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Soligenix Announces Publication of Positive Pre-Clinical Results with RiVax(TM), Its Vaccine Against Ricin Toxin
Date:12/28/2009

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RiVax(TM) is Soligenix's proprietary vaccine developed to protect against exposure to ricin toxin and is the most advanced vaccine in the company's portfolio. RiVax(TM) induces a protective immune response in animal models of ricin exposure and is currently being evaluated in humans. One human Phase 1 clinical trial has been completed and a second trial is currently being conducted.

Results of the first Phase 1 clinical trial of RiVax(TM) established 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 second trial, sponsored by the University of Texas Southwestern Medical Center (UTSW), is currently evaluating a more potent formulation of RiVax((TM)). Soligenix has developed processes for large-scale manufacturing and is further establishing correlates of the human immune response in nonhuman primates.

The development of RiVax(TM) has been sponsored through a series of overlapping challenge grants (UC1) and cooperative grants (U01) from NIH, granted to Soligenix and to UTSW where the vaccine originated. The second clinical trial is being supported by a grant to UTSW from the US Food and Drug Administration's Office of Orphan Products Development. Soligenix and UTSW have collectively received approximately $25 million in grant funding from the NIH for development of RiVax(TM) and related vaccine technologies.

About Ricin Toxin

Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency, as well as the large worldwide reservoir created as a by-product of castor oil production. Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure. The potential use of ricin toxin as a biological
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SOURCE Soligenix, Inc.
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