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Vaccine Researchers Combat Biothreat Agents
Preclinical Safety Testing Aims to Reduce the Deadly
Effects of Ricin Toxin
MENLO PARK, Calif.– July 5, 2005 – SRI International, an
independent nonprofit research and development organization, today announced
it is working with DOR BioPharma, Inc. (AMEX: DOR) and Cambrex Corporation (NYSE:
CBM) to develop a recombinant vaccine, RiVaxT, for protection against exposure
to the ricin toxin, a potential biothreat agent. In September 2004, the National
Institute of Allergy and Infectious Diseases (NIAID), a unit of the National
Institutes of Health, awarded DOR BioPharma a Challenge Grant for process development,
scale-up and cGMP manufacturing of RiVax.
DOR BioPharma licensed the potential vaccine, which is a nontoxic modification
of the ricin toxin, from the University of Texas Southwestern Medical Center
in Dallas. DOR recently announced positive interim results from its ongoing
Phase I clinical trial of RiVax, which is the first ricin toxin vaccine to be
clinically tested in humans. The NIAID grant awarded to DOR BioPharma
supports process development and large-scale manufacturing being conducted by
Cambrex. SRI will optimize the immune response to the vaccine and perform preclinical
safety testing to meet requirements of the U.S. Food and Drug Administration
(FDA) for efficacy and safety studies.
"SRI's considerable expertise in preclinical drug development will
help move this potentially life-saving vaccine further into the clinical-trial
stage," said Rae Lyn Burke, Ph.D., director of the SRI Center of Excellence
for Infectious Disease and Biodefense. "The availability of a ricin
vaccine would greatly reduce the threat of this extremely toxic substance."
SRI is a leading provider of preclinical development services for anti-infective
therapeutics and vaccines. SRI holds major contracts with NIAID for
conducting preclinical safety and pharmacokinetic studies. Under separate
NIAID grants, SRI's Biosciences Division is also testing potential smallpox
and HIV vaccines. SRI also works with the National Cancer Institute
(NCI) and numerous private biotechnology companies on development of
vaccines and anti-infective therapeutics.
About SRI International's Biosciences Division
SRI's Biosciences Division (www.sri.com/biosciences) is a unique organization
that operates like a research-driven pharmaceutical and biotechnology
company, a technology incubator, and a full-service preclinical contract
research organization, with all of the resources necessary to take chemical
and biological discovery and development programs from "idea to
IND". More than 10 therapeutic products have been advanced to human
clinical trials based on internal research conducted at SRI.
Through collaboration with other divisions at SRI, Biosciences is also
creating technical platforms for the next generation of drug discovery
in areas such as bio-computation and real-time diagnostics. Biosciences'
preclinical contract research organization (CRO) services include basic
research, target validation, lead discovery and optimization, radiochemical
synthesis, in vitro and in vivo efficacy testing, formulation, in vitro
toxicology screening, good laboratory practices (GLP) safety pharmacology
and toxicology, pharmacokinetics, metabolism, good manufacturing practices
(GMP) work with clinical trial materials, quality assurance, and IND
preparation and submission.
About SRI International
Silicon Valley-based SRI International ( www.sri.com ) is one of the
world's leading independent research and technology development organizations.
Founded as Stanford Research Institute in 1946, SRI has been meeting
the strategic needs of clients for almost 60 years. The nonprofit research institute performs contract research and development for government agencies, commercial businesses and private foundations. In addition
to conducting contract R&D, SRI licenses its technologies, forms
strategic partnerships and creates spin-off companies.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company focused on the development
of biodefense vaccines and therapeutics for areas of unmet medical needs. Through
its BioDefense Division, DOR is developing bioengineered vaccines designed to
protect against the deadly effects of ricin toxin and botulinum toxin, both
of which are considered serious bioterrorism threats. DOR's ricin toxin vaccine,
RiVax TM , is currently the subject of a Phase I clinical trial in normal volunteers.
DOR also recently announced the initiation of a new botulinum toxin therapeutic
development program based on rational drug design. DOR's lead therapeutic product,
orBecŪ (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid
being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD),
a common serious complication of bone marrow transplantation for cancer, as
well as other gastrointestinal disorders characterized by severe inflammation.
DOR intends to file a new drug application (NDA) with the FDA for orBecŪ for
the treatment of iGVHD later this year.
For further information regarding DOR BioPharma, please visit the Company's
website located at www.dorbiopharma.com.
About Cambrex Corporation
Cambrex is a global, diversified life sciences company dedicated
to providing products and services to accelerate and improve the discovery
and commercialization of human therapeutics. The Company employs
approximately 1900 worldwide. For more information, please visit
http://www.cambrex.com.
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