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 most recent analysis of this data shows a 2.1-year 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 Study—GEN-1 in ovarian cancer
OVATION is 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 is determination of a recommended phase II dose of GEN-1 in combination with standard neoadjuvant therapy. It has a standard 3+3 design with approximate 30% dose increments between successive cohorts of patients.
EU-DIGNITY Study of ThermoDox in recurrent chest wall breast cancer
The EU-DIGNITY Study is designed to assess the effectiveness and tolerability of targeted, heat-activated therapy (radiotherapy + hyperthermia + LTSL doxorubicin) in loco-regional relapse of breast cancer. There will be 70 patients enrolled in the study throughout Europe and Israel. This study is designed based on results from the phase 2 DIGNITY Study completed in the United States with 17 patients in 5 centers. The study showed compelling clinical activity, with a local response rate of 47%, including 5 complete responses and 3 partial responses. Additionally, 18% of DIGNITY study participants have experienced disease stabilization. Those findings are consistent with the local response rate of 48.3% observed in 24 patients enrolled in 2 previous phase 1 studies.