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Celsion Corp. Message Board

  • clsn_bounce_starts_now clsn_bounce_starts_now May 17, 2013 8:32 AM Flag

    Overall Survival improved by 66% (Hazard Ratio of 0.602) when compared to the control arm of RFA treatment only.

    The press release is out now.

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    • 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.
      •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.
      •When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a Pvalue = 0.105

      • 1 Reply to canstic1
      • 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.•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. •When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a Pvalue = 0.105

    • 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.
      •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.
      •When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a Pvalue = 0.105.

    • 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.
      •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.
      •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.
      •When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a Pvalue = 0.105.
      •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.
      •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.

    • 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.
      •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.
      •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.
      •When combined, these two subgroups show clinical results that indicated a 53% improvement in Overall Survival, a Hazard Ratio of 0.65, and a Pvalue = 0.105.
      •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.
      •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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