NIH Initiates Phase 1 Safety Study of AVANT's Oral Combined Enterotoxigenic E. coli-Cholera Vaccine
04 Giugno 2008 - 1:00PM
Business Wire
AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) today announced that
the Division of Microbiology and Infectious Diseases of the
National Institute of Allergy and Infectious Diseases (NIAID), an
institute of the National Institutes of Health (NIH), has initiated
a Phase 1 safety study of AVANT�s investigational single-dose, oral
vaccine designed to offer combined protection against both
enterotoxigenic Escherichia coli (ETEC) and cholera. ETEC infection
is a major cause of travelers� diarrhea. The study, a randomized
double-blind, placebo-controlled, in-patient Phase 1 trial
conducted in up to 64 adult volunteers, will examine the safety and
immunogenicity of a single dose of the ETEC-Cholera vaccine,
designated Peru-15 pCTB, at up to four escalating dose levels
compared against placebo. The Principal Investigator, Dr. Mitchell
B. Cohen, M.D., will conduct the study at the Cincinnati Children�s
Hospital Medical Center. �We are very pleased that NIAID has chosen
to fund this initial study of our combination ETEC-cholera
vaccine,� said Anthony S. Marucci, AVANT Immunotherapeutics Interim
President and Chief Executive Officer. �This vaccine builds on the
clinical successes to date of our single-dose, oral typhoid fever
and cholera vaccines, and represents the next important milestone
towards our goal of developing a safe, oral, rapid-acting �super
enteric� vaccine that combines protection against multiple diseases
in a single product.� The Peru-15 pCTB vaccine is derived from the
same cholera strain (Peru-15) as AVANT�s cholera vaccine,
CholeraGarde�. CholeraGarde has been shown to be well tolerated and
provide protective levels of immunity in studies involving over 400
vaccinees. The Peru-15 pCTB vaccine re-engineers the Peru-15 strain
to produce additional, key antigens that provide protection against
the ETEC bacterium, thus potentially adding protection against
travelers� diarrhea. Preclinical animal studies with the
investigational combination vaccine have shown it to be highly
immunogenic. ETEC is a major cause of enteric disease among
travelers, military personnel and those who live in developing
countries where the disease is endemic. Market research studies
conducted with travel medicine clinics have shown a strong
preference for a combined vaccine compared to either ETEC or
cholera vaccines given separately. About AVANT Immunotherapeutics,
Inc. AVANT Immunotherapeutics, Inc. is a NASDAQ-listed company
discovering and developing innovative vaccines and targeted
immunotherapeutics for the treatment of cancer, infectious and
inflammatory diseases. AVANT focuses on the use of tumor-specific
targets and human monoclonal antibodies (mAbs) to precisely deliver
therapeutic agents through its novel �targeted immunization�
approach. AVANT also possesses innovative bacterial vector delivery
technologies with unique manufacturing and preservation processes
that offer the potential for a new generation of infectious disease
vaccines. AVANT�s deep product pipeline consists of products in
varying stages of development, with its lead candidate, CDX-110,
partnered with Pfizer, Inc., currently undergoing evaluation in a
Phase 2b/3 clinical trial in newly diagnosed glioblastoma
multiforme, one of the most aggressive forms of brain cancer. AVANT
also has five product candidates in its development pipeline
including: CDX-1307, a product based on its proprietary APC
Targeting Technology�, which is in two Phase 1 clinical trials for
patients with advanced pancreatic, bladder, breast and colon
cancer; TP10, a complement inhibitor, in development for
transplantation and other indications; and Three candidates based
on its oral, rapidly-protecting, single-dose and temperature-stable
vaccine technology, including combination vaccines for travelers,
the military and global health needs. AVANT has three
commercialized products, including Rotarix� for the prevention of
rotavirus infection and two human food safety vaccines for reducing
salmonella infection in chickens and eggs. Additional information
on AVANT Immunotherapeutics, Inc. can be obtained through our site
on the World Wide Web: http://www.avantimmune.com. About NIAID and
the NIH NIAID is a component of the National Institutes of Health.
NIAID supports basic and applied research to prevent, diagnose and
treat infectious diseases such as HIV/AIDS and other sexually
transmitted infections, influenza, tuberculosis, malaria and
illness from potential agents of bioterrorism. NIAID also supports
research on basic immunology, transplantation and immune-related
disorders, including autoimmune diseases, asthma and allergies. The
National Institutes of Health (NIH)�The Nation's Medical Research
Agency�includes 27 Institutes and Centers and is a component of the
U. S. Department of Health and Human Services. It is the primary
federal agency for conducting and supporting basic, clinical and
translational medical research, and it investigates the causes,
treatments and cures for both common and rare diseases. For more
information about NIH and its programs, visit http://www.nih.gov
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 successful
integration of the businesses, multiple technologies and programs
of AVANT and Celldex; (2)the ability to adopt AVANT�s APC Targeting
TechnologyTM to develop new, safe and effective vaccines against
oncology and infectious disease indications; (3) the ability to
adapt AVANT�s vectoring systems to develop new, safe and effective
orally administered vaccines against disease causing agents; (4)
the ability to successfully complete product research and further
development, including animal, pre-clinical and clinical studies,
and commercialization of CDX-110, CDX-1307, CholeraGarde�
(Peru-15), Ty800, ETEC E. coli vaccine, and other products and
AVANT�s expectations regarding market growth; (5) the cost, timing,
scope and results of ongoing safety and efficacy trials of CDX-110,
CDX-1307, CholeraGarde� (Peru-15), Ty800, ETEC E. coli vaccine and
other preclinical and clinical testing; (6) the ability to
negotiate strategic partnerships or other disposition transactions
for AVANT�s cardiovascular programs, including TP10 and CETi; (7)
the ability of AVANT to manage multiple clinical trials for a
variety of product candidates; (8)�the volume and profitability of
product sales of Megan�Vac 1, Megan�Egg and other future products;
(9)�the process of obtaining regulatory approval for the sale of
Rotarix� in major commercial markets, as well as the timing and
success of worldwide commercialization of Rotarix� by our partner,
GlaxoSmithKline or Glaxo; (10)�Glaxo�s strategy and business plans
to launch and supply Rotarix� worldwide, including in the U.S. and
other major markets and its payment of royalties to AVANT; (11)
Pfizer�s and our strategy and business plans concerning the
continued development and commercialization of CDX-110; (12)
AVANT�s expectations regarding its technological capabilities and
expanding its focus to broader markets for vaccines; (13) changes
in existing and potential relationships with corporate
collaborators; (14) 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; (15) the timing, cost and uncertainty of obtaining
regulatory approvals; (16) AVANT�s ability to develop and
commercialize products before competitors that are superior to the
alternatives developed by such competitors; (17) AVANT�s ability to
retain certain members of management;(18) AVANT�s expectations
regarding research and development expenses and general and
administrative expenses; (19) AVANT�s expectations regarding cash
balances, capital requirements, anticipated royalty payments
(including those from Paul Royalty Fund), revenues and expenses,
including infrastructure expenses; (20)�the ability to obtain
substantial additional funding; (21) AVANT�s belief regarding the
validity of our patents and potential litigation; and (22) 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 current 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.
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