Anti-TGF-Beta Antisense AP 12009 Shows Very Good Safety and Tolerability in Systemic Treatment of Pancreatic Carcinoma, Malignant Melanoma and Colorectal...( CHICAGO and REGENSBURG Germany Ju...),Health

CHICAGO and REGENSBURG, Germany, June 2 /PRNewswire/ -- The TGF-beta 2 inhibitor AP 12009, developed by Antisense Pharma, reveals very good safety and tolerability in the systemic treatment of pancreatic carcinoma, malignant melanoma and colorectal carcinoma. AP 12009, administered intravenously, showed a clear proof of concept. Patients with stage IV pancreatic carcinoma, who received AP 12009 for seven days every other week as second or third line therapy, had a median survival time of 29.6 weeks (6.8 months) after start of AP 12009 treatment. One of these patients with several liver metastases even experienced a complete response. Efficacy and safety results of the multicenter Phase I/II study were published today at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, USA (1).

In the open-label, multicenter, dose-escalation Phase I/II study patients with advanced stage pancreatic carcinoma, malignant melanoma or colorectal carcinoma were included. So far 25 patients have been treated in six cohorts. The first four cohorts received AP 12009 as 7-day on, 7-day off cycles. For this schedule, the maximum tolerated dose (MTD) was reached with two grade III thrombocytopenias as dose-limiting toxicities (DLT). These were self-limiting and required no therapeutic intervention. The third DLT was a grade III rash. Thus, the compound AP 12009 revealed excellent safety and tolerability. Very encouraging case reports were observed. One patient, diagnosed with stage IV malignant melanoma, survived more than 60 weeks after the start of AP 12009 treatment. Another patient with stage IV pancreatic carcinoma and several liver metastases had a complete response and is still alive as of March 2008 148 weeks (34 months) after the start of treatment with AP 12009.

After reaching the MTD with the 7-day on, 7-day off schedule, a second schedule with 4-day on, 10-day off cycles was initiated. Two cohorts with a total of seven patients h
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