Celsion reports favorable safety profile of higher dose of GEN-1 in ovarian cancer

Celsion (CLSN -1.7%) reports that the Independent Data Safety Monitoring Board has completed its initial safety review of data from the first 15 ovarian cancer patients who received the first four neoadjuvant doses of DNA-based immunotherapy GEN-1 at 100 mg/m² in the ongoing Phase 1/2 OVATION 2 study, the highest dose yet assessed.

In six evaluable patients, no dose-limiting toxicities were observed. GEN-1, administered intraperitoneally, was well-tolerated when given with neoadjuvant chemo (NACT). After the six have completed interval debulking surgery, the company will report surgical results and overall tumor response rates for all 15 Phase 1 subjects later this quarter.

The safety of up to 17 weekly doses of GEN-1 will be evaluated before the Phase 2 portion will be initiated. Unless something unexpected happens, enrollment should commence next quarter, expected to be completed in Q1 2021.

https://seekingalpha.com/news/3539296-celsion-reports-favorable-safety-profile-of-higher-dose-of-genminus-1-in-ovarian-cancer