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Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial of SGX942 in the Treatment of Oral Mucositis in Head and Neck Cancer
PRINCETON, N.J., April 18, 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., April 18, 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 that it has reached a significant milestone in the Phase 3 clinical study (the \"DOM-INNATE\" study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC). Patient enrollment is sufficient to support the planned interim efficacy analysis by the independent Data Monitoring Committee (DMC).\nIn accordance with the clinical protocol, approximately 90 subjects have been enrolled into the study as required for the planned interim efficacy analysis. In the coming weeks, subjects that are currently enrolled will have their protocol assessments completed at participating study centers, including the primary endpoint assessment. The blinded data will be verified for accuracy by the Soligenix clinical team and the data set will be provided to an independent statistical analysis center that interacts directly with the DMC for the interim efficacy analysis. All participating subjects and study centers, as well as the Company, will remain blinded at all times. \nThe DMC is a group, independent of the Company, charged with safety oversight of the clinical study as well as the conduct of one, pre-specified interim efficacy analysis. One DMC member is a statistician, with the remainder consisting of clinicians knowledgeable and experienced in the disease indication being studied. The DMC convenes at pre-determined intervals (in accordance with a pre-defined charter) to review unblinded safety and efficacy data. The DMC has the power to recommend continuation or termination of the study based on the evaluation of these data. Specific recommendations include stopping the study for overwhelming efficacy, stopping the study for serious safety concern, stopping the study for futility, continuing enrollment in the study at the pre-specified sample size of approximately 190 subjects, or re-estimating sample size up or down to maintain the study's statistical power. \n\"Completing the required enrollment to support the DMC interim analysis is a significant milestone for the SGX942 program,\" stated Christopher J. Schaber, PhD, Presiden...