Celsion Announces DSMB Recommendation to Continue GEN-1 at 100mg/m² Dose to Complete the Phase I Portion of OVATION 2 Study in Ovarian Cancer
Celsion Corporation (CLSN)
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Source: GlobeNewswire
GEN-1 Manufacturing Technology Transfer Successfully Produces High-Quality Affordable Investigational Product for Use in Clinical Trials LAWRENCEVILLE, N.J., Nov. 05, 2019 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN) today announced that the independent Data Safety Monitoring Board (DSMB) has completed its safety review of data from the first eight patients enrolled in the ongoing Phase I/II OVATION 2 Study. Based on the DSMB's recommendation, the study will continue as planned and the Company will proceed with completing enrollment in the Phase I portion of the trial. The OVATION 2 Study combines GEN-1, the Company's IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly diagnosed patients with Stage III and IV ovarian cancer who will undergo standard neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS). The OVATION 2 Study is a randomized Phase I/II study designed to evaluate the safety of 100 mg/m² of GEN-1 in
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