Princeton, NJ September 15, 2011 Soligenix, Inc.
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Princeton, NJ – September 15, 2011 – Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced that an independent Data Safety Monitoring Board (DSMB) recently completed a pre-specified interim analysis for safety and futility for Soligenix's confirmatory Phase 3 clinical trial of orBec ® an oral formulation of beclomethasone dipropionate (BDP) in acute gastrointestinal Graft-versus-Host disease (GI GVHD).
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.
http://www.soligenix.com/news.aspx?titleId=375
People panicked, and it took a big dump. Company is still moving on, and presently valued at just about cash on hand.
Dr. Schaber continued, “With approximately $7.4 million of cash, we can continue 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 TM , 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.”