UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): September 15, 2011
Commission File No. 000-16929
Soligenix, Inc.
(Exact name of small business issuer as specified in its charter)
DELAWARE
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41-1505029
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(State or other jurisdiction of incorporation or organization)
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(I.R.S. Employer Identification Number)
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29 Emmons Drive,
Suite C-10
Princeton, NJ
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08540
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(Address of principal executive offices)
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(Zip Code)
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(609) 538-8200
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(Issuer’s telephone number, including area code)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
Pursuant to a pre-specified interim analysis for safety and futility for Soligenix, Inc.’s confirmatory Phase 3 clinical trial of orBec® in the treatment of acute gastrointestinal Graft-versus-Host disease (“GI GVHD”), the Data Safety Monitoring Board (the “DSMB”) on September 14, 2011 reported their recommendation to Soligenix. The DSMB recommended that the study be stopped as it is highly unlikely to achieve the predetermined primary objective of efficacy based on the interim results. No safety concerns were raised. As a result of the DSMB’s recommendation, patient enrollment in the study will stop and the data will be analyzed.
Item 9.01.Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press release issued by Soligenix, Inc. on September 15, 2011.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Soligenix, Inc.
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September 15, 2011
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By:
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/s/ Christopher J. Schaber |
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Christopher J. Schaber, Ph.D. |
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President and Chief Executive Officer (Principal Executive Officer) |
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