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Soligenix Announces Publication of Positive Stability Results with RiVax(TM), its Vaccine Against Ricin Toxin
Date:2/2/2010

PRINCETON, N.J., Feb. 2 /PRNewswire-FirstCall/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biotechnology company, announced today the publication of an article in the February 2010 edition of Vaccine, which describes preclinical formulations of RiVax™, its ricin toxin vaccine, with heightened stability. The article was authored by the Company's collaborators at the University of Texas Southwestern Medical Center at Dallas (UT Southwestern) where the vaccine originated. RiVax™ is currently being evaluated in Phase 1 human safety and immunogenicity trials, as well as non-human primate trials for efficacy.

The purpose of this study was to establish preliminary conditions for long-term stability of RiVax™ with the intent of avoiding the cold chain usually required for storage of vaccines. In this publication, a series of formulations of the RiVax™ immunogen, a modified recombinant ricin A chain protein, were examined for comparative effects of storage at room temperature versus refrigeration. The formulations were designed with excipients expected to add to protein stability and then processed by lyophilization to remove water. One combination of lyophilization conditions and excipients was found to result in a vaccine that retained immunogenicity in animals, an index of vaccine potency, for one year at room temperature (the longest time tested). The lead formulation showed no evidence of degradation, whereas unstable control formulations aggregated when reconstituted with water. Moreover, the stabilized vaccine formulation was potent when adsorbed to aluminum hydroxide adjuvant, which is used in many approved vaccines. As shown previously, the aluminum adjuvant enhanced the immunogenicity and potency of RiVax™. The lyophilized vaccin
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