The Food and Drug Administration has granted Fast Track designation to RiVax® (heat stable ricin toxin vaccine; Soligenix) for the prevention of ricin intoxication.
Ricin is a plant-derived toxin that could potentially be used as a biological weapon. Exposure to even a small dose of the toxin can cause tissue necrosis and general organ failure within several days.
RiVax contains a genetically altered version of a ricin toxin A (RTA) chain containing 2 mutations that inactivate the toxicity of the ricin molecule. A phase 1B clinical trial of an alum-adjuvanted RiVax formulation found that the vaccine provided 100% protection against acute exposure to aerosolized ricin in 12 rhesus macaque (P <.0001). According to the Company, heat stabilization of the vaccine resulted in enhanced stability and the ability to withstand temperatures at least as high as 104 degrees Fahrenheit for up to 1 year.
“We believe that the FDA’s action in granting Fast Track designation validates the unmet medical need that currently exists for a vaccine providing protection against lethal ricin toxin exposure and for the potential key role RiVax can serve as a part of the US Strategic National Stockpile,” said Christopher J. Schaber, PhD, CEO of Soligenix.
The Fast Track designation makes the application eligible for priority review, which would reduce the review time to 6 months.
For more information visit Soligenix.com.