Munich, Germany – TRION Pharma GmbH today announced positive results of a Phase I trial in which trifunctional antibody catumaxomab was administered intraoperatively to patients with advanced gastro-intestinal cancers. The treatment was well tolerated and safe and led to substantial tumor cell destruction.
In the trial, a total of 12 patients undergoing surgery for advanced EpCAM positive gastrointestinal (GI) tumors received 5 escalating doses of catumaxomab. The first dose was given intraperitoneally during surgery immediately after tumor resection, while the 4 remaining doses were administered intraperitoneally on day 7, 10, 13, and 16 after surgery. To assess preliminary efficacy, the secondary endpoint, tumor cell destruction was monitored by immunocytochemical analysis of peritoneal lavages and tumor recurrence was monitored by endoscopy and CT scans.
Intraoperative treatment was well tolerated up to 20 microgram of catumaxomab without dose limiting toxicities. Tumor cell destruction was assessed in 8 patients, and in 5 of these patients a substantial decrease of tumor cells in peritoneal lavage was recorded 24 hours after intraoperative treatments. No patient had local intraperitoneal tumor recurrence or peritoneal carcinomatosis during mean follow-up of 14.3 months.
“We are very happy about the outcome of the study as we now see that the intraoperative administration of our trifunctional antibody catumaxomab is safe and feasible”, said Horst Lindhofer, CEO of TRION Pharma. “The results once again underline the potential of catumaxomab to destroy tumor cells in a very effective and fast manner. We are now looking forward to the results of further studies evaluating the intraoperative administration of catumaxomab." At present, the intraoperative application of catumaxomab is tested in two Phase II studies in gastric cancer patients as well as in a Phase II study in ovarian cancer patients.
“Usually, the prognosis of patients with advanced gastrointestinal cancer is quite poor, as these tumors spread very fast”, added Dr Michael Ströhlein, consultant surgeon at the Department of Abdominal Surgery at the University of Witten-Herdecke and lead author of the study. “We are now confident that intraoperative immunotherapy with catumaxomab may offer promising new treatment options in GI cancers - not only for the destruction of intraperitoneal tumor cells but also for the prevention of tumor cell spread and cancer recurrence.”
Results of the study were presented at the 2008 Gastrointestinal Cancers Symposium in Orlando/FL, U.S.A.