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 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, orBec® (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 orBec® 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 www.cambrex.com.
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