OPTIMA Study of ThermoDox® in primary liver cancer
The OPTIMA study, launched in the second half of 2014, is a global, phase 3 clinical study designed to evaluate ThermoDox in combination with standardized RFA (sRFA ≥45) in primary liver cancer . The 2-arm, double-blind, placebo-controlled, randomized study will enroll approximately 550 patients at up to 75 sites in North America, Europe, China, and the Asia-Pacific region. The primary endpoint is overall survival (OS). The study is powered to demonstrate a 33% improvement in OS.
The OPTIMA study design is based on sub-group analysis from the HEAT(Hepatocellular Carcinoma Study of RFA and ThermoDox®) study. The final analysis of this data shows a median 20-month improvement in OS in patients with single lesions, 3-7 cm in size, that were treated with ThermoDox plus RFA ≥45 minutes vs RFA alone ≥45 minutes.
OVATION Studies—GEN-1 in ovarian cancer
OVATION 2 is a Phase I/II study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer. The primary objective of the study is to evaluate safety and compare progression free survival between neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT. This is a randomized, open label, multicenter trial in which eligible subjects will be assigned 1:1 to the treatment and control arms. The phase I portion of the study will determine the dosing for the phase II portion, which will also evaluate safety, efficacy, and biological activity.
OVATION was a Phase I Study of the Safety & Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed with Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. The primary endpoint was determination of a recommended phase II dose of GEN-1 in combination with standard neoadjuvant therapy. It had a standard 3+3 design with approximate 30% dose increments between successive cohorts of patients.