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Vaccine Researchers Combat Biothreat Agents; Preclinical Safety Testing Aims to Reduce the Deadly Effects of Ricin Toxin.


MENLO PARK, Calif. -- SRI International, an independent nonprofit research and development organization, today announced it is working with DOR BioPharma, Inc. (AMEX AMEX

See: American Stock Exchange
:DOR) and Cambrex Corporation (NYSE NYSE

See: New York Stock Exchange
:CBM CBM Commodore Business Machines
CBM Coalbed Methane
CBM Christoffel Blindenmission
CBM Condition Based Maintenance
CBM Confidence-Building Measures
CBM Curriculum Based Measurement (education)
CBM Cubic Meter
) to develop a recombinant vaccine, RiVax(TM), for protection against exposure to the ricin toxin, a potential biothreat agent. In September 2004, the National Institute of Allergy and Infectious Diseases (NIAID NIAID National Institute of Allergy and Infectious Diseases. ), 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 Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I
 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) 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 ricin /ri·cin/ (ri´sin) a phytotoxin in the seeds of the castor oil plant (Ricinus communis), used in the synthesis of immunotoxins.

ri·cin
n.
 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 See Liberate. ) 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/pharma) 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 In vitro toxicology is the scientific analysis of the effects of toxic chemical substances on cultured bacteria or mammalian cells. In vitro (literally 'in glass') testing methods are employed primarily to identify potentially hazardous chemicals and/or to confirm  screening, good laboratory practices (GLP See gateway location protocol. ) safety pharmacology and toxicology, pharmacokinetics, metabolism, good manufacturing practices (GMP GMP (guanosine monophosphate): see guanine. ) 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 Stanford Research Institute - Former name of SRI International.  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 nonprofit 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(R) (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 Bone Marrow Transplantation Definition

The bone marrow—the sponge-like tissue found in the center of certain bones—contains stem cells that are the precursors of white blood cells, red blood cells, and platelets.
 for cancer, as well as other gastrointestinal disorders characterized by severe inflammation. DOR intends to file a new drug application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) with the FDA for orBec(R) 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.
COPYRIGHT 2005 Business Wire
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Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 5, 2005
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