Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products, has granted orphan drug designation to the Company's recombinant modified ricin toxin A-chain subunit (the active pharmaceutical ingredient in RiVax®) for the prevention of ricin poisoning. RiVax® has previously been granted orphan drug designation from the US Food and Drug Administration (FDA).
The European Commission grants orphan designations for medicines that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union (EU) and where no satisfactory treatment is available. In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan drug designation provides incentives for companies seeking protocol assistance from the EMA during the product development phase, and direct access to the centralized authorization procedure which allows access to all 28 EU member states' markets.
"We are extremely pleased to have received European orphan drug designation for the RiVax® program," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, Inc. "This EU orphan designation, combined with our US orphan designation, positions this biodefense program for a potentially accelerated global regulatory product development pathway to address this unmet need. RiVax®has shown up to 100% protection against aerosolized ricin exposure in non-human primates and safety in humans and we look forward to further developing our thermostable formulation for human use."
About Ricin Toxin
Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact 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 it needs. 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.
About RiVax®
RiVax® is Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin. With RiVax®, Soligenix is a world leader in the area of ricin toxin vaccine research.
RiVax® contains a genetically altered version of a ricin toxin A-chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax® that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax® induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.
To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax® was subsequently formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. T...
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