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
GEN-1 Manufacturing Technology Transfer Successfully Produces High-Quality Affordable Investigational Product for Use in Clinical Trials
The OVATION 2 Study is a randomized Phase I/II study designed to evaluate the safety of 100 mg/m² of GEN-1 in the Phase I portion, followed by a continuation at the safe dose in the Phase II portion in an open-label, 1:1 randomized design. GEN-1, designed using
In the OVATION 2 Study, patients in the GEN-1 treatment arm will receive GEN-1 plus chemotherapy pre- and post-interval debulking surgery. The OVATION 2 Study will enroll up to 130 patients with Stage III/IV ovarian cancer, with 12 to 15 patients in the Phase I portion and up to 118 patients in the Phase II portion. The study is powered to show a 33% improvement in progression-free survival (PFS), the primary endpoint, when comparing GEN-1 with NACT versus NACT alone. The PFS primary analysis will be conducted after at least 80 events (or deaths) have been observed, or after all patients have been followed for at least 16 months, whichever is later.
Developed with extensive input from the Company's
"This latest DSMB review of GEN-1 at 100 mg/m² confirmed that there were no dose limiting toxicities detected in any of the five patients dosed with GEN-1 and that intraperitoneal administration is well tolerated even when given with standard NACT," said
Dr. Borys concluded, “OVATION 2 is designed to define the optimal dose of GEN-1 and provide important insights into GEN-1's clinical benefit as an adjuvant therapy both before and after debulking surgery with the potential to stimulate an anticancer immune response, compared to the current standard of care alone."
In the prior Phase Ib OVATION I Study,
“We are very excited to advance our ovarian cancer research, which is based on the known and highly potent anti-cancer agent IL-12. We believe GEN-1, our novel, gene-mediated formulation, has the potential to effectively harness IL-12’s antitumor activity for cancer patients with a dimension of safety not found in the free, recombinant form,” said
Manufacturing Technology Transfer for GEN-1
In order to support the future clinical development and global market strategy of GEN-1 in ovarian cancer, the Company is finalizing technology transfer initiatives with two premier global manufacturers in
Key provisions of the technology transfer initiatives are as follows:
- To provide
Celsionwith a high-quality, affordable, cost-effective supply for all global markets.
- To target unit costs for clinical supplies of GEN-1 that are substantially competitive with the Company's current suppliers.
- Once an approved drug, the cost structure for GEN-1 is expected to support rapid market adoption and significant gross margins across global markets.
About Celsion Corporation
|Celsion Investor Contact||LHA Investor Relations|
|Jeffrey W. Church||Kim Sutton Golodetz|
|Executive Vice President, CFO and Corporate Secretary|
Source: Celsion CORP