a
significant survival benefit to animals showing clinical symptoms caused by
exposure to massively lethal aerosolized doses of anthrax spores," said
David C. Stump, M.D., Executive Vice President, Research and Development,
HGS. "The new data are consistent with the results of previous studies in
multiple animal models, which demonstrated that a single dose of ABthrax
given prophylactically provided up to 100% protection against death."
HGS said that it has met all milestones to date under the Company's
contract with the U.S. Department of Health and Human Services (HHS), and
is on track to deliver ABthrax to the Strategic National Stockpile
beginning in 2008.
"We have demonstrated the efficacy of ABthrax in multiple therapeutic
and prophylactic animal models of inhalational anthrax," said James H.
Davis, Ph.D., J.D., Executive Vice President and General Counsel, HGS. "We
have demonstrated that it was generally safe and well tolerated in two
clinical trials to date in healthy adults. We have manufactured conformance
lots of ABthrax and are currently producing ABthrax for delivery to the
Stockpile. We have more work to do, but our interactions with HHS, FDA and
CDC continue to be positive, and the ABthrax program is progressing well."
Research Findings
In one of the animal studies, three groups of monkeys were exposed by
inhalation to anthrax spores and treated with either ABthrax or placebo
after they showed clinical signs of anthrax disease. After 28 days, the
study found that:
-- 64.3 percent of monkeys that received a single high dose of ABthrax
survived (p=0.0007 vs. placebo).
-- 50 percent of those that received a low dose survived (p=0.0064 vs.
placebo).
-- None of the monkeys in the placebo control group survived.
A separate study that measured 14-day survival in rabbits also
demonstrated a statistically significant survival benefit versus placebo.
All ABthrax-treated animals that survived in both studies were rapidly
cleared of anthrax toxin and bacteria following intravenous administration
of a single dose of ABthrax. In contrast, all placebo-treated animals
remained bacteremic or toxemic and died.
HGS also reported today that it has completed the second safety study
of ABthrax in human volunteers, bringing the total number of people who
have participated in human safety trials to more than 180. The clinical
results to date suggest that ABthrax was generally safe and well tolerated.
In addition, the new study demonstrated that co-administration of ABthrax
with the antibiotic Cipro (ciprofloxacin) did not affect the
pharmacokinetics of either Cipro or ABthrax, and suggested that ABthrax can
be administered in combination with antibiotics. This is a key finding
given the important role that antibiotics are expected to continue to play
in the treatment of anthrax disease.
The Need for New Means to Fight Anthrax Infections
Two options are currently available for the prevention or treatment of
anthrax infections -- a vaccine and antibiotics. Both are essential to
dealing with anthrax, but both have limitations. The anthrax vaccine takes
several weeks following the initial doses before immunity is detectable,
and requires multiple injections over a period of eighteen months, in
addition to annual booster vaccination, to maintain protective immunity.
Antibiotics are effective in killing anthrax bacteria, but are not
effective against the anthrax toxins once those toxins have been released
into the blood. Antibiotics also may not be effective against
antibiotic-resistant strains of anthrax.
ABthrax is a human monoclonal antibody to Bacillus anthracis protective
antigen that was discovered and developed by HGS, using technology that HGS
has integrated into the Company as part of its collaboration with Cambridge
Antibody Technology. ABthrax was the first investigational agent against
anthrax infection to be evaluated in a clinical study following the 2001
anthrax attacks in the United States. In 2003, ABthrax received a Fast
Track Product designation from the FDA, as well as an Orphan Drug
Designation for its use in the treatment of inhalational anthrax disease.
In contrast to the anthrax vaccine, the protection afforded by a single
dose of ABthrax would be immediate following the rapid achievement of
appropriate blood levels of ABthrax. In contrast to antibiotics, ABthrax
acts against the deadly toxins produced by anthrax bacteria. It may also
prevent and treat infections by antibiotic-resistant strains of anthrax.
The ABthrax Contract with the U.S. Government
In June 2006, the U.S. Government exercised its option to purchase
ABthrax for the Strategic National Stockpile (Contract Number
HHS010020050006C). HGS expects to receive $165 million in revenues from
this award, with the majority to come in 2008, when the Company begins to
deliver ABthrax. The purchase award was made by the U.S. Department of
Health and Human Services (HHS) under the Project BioShield Act of 2004,
which is designed to accelerate the development, purchase and availability
of medical countermeasures for the Strategic National Stockpile.
Under the contract, HGS will manufacture and deliver 20,000 treatment
courses of ABthrax to the Strategic National Stockpile. The Company is also
working closely with HHS, FDA and CDC to complete the additional laboratory
and clinical testing required to support the filing of a Biologics License
Application (BLA), and to support the use of ABthrax in patients with
inhalational anthrax disease in the event of an emergency prior to FDA
licensure.
About Anthrax
Anthrax infection is caused by a spore-forming bacterium, Bacillus
anthracis, which multiplies in the body and produces lethal toxins. Most
anthrax fatalities are caused by the irreversible effects of the anthrax
toxins. Research has shown that the bacteria produce protective antigen,
the key facilitator in the progression of anthrax infection at the cellular
level. After protective antigen and the anthrax toxins are produced by the
bacteria, protective antigen binds to the anthrax toxin receptor on cell
surfaces and forms a protein-receptor complex that makes it possible for
the anthrax toxins to enter the cells. ABthrax blocks the binding of
protective antigen to cell surfaces and prevents the anthrax toxins from
entering and killing the cells.
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(R) (albinterferon
alfa- 2b) for hepatitis C and LymphoStat-B(R) (belimumab) for lupus. Phase
3 clinical trials of both drugs are ongoing. ABthrax (raxibacumab) is in
late- stage development for the treatment of anthrax disease. 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. For more information about ABthrax, please visit
http://www.hgsi.com/products/ABthrax.html. Health professionals or patients
interested in 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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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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