Celsion Corporation (NASDAQ:CLSN) confirms Positive Interim Data from Phase 2 DIGNITY Study in Breast Cancer, Shares Up 22% Print
By Josh Gee   
Wednesday, 15 April 2015 15:11

Celsion Corporation (NASDAQ:CLSN)’s shares soared 22% to $3.24 as the company has come out with positive interim data from the ongoing open-label Phase 2 DIGNITY Trial of ThermoDox in the recurrent chest wall (RCW) breast cancer. 

This treatment is made for enrolling close to 20 patients at a number of U.S. clinical sites and is assessing ThermoDox combined with mild hyperthermia.

There were 12 patients who could be evaluated on the efficiency from the 16 patients enrolled and treated. While 67% of patients experienced clinical benefit whereas there was local response rate of 58% observed in the 12 evaluable patients.

The firm is on track for completing enrolment in the quarter three of 2015.

Dr. Nicholas Borys, Celsion's Senior Vice President and Chief Medical Officer, stated that the tumor response data which includes 5 complete responses from Phase 2 DIGNITY study are superb especially because the patients in trial had highly resistant chest wall tumors which had improved on a number of therapies including chemotherapy, as well as radiation.

He added that along with Phase 1 studies data, the results accentuate the vital potential of ThermoDox along with hyperthermia for stabilising disease in the difficult-to-treat patient population.

Michael H. Tardugno, Celsion's chairman, president and CEO, opined that the firm is leveraging the data from the ThermoDox program in RCW breast cancer for expediting development as well as commercialization of ThermoDox in the indication in Europe.

He added that the strength of DIGNITY data is moving investigator interest in Europe along with forming the foundation for Euro-DIGNITY trial that would be starting later in the quarter.

The CEO added that the company is committed on providing patients suffering from bad form of breast cancer with access to ThermoDox along with continuing work closely with myTomorrows for launching an Early Access Program in Europe for ThermoDox in RCW breast cancer.


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