Breast Cancer
Celsion to Proceed with Phase II Pivotal Breast Cancer Trial after Receiving Supportive FDA Response
Published in Oncology Business Week, February 3rd, 2008
CELSION CORPORATION (AMEX: CLN) announced that it had received a supportive written response from the FDA in relation to its proposed registrational study for use of ThermoDox in patients with recurrent breast cancer at the chest wall. With these FDA responses, Celsion now believes it has established a Phase II protocol which has defined acceptable endpoints in a defined patient population that has an unmet medical need. Celsion intends to proceed with its plans for initiating the Phase II study in the second half of 2008. It is anticipated that the open label study will enroll up to a maximum of 100 patients in approximately ten US centers.
Mr. Michael H. Tardugno,...
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