Note: As discussed in the Hepatic Oncology article, the hypothesis tested in the HEAT Study was that ThermoDox® would produce a therapeutic doxorubicin tumor concentration when combined with the normal practice of RFA, thereby expanding the ‘treatment zone' and targeting any micro-metastases outside the so-called ‘ablation zone.' The criterion for RFA use in the HEAT Study was limited to ablation of each target lesion plus a 360° 1-cm margin, however; it included no attempt to manage RFA approach or RFA dwell time, despite the essential role of heat in the LTLD mechanism of action.
To test and confirm this most current HEAT Study post hoc subgroup analysis, Celsion initiated the Phase III OPTIMA study, a global, pivotal, double-blind, placebo-controlled clinical trial (Clinical Trials.gov NCT021126560). Developed in consultation with leading primary liver cancer, statistical and regulatory experts, and based on extensive analysis of prior clinical and preclinical studies of ThermoDox® plus standardized RFA, the OPTIMA study is now evaluating ThermoDox® in combination with RFA standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone.
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"We are highly focused on successfully executing the ongoing OPTIMA study, the only global study in HCC," Mr. Tardugno stated. "We look forward to sharing our progress with the scientific community as we continue to advance this program, and to accomplishing our chief goal, the delivery of ThermoDox® as a novel, first-line treatment to HCC patients worldwide."
The OPTIMA Study
OPTIMA, a pivotal, double-blind, placebo-controlled Phase III clinical trial, is expected to enroll up to 550 patients at up to 75 sites in the North America, Europe, China and Asia Pacific. As of June 2016, the study has been successfully enrolling patients at more than 50 clinical sites in 13 different countries in North America, Europe and Asia Pacific. In December 2015, Celsion announced that it had received a Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the OPTIMA Study at up to 20 additional clinical sites in China, the country where approximately 50% of the 850,000 new cases of primary liver cancer are diagnosed each year and where the Company aims to enroll more than 200 patients in the China territory, the minimum number required by the CFDA to file a New Drug Application (NDA), assuming positive clinical results.
