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Re: concordia post# 75316

Wednesday, 09/20/2017 3:28:08 PM

Wednesday, September 20, 2017 3:28:08 PM

Post# of 144817
These are the only trials ever conducted with CIAB and are clearly stated in current 10k.


Phase 1/2 Clinical Trial

Dates of Trial and Location : This clinical trial was opened on July 28, 1998 and closed on September 20, 1999. It was carried out at the Division of Gastroenterology, University of Rostock, Germany.

Identity of Trial Sponsors : The clinical trial was sponsored by Bavarian Nordic.

Trial Design : The clinical trial was an open-label, prospective, single-arm and single center trial.

Patient Information : A total of 17 patients were enrolled in the clinical trial (51 were screened). A total of 14 patients were treated because two of the original 17 patients developed severe infections before the start of the clinical trial and had to be treated by other means. For the other patient, angiography was not successful, causing the patient to be disqualified from participating in the clinical trial.

Phase 2 Clinical Trial

Location of Trial : The clinical trial was opened on November 16, 1999 and closed on December 1, 2000. This clinical trial was carried out at four centers in two countries in Europe. These were in Berne, Switzerland, and in Rostock, Munich and Berlin, Germany.

Trial Sponsor : The clinical trial was sponsored by Bavarian Nordic.

Trial Design : This was an open-label, prospective, single-arm multi-site study.

Patient Information : All 13 patients enrolled in the trial were treated. Twelve patients exhibited Stage IV disease. The remaining patient had Stage III disease. Ten of the 13 patients exhibited metastases.
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