Soligenix, Inc — Department of Health and Human Services SBIR Phase II: NIDCR

Description

Project Summary Abstract This proposal supports the conduct of the clinical study IDR OMentitledA PivotalDouble BlindRandomizedPlacebo ControlledMultinational Study of SGXDusquetidefor the Attenuation of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and NeckThis trial is designed to confirm the positive findings seen in the SBIR Phase IRDEsupported study IDR OMentitledA PhaseDouble BlindRandomizedPlacebo ControlledDose RangingMulticenter Study of SGXfor the Attenuation of Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and NeckOral mucositisOMis a serious and debilitating condition and currently an unmet medical need for patients and physiciansIt has a significant impact on patient quality of life and outcomes during cancer therapy as well as having a significant pharmacoeconomic costThere are no currently approved drugs to treat OM in patients with non hematological malignanciesincluding head and neck cancerHNCSevere OMi eWHO gradesoris the most clinically important form as they have the potential to result in alterations to a patient s cancer therapyOM has been linked to the dysregulation of the innate defense systemresulting in an inflammatory cascadewhich amplifies damage to the mucosal lining leading to clinically overt mucositisDusquetidethe active pharmaceutical ingredient in SGXis an Innate Defense RegulatorIDRwhich binds to the pproteina key adaptor protein which functions downstream of most innate immune receptorsSGXhas received Fast Track Designation from the FDA validating it has demonstrated the potential to address this unmet medical needSGXcan address both acute trauma and acute infectionsand SGXmay have some independent direct anti tumor activity via its activity in the innate immune systemThis Phase II proposal seeks to conduct a study to confirm that SGXmg kg dusquetideis an efficacious therapy for chemoradiation therapyCRTinduced severe OM in patients with HNCallowing for better long term cancer related outcomesIf successfulresults from this study will support marketing authorization applications worldwideincluding a New Drug ApplicationNDAsubmission to the FDAThe Specific Aims of this proposal areSpecific AimConfirm the efficacy ofmg kg SGXcompared to placebo in reducing the duration of severe oral mucositisSOMin patients receiving CRT for their oral cavity or oropharyngeal squamous cell carcinomaSpecific AimConfirm the safety of this immunomodulator in HNC patients including the lack of interference with chemoradiation treatment outcomestumor progression and mortalityand the lack of an increased infection rate withmg kg SGXtreatment compared to placebo