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Soligenix Announces Results of Recent Data Safety Monitoring Board Review for Phase 3 orBec® Study in Acute GI GVHD
Date:9/15/2011

e to evaluate other clinical applications for oral BDP in the areas of radiation enteritis, radiation injury, and Crohn's disease. With continued additional funding under our $9.4 million NIH grant, we can also continue to pursue development of our heat stabilization technology for subunit vaccines including application to RiVax™, our vaccine against ricin toxin. Additionally, we will be instituting cost containment measures as we evaluate our strategic options, including whether to further pursue the applications of orBec® in the GVHD treatment and prevention space in light of the results of the recent Phase 3 clinical trial."

The Company will host a webcast and conference call today at 9AM EDT to review the DSMB recommendation. To participate in the conference call, please dial the following toll free number: (877) 407-3974. International callers may dial: (201) 689-8886. After prepared remarks by management, a question-and-answer session will follow. Listeners may also participate via webcast approximately 10 minutes prior to the start of the call by visiting the Soligenix website investor relations page at http://www.soligenix.com/invest_sec.shtml. The webcast is best viewed using Internet Explorer.

About orBec®

orBec®, oral beclomethasone dipropionate (oral BDP), was recently the subject of a confirmatory Phase 3 clinical trial in the treatment of acute GI GVHD which was stopped for futility. This Phase 3 trial, also referred to as the SUPPORTS protocol (Sparing Unnecessary Prednisone Phase 3 orBec® Randomized Treatment Study), enrolled 140 patients and was designed to confirm the clinically meaningful endpoints observed in previous Phase 2 and Phase 3 clinical studies. The primary endpoint was the treatment failure rate at Study Day 80. Analysis of this endpoint was positive as a secondary
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Related medicine technology :

1. Soligenix Announces Publication of Positive Stability Results with RiVax(TM), its Vaccine Against Ricin Toxin
2. Soligenix Announces Publication of Positive Pre-Clinical Results with RiVax(TM), Its Vaccine Against Ricin Toxin
3. Soligenix Announces Initiation of a Phase 1/2 Clinical Trial of SGX201 for the Prevention of Acute Radiation Enteritis
4. Soligenix Forms Consortium to Develop Thermostable Technology to Advance RiVax(TM) and Other Rapidly Acting Vaccines
5. Soligenix Announces Issuance of Hong Kong Patent for its LPM(TM) Oral Drug Delivery Technology
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7. Soligenix to Present at the OneMedForum Conference on Wednesday, June 30 at 2PM EDT
8. Soligenix Announces Award of $1.2 Million FDA Orphan Products Development Grant
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10. Soligenix Announces Preliminary Results of its Phase 2 Clinical Trial of orBec® in the Prevention of Acute GVHD
11. Soligenix Announces Positive Preliminary Results of SGX202 in Radiation Injury
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