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Soligenix Announces Positive Recommendation by Independent Data Monitoring Committee on its Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer
PRINCETON, N.J., Aug. 28, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":" PRINCETON, N.J., Aug. 28, 2019 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today it has received a positive recommendation from the independent Data Monitoring Committee (DMC) to continue enrolling into the company's Phase 3 \"DOM–INNATE\" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC). Following its prospectively defined interim analysis, including unblinded assessment of the study's primary efficacy endpoint, the DMC recommended that approximately 70 additional subjects be randomized into the trial, increasing the study sample size from 190 to 260 evaluable subjects. The DMC's recommendation indicates that a beneficial SGX942 effect has been observed; however, to maintain the rigorous assumption of 90% statistical power for the primary efficacy endpoint, an increase was required to take into account any potential variability and/or distribution changes observed in the Phase 3 study patient population that may have differed from the initial protocol design assumptions. No safety concerns were reported by the DMC based on the interim analysis. The study remains on target to complete enrollment and provide topline results in the first half of 2020. \n\"We are pleased to have received the DMC's recommendation to continue enrolling to the adjusted target of 260 subjects in order to maintain our conservative power calculation,\" stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. \"Since reaching the 90 subject enrollment threshold required for the conduct of the interim analysis in April, we currently have over 160 subjects enrolled in the study. With this new level of clarity from the DMC's analysis of the interim Phase 3 study data and given our current rate of patient enrollment, we are confident that we will remain on target to announce topline results in the first half of 2020. We have invested a significant amount of the Company's resources over the last several years into the oral mucositis development program and it is gratifying to have received this feedback from t...