Celsion Corporation (CLSN)

[sdtrond]

Re: Japan:

See http://investor.celsion.com/releasedetail.cfm?ReleaseID=549437

"The Company further announced that the DMC has maintained its recommendation to continue withholding enrollment of additional patients in Japan pending certain guidance from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. The recommendation follows a review of safety data from 18 Japanese patients enrolled in the study, when compared to patient data from the rest of the Phase III trial. As a part of its commitment to Japan's PMDA, the DMC independently assesses patients randomized at Japanese sites. As previously noted, overall toxicities for patients in the HEAT study are consistent with doxorubicin's labeled safety profile. Doxorubicin, the active therapeutic in ThermoDox®, is a widely used chemotherapeutic with a well known safety profile and approved globally for use, including Japan, in many cancer indications. "

Please note the second to last sentence, "As previously noted, overall toxicities for patients in the HEAT study are consistent with doxorubicin's labeled safety profile."

The best guess here is simply the standard of care differences are too great for valid comparisons. RFA in Japan evidently comprises a much longer stay in the hospital that it does elsewhere, with much closer monitoring. Thus, we'd have a huge collection of headaches, fatigue, nausea, etc listed as AEs compared to other countries. They were very careful to say the overall AEs were comparable to known dox, though.