Celsion Corporation (CLSN)

[BioSpecialist]

CLSN IS ON THE MOVE ::::::::::::::::::

Big US-PartnerShip is coming very soon ....

Celsion (CLSN)

Market Cap: 38 Mio$
Cash: 14,1 Mio$
Price: 3,15 $

Shares Out: 12,1 M

Huge Pipeline
http://www.celsion.com/pipeline.cfm


"We continue to make substantive progress in our Phase III HEAT trial for ThermoDox with over 45% of the 600 patients now enrolled in the study," said Michael Tardugno, President and CEO of Celsion. "With the recent addition of China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and Italy, we expect enrollment completion within the next 2 quarters. We have achieved our goal of opening enrollment at 60 clinical trial sites world-wide, and we anticipate initiating the trial at an additional 10 sites by the end of this month. Additionally, our pivotal Phase recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a sufficient number of patients in the Phase I portion to warrant a dose escalation review by the DSMB. Assuming there will be no adverse events suggesting dose limiting toxicity, the Dignity Study may be allowed to increase dosage to the therapeutic dose as early as March of this year."




Data Monitoring Committee Recommends Continuation of Celsion's Phase III ThermoDox(R) Study for Primary Liver Cancer
270 patients treated in Phase III trial at 60 sites in 11 countries

COLUMBIA, Md., Feb 10, 2010 /PRNewswire via COMTEX News Network/ -- Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox(R) clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.

The DMC for the HEAT study is comprised of an independent group of medical and scientific experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DMC reviews safety data at regular intervals with the mandate to ensure patient safety and monitor the quality and overall conduct of the study. The study design and statistical plan for the Phase III ThermoDox trial also incorporates a pre-planned interim efficacy analysis by the DMC after patient enrollment is complete, with the intent to stop the study if there is overwhelming evidence of treatment benefit or an extremely low probability of treatment success.

"We are pleased that the DMC has recommended continuation of the study based on its review of the safety data," stated Michael H. Tardugno, President and Chief Executive Officer of Celsion. "We currently have 60 sites enrolling patients in 11 countries and plan to have 70 sites with patients by the end of February. With recent acceleration in patient recruitment, and the study now nearly 50% enrolled, we project that the trial will be fully enrolled within the next two quarters."

Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival.