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Celsion Gains on Impressive Breast Cancer Study Data - Analyst Blog

Celsion CorporationCLSN was up approximately 18.6% after the company announced encouraging interim data from its ongoing open-label phase II DIGNITY study on ThermoDox for recurrent chest wall (RCW) breast cancer.

The study is evaluating ThermoDox in combination with mild hyperthermia. Based on available data, 67% of patients experienced a clinical benefit of their highly refractory disease with a local response rate of 58% observed in the 12 evaluable patients. Additionally, 5 patients experienced complete responses, 2 partial responses and 1 stable disease. The company expects to complete enrollment in the DIGNITY study in the third quarter of 2015. The study is expected to be completed later this year.

Based on data from the DIGNITY study, the company expects to initiate the Euro-DIGNITY study later this quarter. The Euro-DIGNITY study will evaluate the use of ThermoDox and hyperthermia in patients suffering from RCW breast cancer. Data from the study, if positive, will enable the company to submit regulatory application in Europe.

We note that Celsion has a license and distribution agreement with myTomorrows to implement an Early Access Program (EAP) for ThermoDox in the EU and Switzerland for the treatment of RCW breast cancer patients. The company expects ThermoDox to be available shortly for sales at commercial prices to physicians who are treating patients with limited therapeutic options.

The company is also evaluating ThermoDox for the treatment of primary liver cancer (phase III).

Celsion carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care space are Cytokinetics, Incorporated CYTK , Valeant Pharmaceuticals International, Inc. VRX and Affymetrix Inc. AFFX . While Valeant and Affymetrix hold a Zacks Rank #1 (Strong Buy), Cytokinetics is a Zacks Rank #2 (Buy) stock.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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