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DOR BioPharma announces positive phase 1 results of RiVax vaccine
By Lisa Kerner
Erie, Pa., Jan. 30 - DOR BioPharma, Inc. said results of a phase 1 safety and immunogenicity dose-escalation study of RiVax, a recombinant vaccine against ricin toxin, indicate that the vaccine is well tolerated and induces antibodies in humans that neutralize ricin toxin.
The pilot phase 1 trial marks the first time a ricin toxin vaccine has been clinically tested in humans, the company said.
The trial enrolled 15 volunteers in groups of 5 who were vaccinated with three successive monthly injections of the same dose level of RiVax. Three dose levels of RiVax were evaluated. RiVax without an adjuvant, induced antibodies in all five of the individuals who received the highest dose, four out of five who received the intermediate dose, and one out of five who received the lowest dose levels.
Antibodies were present in the blood of several volunteers for as long as 127 days after their last vaccination.
The study was completed at the University of Texas Southwestern Medical Center, led by Dr. Ellen Vitetta. Study outcomes will be published this week in the online edition of the Proceedings of the National Academy of Sciences.
Ricin toxin is a potential bioterror threat due to its highly lethal toxicity in small doses. Exposure to small amounts can lead to rapid lung damage if inhaled, nausea, fever, and abdominal pain if ingested, and general organ failure leading to death within several days. Currently there is no Food and Drug Administration-approved vaccine against ricin toxin, the company said.
DOR BioPharma, based in Miami, is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments.
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