BioCryst
Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that investigators at
St. Jude Children's Research Hospital, Memphis, TN, reported favorable
results evaluating peramivir treatment in an animal model of influenza
using a highly virulent strain of H5N1 virus (an avian influenza strain
that had caused fatal human infection in Viet Nam). The study, presented on
April 30, 2007 by Dr. David Boltz at the 20th International Conference on
Antiviral Research, Palm Springs, CA, concluded that peramivir is an
effective treatment when administered intramuscularly to control H5N1
infection in mice and that these data support the potential use of this
drug to control influenza in the event of a pandemic.
The objective of the study was to achieve complete protection against
lethal H5N1 influenza virus infection in the mouse model through the use of
intramuscular administration of peramivir, a potent neuraminidase inhibitor
with antiviral activity against strains of influenza viruses, including
seasonal strains and influenza H5N1 strains from avian origins.
A survival rate of 40% to 60% was observed in mice treated with one or
two injections of peramivir; however, 100% survival of mice was achieved by
two injections of peramivir on the first day followed by once-daily
administration for 7 days. The longer duration of peramivir treatment also
prevented viral replication in the tissues of the lungs, brain and spleen
of the mice at the 3, 6, and 9 day post-inoculation time points.
W. James Alexander, MD, MPH, BioCryst Senior Vice President for
Clinical Operations commented, "The results of this St. Jude study,
performed under the careful guidance of Drs. Elena Govorkova and Robert
Webster, bolsters our confidence that peramivir may be clearly beneficial
in the treatment of severe influenza, including human influenza due to
strains of avian origin. We wish to congratulate our colleagues at St. Jude
on the successful conduct of an elegant study which not only confirms but
significantly extends the observations of the previous animal study
reported last year by NIH showing positive effects of peramivir in a
similar model of H5N1 influenza virus infection."
BioCryst is advancing the clinical development of peramivir under terms
of a contract from the U.S. Department of Health and Human Services (DHHS)
which on January 4, 2007 awarded BioCryst a $102.6 million, four-year
contract to develop peramivir for the treatment of seasonal and
life-threatening influenza. Funding from the contract will support
manufacturing of clinical lots, process validation, clinical studies and
other product approval requirements needed for U.S. licensure. BioCryst
retains 100% development and commercialization rights to peramivir
worldwide other than in Japan and Korea where BioCryst recently established
strategic partnerships with Shionogi & CO. in Japan, and Green Cross in
Korea.
About Peramivir
Peramivir is a member of the class of antiviral agents that inhibit
influenza viral neuraminidase, an enzyme that is essential for the spread
of influenza virus within the host. Peramivir is an inhibitor of influenza
A and B neuraminidases and certain strains of influenza viruses that may be
resistant to available neuraminidase inhibitors are susceptible to
peramivir in laboratory tests. At the 46th Annual Interscience Conference
on Antimicrobial Agents and Chemotherapy in September, 2006, data were
presented showing that injectable formulations of peramivir were safely
administered to healthy subjects at daily doses up to approximately 600 mg.
At the same meeting, animal data were presented showing peramivir promoted
survival in animals infected with highly pathogenic strains of the H5N1
virus. Peramivir injection has received Fast Track designation from US FDA
and the availability of an intravenous neuraminidase inhibitor may be
important in treating patients hospitalized with severe and potentially
life-threatening influenza. The availability of an intramuscular
formulation of peramivir could ensure appropriate dosing which may be a
concern with currently available oral or inhaled anti-influenza agents.
About Influenza
The influenza virus causes an acute viral disease of the respiratory
tract. Unlike the common cold and some other respiratory infections,
seasonal flu can cause severe illness, resulting in life-threatening
complications. According to the Centers for Disease Control and Prevention,
every year in the United States more than 200,000 people are hospitalized
from flu complications, and about 36,000 people die from flu. Most at risk
are young children, the elderly, and people with seriously compromised
immune systems.
Avian influenza A viruses of H5N1 subtype are circulating among birds
worldwide, the virus is considered extremely contagious in fowl. It is
believed that all species of birds are susceptible to avian influenza, but
domestic poultry, including chickens and turkeys, are among the more
susceptible to the highly pathogenic strain. According to the World Health
Organization, at least 261 people have contracted H5N1 avian influenza, of
which at least 157 have died. Almost all of these infections are believed
to have resulted from contact with infected poultry.
About BioCryst
BioCryst Pharmaceuticals, Inc. is a leader in the use of
crystallography and structure-based drug design for the development of
novel therapeutics to treat cancer, cardiovascular diseases, autoimmune
diseases, and viral infections. The company is advancing multiple internal
programs toward potential commercialization including Fodosine(TM) in
oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir
in seasonal and life- threatening influenza. BioCryst has a worldwide
partnership with Roche for the development and commercialization of
BCX-4208, and is collaborating with Mundipharma for the development and
commercialization of Fodosine(TM) in markets across Europe, Asia, Australia
and certain neighboring countries. In January, 2007 the U.S. Department of
Health and Human Services (DHHS) awarded a $102.6 million, four-year
contract to BioCryst for advanced development of peramivir to treat
seasonal and life-threatening influenza. In February, 2007 BioCryst
established a partnership with Shionogi & Co., to develop and commercialize
peramivir in Japan. For more information about BioCryst, please visit the
company's web site at biocryst.
Forward-looking statements
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. These
statements involve known and unknown risks, uncertainties and other factors
which may cause our actual results, performance or achievements to be
materially different from any future results, performances or achievements
expressed or implied by the forward-looking statements. These statements
reflect our current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these
uncertainties, you should not place undue reliance on these forward-looking
statements. Some of the factors that could affect the forward-looking
statements contained herein include that the favorable results of peramivir
in animals may not be replicated in humans, that development and
commercialization of Fodosine(TM) in both T-ALL and CTCL may not be
successful, that we may not resolve satisfactorily the particulate matter
issue with the intravenous formulation of Fodosine(TM), that we may not
obtain a satisfactory SPA for Fodosine(TM) for treatment of CTCL promptly
or at all, that DHHS could reduce or eliminate funding for peramivir, that
we or our licensees may not be able to enroll the required number of
subjects in planned clinical trials of our product candidates and that such
clinical trials may not be successfully completed, that BioCryst or its
licensees may not commence as expected additional human clinical trials
with our product candidates, that our product candidates may not receive
required regulatory clearances from the FDA, that ongoing and future
clinical trials may not have positive results, that we may not be able to
complete successfully the Phase IIb trial for Fodosine(TM) that is
currently planned to be pivotal, that we or our licensees may not be able
to continue future development of our current and future development
programs, that our development programs may never result in future product,
license or royalty payments being received by BioCryst, that BioCryst may
not reach favorable agreements with potential pharmaceutical and biotech
partners for further development of its product candidates, that BioCryst
may not have sufficient cash to continue funding the development,
manufacturing, marketing or distribution of its products and that
additional funding, if necessary, may not be available at all or on terms
acceptable to BioCryst. Please refer to the documents BioCryst files
periodically with the Securities and Exchange Commission, specifically
BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, current reports on Form 8-K which identify important factors
that could cause the actual results to differ materially from those
contained in the projections or forward-looking statements.
BioCryst Pharmaceuticals, Inc.
biocryst
Комментариев нет:
Отправить комментарий