Celsion Announces FDA Clearance of the OVATION II Study for the Evaluation of GEN-1 Immunotherapy to Treat Newly Diagnosed Stage III/IV Ovarian Cancer
Celsion Corporation (CLSN)
Last celsion corporation earnings: 11/14 04:05 pm
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Source: GlobeNewswire
GEN-1 to Enter the Clinic in Mid-2018 Following a Phase IB Trial Which Demonstrated 100% Disease Control, 86% Objective Response Rate and 86% R0 & R1 Surgical Resection Rate in All Patients Treated Compelling Progression-Free Survival Data from Phase IB Trial Supports Development of GEN-1 as a Novel First Line Neoadjuvant Therapy LAWRENCEVILLE, N.J., Jan. 04, 2018 (GLOBE NEWSWIRE) -- Celsion Corporation (NASDAQ: CLSN), an oncology drug development company, today announced that the U.S. Food and Drug Administration (FDA), following the customary 30 day review period, has accepted its submission without comment, providing clearance for the OVATION II Study, the Company’s planned Phase I/II clinical trial of GEN-1, its DNA-based immunotherapy for the localized treatment of ovarian cancer. The Phase I/II trial was developed with extensive input from the Company’s Medical Advisory Board. The OVATION II Study builds on the highly promising clinical and translational research data
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