Credit: Shutterstock photoCelsion CorporationCLSN reported encouraging interim data from its ongoing phase II DIGNITY study on ThermoDox for recurrent chest wall (RCW) breast cancer. The study is evaluating ThermoDox in combination with mild hyperthermia.
13 of the 17 enrolled patients were eligible for the evaluation of efficacy. Based on available data, every patient on ThermoDox was reported to demonstrate clinical benefit of their highly refractory disease with a local response rate of 69% observed in the evaluable patients. Additionally, five patients experienced complete responses, four experienced partial responses and four experienced stable disease. The company expects to complete enrollment in the phase II DIGNITY study in the third quarter of 2015.
Meanwhile, the company is looking to start treating the first patient in the EURO-DIGNITY study soon. EURO-DIGNITY will evaluate the use of ThermoDox plus hyperthermia and radiation in earlier stage breast cancer patients. If positive, data from the study will enable the company to submit a regulatory application in Europe.
We note that Celsion entered into a license and distribution agreement with myTomorrows in Jan 2015, to implement an Early Access Program for ThermoDox in the EU and Switzerland for the treatment of RCW breast cancer patients.
The company expects ThermoDox to be available shortly at commercial prices to physicians who are treating patients with limited therapeutic options.
Apart from the breast cancer study, ThermoDox is in the phase III OPTIMA study for the treatment of primary liver cancer.
Celsion currently carries a Zacks Rank #3 (Hold). INSYS Therapeutics, Inc INSY , China Biologic Products, Inc. CBPO and Eleven Biotherapeutics, Inc. EBIO are better-ranked stocks in the health care sector, each sporting a Zacks Rank #1 (Strong Buy).
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