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Microcap & Penny Stocks : Celsion (CLN AMEX) was CELN

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From: Saulamanca	1/15/2008 12:37:51 PM
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Celsion to Proceed with Phase II Pivotal Breast Cancer Trial after Receiving Supportive FDA Response Tuesday January 15, 9:17 am ET Expects to Initiate Trial in Ten US Centers COLUMBIA, Md.--(BUSINESS WIRE)--CELSION CORPORATION (AMEX: CLN - News) today 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, Celsion’s President and Chief Executive Officer added, “The response from the FDA confirms our belief and that of our medical consultants that this is a patient population with an unmet medical need. Accordingly, with appropriate supporting data, we may be able to seek an early approval for ThermoDox for this indication, and are designing this Phase II as a Pivotal Study.” ThermoDox is currently involved in a Phase I Dose escalation study at Duke University. This study continues to enroll patients and show promising data as previously reported at the WICO/STM meeting in Washington and the ESHO in Prague in early 2007. The study is currently in the process of being expanded to include an additional site with the intent of accelerating study enrollment. Duke University Medical Center is currently enrolling patients in the Phase I study. Patients who may be interested in enrolling in the study should contact the Duke Protocol office at (919) 660-1278 or visit the Duke hyperthermia website at hyperthermia.mc.duke.edu.

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