Celsion Announces the Potentially Curative Approach to Treatment of Primary Liver Cancer - The Focus of Hepatic Oncology Peer-Reviewed Article
Ongoing Phase III Trial to Confirm Hypothesis That The Combination of Standardized Radio
Frequency Ablation (sRFA) Plus Lyso-Thermosensitive Liposomal Doxorubicin (LTLD) May
Substantially Increase Survival of Patients with HCC Compared to sRFA Alone
"There is an urgent need for new and better treatment options for HCC, the sixth most common cancer in the world, and the third most common cause of death from malignant disease," noted
Interest in ThermoDox® as a potential treatment option for HCC increased markedly among liver cancer experts worldwide following the announcement by
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,
"We are highly focused on successfully executing the ongoing OPTIMA study, the only global study in HCC,"
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
The primary endpoint for the OPTIMA Study is overall survival (OS). The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC). The design of the OPTIMA Study is supported by the retrospective analysis of a large subgroup of 285 patients in the Company's previous 701 patient HEAT Study in primary liver cancer. The study is also designed to establish a clear path to approval in major liver cancer markets worldwide, with results from the OPTIMA Study, if successful, providing the basis for a global registration filing and marketing approval.
About LTLD (ThermoDox®)
Celsion's most advanced program is a heat-mediated, tumor-targeting drug delivery technology that employs a novel heat-sensitive liposome engineered to address a range of difficult-to-treat cancers. The first application of this platform is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD), whose novel mechanism of action delivers high concentrations of doxorubicin to a region targeted with the application of localized heat at 40°C, just above body temperature. In one of its most advanced applications, LTLD, when combined with radiofrequency thermal ablation (RFA), has the potential to address a range of cancers. For example, RFA in combination with ThermoDox® has been shown to expand the "treatment zone" with a margin of highly concentrated chemotherapy when treating individual primary liver cancer lesions. The goal of this application is to significantly improve efficacy.
Celsion's LTLD technology leverages two mechanisms of tumor biology to deliver higher concentrations of drug directly to the tumor site. The first: Rapidly growing tumors have leaky vasculature, which is permeable to liposomes and enables their accumulation within tumors. Leaky vasculature influences a number of factors within the tumor, including the access of therapeutic agents to tumor cells. Administered intravenously, LTLD is engineered with a half-life to allow significant accumulation of liposomes at the tumor site as these liposomes recirculate in the blood stream. The second: When an external heating device heats the tumor tissue to a temperature of 40°C or greater, the heat-sensitive liposome rapidly changes structure and the liposomal membrane selectively dissolves, creating openings that release the chemotherapeutic agent directly into the tumor and into the surrounding vasculature. Drug concentration increases as a function of the accumulation of liposomes at the tumor site, but only where the heat is present. This method damages only the tumor and the area related to tumor invasion, supporting precise drug targeting.
Celsion Investor ContactSource:
Jeffrey W. ChurchSr. Vice President and CFO 609-482-2455 firstname.lastname@example.org Celsion Media Contacts Harriet ShelareDirector, Communications 860-483-1721 email@example.com Bill BerryBerry & Company 212-253-8881 firstname.lastname@example.org
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