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Celsion Corporation
announced today that Professor Riccardo Lencioni, MD, FSIR, EBIR, 2013
WCIO Program Chairman and the Director of the Division of Diagnostic Imaging
and Intervention at Pisa University School of Medicine in Italy and Lead
European Principal Investigator for the HEAT Study and Professor Ronnie T.P.
Poon, MD, MS, PhD, FRCS(Edin), FACS, Professor of Surgery at the University of
Hong Kong and Lead Asia Pacific Principal Investigator for the HEAT Study
conducted separate scientific discussions reviewing the clinical trial results
from the Company's Phase III HEAT Study including new emerging findings from
the HEAT Study post-hoc analysis at the 9^th Annual Meeting of the World
Conference on Interventional Oncology, which is being held on May 16 to 20,
2013 in New York City. The new post-hoc findings suggest that optimized
heating cycles markedly improve radiofrequency ablation (RFA) plus ThermoDox's
potential for clinically relevant improved progression free survival (PFS) and
Overall Survival (OS) outcomes. Professors Poon and Lencioni both concluded
that the findings warrant further investigation and development of ThermoDox
as a first line treatment for HCC when combined with RFA. The slide
presentations are available on the Events and Presentations page on the
Celsion website.
The data from the HEAT Study post-hoc analysis presented by Professors
Lencioni and Poon demonstrate that ThermoDox markedly improves PFS and OS in
patients with a single lesion if their lesions undergo RFA for 45 minutes or
more. These findings apply to HCC lesion regardless of size and represent a
subgroup of approximately 300 patients or 42% of the patients in the HEAT
Study. The post-hoc analysis completed by the Company to-date indicates that
there may be a large patient cohort that benefited from RFA plus ThermoDox
regardless of lesion size.
o In the patient subgroup treated in the ThermoDox arm whose RFA procedure
lasted longer than 45 minutes and was completed within 90 minutes (40% of
single lesion patients), Overall Survival improved by 66% (Hazard Ratio of
0.602) when compared to the control arm of RFA treatment only.
o In the patient subgroup treated in the ThermoDox arm whose RFA procedure
lasted longer than 90 minutes (23% of single lesion patients), Overall
Survival almost doubled (Hazard Ratio of 0.508) when compared to the
control arm of RFA treatment only.
o When combined, these two subgroups show clinical results that indicated a
53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a
P[value] = 0.105.
o In contrast, the patient subgroup treated with ThermoDox whose RFA
procedure lasted less than 45 minutes in duration (37% of single lesion
patients) indicated that the control arm had an improved Overall Survival
benefit when compared to the ThermoDox arm.
o The Hazard Ratios reported above should be viewed with caution since they
are not statistically significant and the HEAT Study has not reached its
median point for Overall Survival analysis. Celsion will continue
following all patients enrolled in the HEAT Study to the secondary
endpoint, Overall Survival, and update its subgroup analysis based on RFA
heating duration.
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