Celsion Provides Summary of Research and Development Day Held on Thursday, October 12, 2017
The presentations focused on the Company's research and development program using ThermoDox®, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin, for the treatment of primary liver cancer, also known as hepatocellular carcinoma or HCC. Leading OPTIMA Study clinical investigators representing various geographical regions (
- ThermoDox's mechanism of action and how it utilizes tumor biology to deliver high concentrations of drug (Doxorubicin) directly to the tumor site and the importance of heating time.
- Key learnings from the Company's 701 patient HEAT Study including results from (i) computer simulation studies, (ii) preclinical animal studies and (iii) a post hoc subgroup analysis, all of which establishes a clear understanding of a key ThermoDox® heat-based mechanism of action: the longer the target tissue is heated, the greater the doxorubicin tissue concentration.
- Hypothesis prompted by the HEAT Study post-hoc findings: ThermoDox®, when used in combination with Radiofrequency Ablation (RFA) standardized to a minimum dwell time of 45 minutes (sRFA > 45 min), appears to increase the overall survival (OS) of patients with HCC.
Results from an independent retrospective analysis conducted by the
National Institutes of Healthon the intent-to-treat population of the HEAT Study which sought to evaluate the correlation between RFA burn time per tumor volume (min/ml) and clinical outcome. The analysis concluded that increased RFA "burn time" per tumor volume significantly improved overall survival (OS) in patients with solitary lesions treated with sRFA + ThermoDox® compared to patients treated with sRFA alone.
- Update on the current enrollment status of the OPTIMA Study which is approaching 70% of the 550 patients necessary to ensure that its primary end point, overall survival, can be evaluated with statistical significance. The statistical plan for the OPTIMA Study calls for two interim efficacy analyses by the
IDMC. The Company projects full patient enrollment by mid-2018 and the first pre-planned efficacy analysis after 118 overall survival events by the first quarter of 2019.
- RFA has limited efficacy in larger tumors due to microsatellite nodules or viable tumors.
- Patients treated with ThermoDox® in the HEAT Study had excellent survival outcome. Two cases presented for the HEAT Study showed five and nine year survival benefit for patients treated with ThermoDox® plus sRFA.
- HEAT Study patients treated with ThermoDox® demonstrated a high complete response rate compared to other studies
- A strong correlation exists between complete response and better survival.
- HCC is a worldwide problem with high incidence that continues to rise.
- Treatment strategies for treating HCC should be tailored.
- Until ThermoDox®, RFA was insufficient in treating intermediate to large tumors.
- Data from the HEAT Study suggests a new role for RFA plus ThermoDox® in HCC - a "promising option."
About the OPTIMA Study
The Phase III OPTIMA Study is expected to enroll up to 550 patients in up to 70 clinical sites in
ThermoDox® has received
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