|Celsion Shares Moving Higher on Findings from ThermoDox HEAT Study; EnteroMedics Closes VBLOC Therapy Pre-PMA Meeting with FDA|
|By Staff and Wire Reports|
|Friday, 17 May 2013 19:52|
Celsion Corporation (NASDAQ: CLSN) announced 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.
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that the Company completed a pre-PMA (Premarket Approval) application meeting with the U.S. FDA on May 15, 2013 regarding the Maestro(R) Rechargeable System's VBLOC(R) vagal blocking therapy as a treatment for obesity.
In the meeting, the FDA indicated that, subject to acceptance of the application and validation and detailed review of the submitted data by the FDA, the Company can anticipate presenting the PMA before a future FDA Advisory Committee panel. The Company expects to submit a PMA for the Maestro Rechargeable System, based on the ReCharge Pivotal Trial, in the second quarter of 2013.
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