Celsion Announces First Patient Randomized in the Gene-Mediated Immunotherapy (GEN-1) Study of Newly Diagnosed Stage III/IV Ovarian Cancer Patients
OVATION II Study Will Evaluate Initial and Maintenance Dosing of GEN-1 on Progression-Free Survival in a Two-Arm, Randomized Trial of Up to 130 Patients
"In previous studies, GEN-1 was shown to be well tolerated at doses up to 79 mg/m2 with meaningful, dose-dependent, pro-immune clinical activity,” said Dr.
OVATION II is a Phase I/II study designed with a single dose escalation phase to 100 mg/m² of GEN-1 in the Phase I portion, followed by a continuation at the selected dose in Phase II, in an open-label, 1:1 randomized design. In OVATION II, patients in the GEN-1 treatment arm will receive GEN-1 plus chemotherapy pre- and post-debulking surgery. OVATION II will include up to 130 patients with Stage III/IV ovarian cancer, with 12 patients in the Phase I portion and up to 118 patients in Phase II, at ten U.S. medical centers. The study is powered to show a 33% improvement in the primary endpoint, PFS, when comparing GEN-1 with adjuvant chemotherapy versus adjuvant chemotherapy alone. The PFS primary analysis will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later. Under the open-label design, clinical data will be disclosed throughout the execution of the trial as it is released by the study's investigators.
Developed with extensive input from the company's
“We are very excited to advance our ovarian cancer research, the foundation of which is based on a known anti-cancer agent, IL-12. Over the past three decades, IL-12 has convincingly demonstrated its capability to actively recruit the body's immune system to work against cancers. However, its clinical promise has been limited by a poor safety profile. GEN-1 has the potential to address this. In our novel, gene-mediated formulation, we believe GEN-1 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
About GEN-1 Immunotherapy
GEN-1, designed using
About Celsion Corporation
Argot Partners Sam Martin212-600-1902 Sam@argotpartners.com
Source: Celsion CORP