Avant’s Typhoid Fever Vaccine Demonstrates Excellent Clinical Potential
Single-Dose Oral Ty800 Vaccine Immunogenic & Well-Tolerated in NIH-Sponsored Phase 1/2 Study
NEEDHAM, MA (May 18, 2007) - AVANT Immunotherapeutics, Inc.
(Nasdaq: AVAN) announced today positive preliminary results from an
investigational double-blind, placebo-controlled Phase 1/2
dose-escalating clinical trial of its typhoid fever vaccine
candidate, Ty800, in healthy volunteers. The researchers found the
single-dose, oral vaccine to be well tolerated and immunogenic,
with over 90% of vaccinated subjects generating immune responses.
Based on these excellent results, AVANT plans to further develop
Ty800 to compete in the expanding typhoid fever vaccine market,
which currently has over $200 million in annual sales. AVANT plans
to initiate its own sponsored Phase 2 dose-ranging trial of Ty800
in mid-2007.
“Typhoid fever remains endemic in many developing areas of
the world, as well as being an important potential health threat
for travelers and military personnel in areas affected by the
disease,” said Dr. Mitchell B. Cohen, Principal Investigator
in the study and Director of Gastroenterology, Hepatology and
Nutrition at Cincinnati Children’s Hospital Medical Center.
“The development of an effective and practical vaccine for
all ages will provide an important tool for controlling this
disease. A safe typhoid fever vaccine that can be easily
administered could significantly reduce the morbidity and mortality
associated with typhoid fever.”
“We are delighted with these results for our single-dose,
oral Ty800 vaccine candidate,” said Una S. Ryan, Ph.D.,
President and Chief Executive Officer of AVANT Immunotherapeutics,
Inc. “These results indicate that AVANT’s vaccine may
have significant potential advantages over the currently licensed
vaccines, which offer limited protection rates of 50-80% and
require either a single needle injection or three to four oral
doses over the course of a week. We believe a more efficacious,
easier-to-use typhoid fever vaccine could greatly expand the
current markets for both travelers in developed countries and mass
immunization programs in developing countries.”
The Phase 1/2 study was an in-patient dose-escalating clinical
trial aimed at determining the safety and immunogenicity of the
single-dose, oral Ty800 vaccine. The trial evaluated three
escalating dose levels of the vaccine in 47 healthy adult
volunteers and followed each volunteer for six months
post-vaccination. The clinical trial was sponsored by the National
Institute of Allergy and Infectious Diseases (NIAID) of the
National Institutes of Health (NIH), and was conducted at the
Cincinnati Children’s Hospital Medical Center. This clinical
trial has been funded in whole or in part with Federal funds from
the NIAID of the NIH, Department of Health and Human Services,
under contract No. NO AI 25459.
About the Ty800 Vaccine
AVANT has designed the Ty800 vaccine to offer rapid, oral,
single-dose protection against Salmonella typhi, the cause of
typhoid fever. The Ty800 vaccine was developed using genetic
techniques to delete specific genes known to be essential to the
virulence of S. typhi. The clinical trial was designed to show
whether Ty800 would be well tolerated in humans and rapidly elicit
strong immune responses.
The Study
A total of 47 healthy volunteers participated in the Ty800 study.
Thirty-three subjects were randomly sorted into three different
dose groups having mean doses administered of 8x107, 6x108 and
1x1010 colony-forming units (CFUs) and 14 received a placebo
consisting of buffer only. The dose of 6x108 CFU in this study
appeared to be immunogenic with similar reactogenicity as placebo.
In addition, over 90% of vaccinees showed positive immune responses
for both systemic (IgG) and mucosal (IgA) antibodies to typhoid
based on an ELISPOT assay. Results of the study are being presented
today at a vaccines meeting in Baltimore, MD entitled
“Progress and Opportunities in the Prevention of Enteric
Disease” by the Principal Investigator, Dr. Cohen. It is
expected that detailed results of the study will be published in a
scientific journal.
About AVANT Immunotherapeutics, Inc.
AVANT Immunotherapeutics, Inc. discovers and develops innovative
vaccines and therapeutics that harness the human immune system to
prevent and treat disease. AVANT has three products on the market
and four of AVANT’s products are in clinical development.
AVANT’s pipeline includes products for travelers’
vaccines and global health needs based on AVANT’s oral,
rapid-protecting, single-dose and temperature-stable vaccine
technology.
Additional information on AVANT Immunotherapeutics, Inc. can be
obtained through its site on the World Wide Web: http://www.avantimmune.com.
Safe Harbor Statement Under the Private Securities Litigation
Reform Act of 1995: This release includes forward-looking
statements that are subject to a variety of risks and uncertainties
and reflect AVANT’s current views with respect to future
events and financial performance. There are a number of
important factors that could cause the actual results to differ
materially from those expressed in any forward-looking statement
made by AVANT. These factors include, but are not limited to:
(1) the integration of multiple technologies and programs; (2) the
ability to adapt AVANT’s vectoring systems to develop new,
safe and effective orally administered vaccines against anthrax and
plague or other any other microbes used as bioweapons and other
disease causing agents; (3) the ability to successfully complete
product research and further development, including animal,
pre-clinical and clinical studies, and commercialization of
CholeraGarde® (Peru-15), Ty800, ETEC E. coli vaccine, VLPs and
other products and AVANT’s expectations regarding market
growth; (4) the cost, timing, scope and results of ongoing safety
and efficacy trials of CholeraGarde® (Peru-15), Ty800, ETEC E.
coli vaccine and other preclinical and clinical testing; (5) the
ability to negotiate strategic partnerships or other disposition
transactions for AVANT’s cardiovascular programs, including
TP10 and CETi; (6) the ability of AVANT to manage multiple clinical
trials for a variety of product candidates; (7) AVANT’s
expectations regarding its technological capabilities and expanding
its focus to broader markets for vaccines; (8) the Company’s
expectations regarding the cost of funding its development
partnership with Select Vaccines Limited for the influenza vaccine,
the opportunity to extend to other disease targets, and
AVANT’s ability to develop products through this
collaboration; (9) changes in existing and potential relationships
with corporate collaborators; (10) the availability, cost, delivery
and quality of clinical and commercial grade materials produced at
AVANT’s own Manufacturing facility or supplied by contract
manufacturers and partners; (11) the timing, cost and uncertainty
of obtaining regulatory approvals; (12) the ability to develop and
commercialize products before competitors that are superior to the
alternatives developed by competitors; (13) the ability to retain
certain members of management;(14) AVANT’s expectations
regarding research and development expenses and general and
administrative expenses; (15) AVANT’s expectations regarding
cash balances, capital requirements, anticipated royalty payments
(including those from Paul Royalty Fund), revenues and expenses,
including infrastructure expenses; (16) our belief regarding the
validity of our patents and potential litigation; and (17) certain
other factors that might cause AVANT’s actual results to
differ materially from those in the forward-looking statements
including those set forth under the headings
“Business,” “Risk Factors” and
Management’s Discussion and Analysis of Financial Condition
and Results of Operations” in each of AVANT’s Annual
Report on Form 10-K, its Quarterly Reports on Form 8-K, as well as
those described in AVANT’s other press releases and filings
with the Securities and Exchange Commission, from time to
time. You should carefully review all of these factors, and
you should be aware that there may be other factors that could
cause these differences. These forward-looking statements
were based on information, plans and estimates at the date of this
press release, and AVANT does not promise to update any
forward-looking statements to reflect changes in underlying
assumptions or factors, new information, future events or other
changes.
Posted: May 2007
