Celsion Corporation (NASDAQ: CLSN) announced the randomization of the first two patients in the Phase II portion of the OVATION 2 Study for GEN-1, targeting advanced ovarian cancer. The study aims to enroll 118 patients to evaluate GEN-1's impact combined with standard neoadjuvant chemotherapy. Initial Phase I results showed an R0 resection rate of 87.5% in GEN-1 treated patients, compared to 50% in NACT-only patients. Celsion has received orphan designations for GEN-1 in both the U.S. and Europe, providing potential market exclusivity.
Celsion Corporation (NASDAQ: CLSN) received a recommendation from the Data Monitoring Committee to consider halting the Phase III OPTIMA Study, examining ThermoDox® for treating hepatocellular carcinoma. The DMC found the study unlikely to meet its primary endpoint of overall survival with a p-value of 0.524. Despite this, no safety issues were identified. Celsion plans a thorough review of unblinded data before deciding the study's future. The OPTIMA Study included 554 patients at 65 sites globally. A conference call is scheduled for July 15 to discuss findings.
Celsion Corporation (NASDAQ: CLSN) announced the closure of a public offering, selling 2,666,667 shares of common stock and generating $9.3 million in net proceeds. The funds will be allocated for clinical development, working capital, and general corporate needs. The offering was conducted under an effective registration statement with the SEC. Oppenheimer & Co. Inc. served as the sole underwriter. Celsion develops innovative cancer treatments, focusing on its lead program, ThermoDox®, currently in Phase III trials for primary liver cancer.
Celsion Corporation (NASDAQ: CLSN) announced a public offering of 2,666,667 shares at $3.75 each, expected to raise approximately $10 million before expenses. The offering, aimed at both existing and new institutional investors, is set to close on June 24, 2020. Proceeds will support clinical development and general corporate purposes. Oppenheimer & Co. Inc. is the sole underwriter. This offering is made under an effective shelf registration statement filed with the SEC. Forward-looking statements indicate risks that may affect actual outcomes compared to expectations.
Celsion Corporation (NASDAQ: CLSN) announced favorable findings from the Phase I portion of the OVATION 2 Study with GEN-1 for advanced ovarian cancer. The Data Safety Monitoring Board recommended advancing to Phase II with a 100 mg/m² dose due to satisfactory safety and tolerability, with patients capable of receiving up to 17 doses. The study showed a 78% complete tumor resection rate in the GEN-1 group versus 50% in the control. Celsion is optimistic about the therapy's potential and plans to initiate Phase II enrollment in Q4 2020.