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Soligenix Reports Year-End 2011 Financial Results and Highlights Recent Accomplishments
Date:3/27/2012

y plus one week. The primary objective of the study was to evaluate the safety and tolerability of escalating doses of SGX201, as well as to assess the preliminary efficacy of SGX201 for prevention of signs and symptoms of acute radiation enteritis. This study demonstrated that oral administration of SGX201 was safe and well tolerated across all four dose groups.  There was also evidence of a potential dose response with respect to diarrhea, nausea and vomiting and the assessment of enteritis according to NCI Common Terminology Criteria for Adverse Events for selected gastrointestinal events. In addition, the incidence of diarrhea was lower than that seen in recent published historical control data in this patient population.
  • On February 6, 2012, the Company announced results from preclinical studies of its proprietary vaccine thermostabilization technology, ThermoVax™, indicating its ability to produce stable vaccine formulations using adjuvants, protein immunogens, and other components that ordinarily would not withstand long temperature variations exceeding customary refrigerated storage conditions. These studies were conducted with Soligenix's aluminum-adjuvanted ricin toxin vaccine, RiVax™, made under precise lyophilization conditions using excipients that aid in maintaining native protein structure of the ricin A chain, the immunogenic compound of the vaccine. When RiVax™ was kept at 40 degrees Celsius for over one month, all of the animals vaccinated with the lyophilized RiVax™ vaccine developed potent and high titer neutralizing antibodies. In contrast, animals that were vaccinated with the liquid RiVax™ vaccine kept at 40 degrees Celsius did not develop neutralizing antibodies and were not protected against ricin exposure. The ricin A chain is extremely sensitive to temperature and rapidly loses the ability to induce neutralizing antibodies when exposed to temperatures higher than 8 degrees Celsius.  

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