First Human Clinical Trials of a Ricin Toxin Vaccine
DOR Biopharma Reports Ricin Vaccine in Phase I Clinical Trial
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DOR Biopharm announced that DOR and its academic partner began human testing of RiVax(TM), a recombinant vaccine designed to protect against ricin toxin. After having successfully passed prerequisite animal safety and efficacy evaluations, RiVax(TM) (recombinant ricin toxin vaccine) is the first ricin vaccine to be tested in humans.
The Phase I trial is a dose escalating trial in which volunteers will receive three monthly intramuscular doses of vaccine. Three cohorts of five volunteers each will receive low, medium, or high doses of RiVax(TM). Blood from the volunteers will be tested for ricin neutralizing antibodies prior to each injection and regularly for six months, with the final measure of immunogenicity/effectiveness one year after the first injection. The trial is designed to confirm that the vaccine is safe at doses that induce ricin neutralizing antibodies. The Company expects that preliminary interim safety and immunogenicity data will be available as early as the second quarter 2005.
DOR is developing RiVax(TM) pursuant to the FDA's 'animal rule' adopted in May 2002, which provides an expedited path to regulatory approval for biodefense products based upon sufficient demonstration of safety in humans with hypothetical efficacy demonstrated in animals. As part of the Phase I clinical trial, if sufficient immunogenicity is achieved in humans, DOR intends to isolate ricin specific antibodies from the human volunteers and transfer them to animal models to test the human antibodies' effectiveness in protecting the animals from ricin toxin exposure.
Given its FDA-approved Investigational New Drug Application (IND) and initial human dosing, DOR has made substantial progress in preparing for a potential procurement contract from the U.S. Government for the manufacture and delivery of investigational vaccines to the U.S. Strategic National Stockpile. The recently enacted BioShield Act of 2004 permits the U.S. Government to procure and purchase biodefense countermeasures, such as RiVax(TM), while still investigational and prior to FDA regulatory approval.
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Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous