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news.Celsion, an oncology drug development company, has initiated enrollment in the Phase I/II open label, dose escalating Dignity trial to evaluate the safety and efficacy of ThermoDox with hyperthermia for the treatment of recurrent chest wall breast cancer, an aggressive form of cancer with a poor prognosis and limited treatment options.
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The first patient treated in the Dignity trial was at Rhode Island Hospital by principal investigator Brigid O’Connor. The other clinical sites participating in the trial include: the Florida Cancer Institute in Hudson, Florida led by principal investigator Arthur Maztkowitz, the New York University Hospital in New York, New York led by Silvia Formenti, and the Cancer Treatment Center of America in Tulsa, Oklahoma led by Petra Ketterl.
The primary endpoint in the Dignity trial is durable complete local response at the tumor site. Celsion intends to enroll 100 patients in the US by the first quarter of 2010.
The results from the Dignity trial are expected to build on the promising data from the Phase I dose escalation study currently being conducted at Duke University Medical Center.
Michael Tardugno, president and CEO of Celsion, said: “We anticipate that we will complete enrollment in the Dignity study by the first quarter of 2010, as patients with RCW breast cancer have limited, effective treatment options and are motivated to find new alternatives. We believe that we have funds sufficient to fully enroll this important trial and we look forward to reporting the results when they become available.”