Ganymed Pharmaceuticals AG, a biopharmaceutical company developing Ideal Monoclonal Antibodies (IMABs) for the treatment of cancer, announced that it has completed recruitment of 210 patients for its Phase 2 FAST clinical trial to evaluate the combination of IMAB362 and chemotherapy as first-line therapy in patients with gastroesophageal cancer (GEC). Top line results from this trial are expected end 2015/early 2016.
“Completion of recruitment of this clinical trial represents a key achievement towards our mission of providing cancer patients with safe and effective new therapies. Current therapies show limited effectiveness in only a small fraction of GEC patients and are linked to side effects. By contrast, IMAB362 has the potential of benefiting a much larger segment of patients than current therapies with fewer side effects since its target is expressed in up to 80% of GEC tumors, but is not targetable in healthy cells,” said Dr. Özlem Türeci, chief executive officer of Ganymed.
“I would like to thank every patient who is participating in this study as well as congratulate all our investigators and clinical sites for completing recruitment on time. The Ganymed team did an excellent job,” added Prof. Rolf Krebs, chairman of the Supervisory Board.
The randomized three-arm Phase 2 FAST (First-line treatment of patients with CLDN18.2-positive advanced Adenocarcinomas of the STomach, the esophagus or the gastroesophageal junction) clinical trial aims to evaluate the efficacy and safety of IMAB362 in combination with the chemotherapy agents epirubicin, oxaliplatin, and capecitabine (EOX) in 210 patients with CLDN18.2-positive, advanced, unresectable, recurrent or metastatic GEC. CLDN18.2 expression in patients is being determined using Ganymed’s Claudetect 18.2 diagnostic test. The primary endpoints are progression-free survival and safety of IMAB362 in combination with EOX while median overall survival, time to progression, and objective tumor response rate are among the secondary endpoints.
Date: July 22, 2014
Source: Ganymed Pharmaceuticals
Filed Under: Drug Discovery
