Soligenix announced its RiVax® (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).
Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics. For instance, should events warrant, Soligenix will be eligible to submit a biologics license application (BLA) for RiVax® on a rolling basis, permitting the FDA to review sections of the BLA prior to receiving the complete submission. Additionally, BLAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.
"We are very pleased to have been granted fast track designation from the FDA to go along with the orphan drug designation previously received," said Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "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."
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The development of RiVax® has been funded through a series of grants from both the National Institute of Allergy and Infectious Diseases (NIAID) and the FDA and ongoing development is sponsored by NIAID. Non-dilutive funding for the development of RiVax® has exceeded $40 million to date.
Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact that it is readily extracted from by-products of castor oil production. Ricin comes in many forms including powder, mist or pellet. Ricin can also be dissolved in water and other liquids. The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt. Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure. Ricin is especially toxic when inhaled. Ricin works by entering cells of the body and preventing the cells from making the proteins they need. Without the proteins, cells die, which is eventually harmful to the entire body.
There are currently no effective treatments for ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used to vaccinate military personnel and civilian emergency responders at high risk of potential exposure in the event of a biological attack.