Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. RiVax™ is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.
The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders that affect fewer than 200,000 individuals within the United States. In addition to providing a seven-year term of market exclusivity for RiVax™ upon FDA approval, Orphan Drug Designation also positions Soligenix to be able to take advantage of certain financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of a Biologics License Application for RiVax™, and certain tax credits.
RiVax™ induces a protective immune response in animal models of ricin exposure and is currently being evaluated in humans. A human Phase 1A clinical trial of RiVax™ has been completed and a Phase 1B clinical trial remains ongoing. Results of the Phase 1A clinical trial of RiVax™ indicated that the immunogen was safe and induced antibodies anticipated to protect humans from ricin exposure. The outcome of the study was published in the Proceedings of the National Academy of Sciences (Vitetta et al., 2006, PNAS, 105:2268-2273). The Phase 1B trial, sponsored by University of Texas Southwestern Medical Center in Dallas (UT Southwestern), is currently evaluating a more potent formulation of RiVax™. Soligenix has developed processes for large-scale manufacturing of the vaccine product and is developing the product using animal models for efficacy under the FDA animal rule. RiVax™ was invented by Ellen Vitetta, PhD, Director of the Cancer Immunobiology Center and colleagues at UT Southwestern.
"The FDA's decision to grant RiVax™ Orphan Drug Designation for the prevention of ricin intoxication marks another important step forward in our biodefense pipeline," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "Marketing exclusivity through Orphan Drug Designation adds significantly to the existing patent estate surrounding RiVax™. We are enthusiastic about the prospects of developing a ricin vaccine to anticipate civilian and military biodefense requirements and for potential government stockpiling."
Korean fermented food Doenjang shows promise in alleviating menopausal symptoms