amcure Presents Phase I/Ib Study Design For Lead Compound AMC303 At ESMO 2017 Congress
Published: Sep 11, 2017
EGGENSTEIN-LEOPOLDSHAFEN, Germany--(BUSINESS WIRE)--amcure, a biopharmaceutical company developing first-in-class cancer therapeutics, today presented the clinical study design of the ongoing Phase I/Ib clinical trial of its lead development candidate, AMC303, at the European Society for Medical Oncology (ESMO) 2017 Congress held in Madrid, Spain from September 8-12, 2017. The poster, which was presented in the “Trials in Progress” session of the Congress, highlighted important aspects of the clinical study design and primary as well as secondary objectives of the trial. AMC303, a therapeutic peptide inhibiting CD44v6, is currently being tested as a monotherapy in patients with advanced solid tumors of epithelial origins.
“The design of the Phase I/Ib clinical trial for AMC303 has been carefully crafted for us to determine safety and early signs of antitumor efficacy of our new compound in cancer patients with advanced and metastatic solid tumors,” said Klaus Dembowsky, CEO of amcure. “With its distinct mechanisms of action blocking multiple relevant oncological pathways, AMC303 could be a valuable new therapeutic modality for epithelial cancer patients who have limited treatment options and we are looking forward to the results from the first-in-human study.”
The poster illustrates the design and objectives of the first-in-human Phase I/Ib clinical trial that was initiated by amcure in October 2016. The background of AMC303 with preclinical safety and efficacy data is also provided in the poster. The primary objective of the two part, open label, non-randomized, multi-center, dose escalation study is to determine safety and tolerability of AMC303 and to establish the maximum dose and recommended Phase II dose. A secondary objective of the trial will be to evaluate early signs of antitumor efficacy of AMC303 supported by analysis of a comprehensive set of biomarkers to identify pharmacologic responses to the treatment. The study includes patients with advanced metastatic solid tumors of epithelial origin, who did not respond to conventional therapy and for whom no standard treatment is currently available.
The full presentation titled, “First-in-Human Study of AMC303 as Monotherapy in Patients with Advanced and Solid Tumors of Epithelial Origin” presented at the ESMO Conference 2017 is available on the Company’s website under “Posters & Publications” or by accessing the following link: https://amcure.com/posters-publications-new
Further detailed information about the trial can be found at http://bit.ly/2xGEMxb.
amcure’s lead compound, AMC303, is being developed as a potential treatment for patients with advanced and metastatic epithelial tumors, e.g. pancreatic cancer, head and neck cancer, gastric cancer, colorectal cancer, breast cancer and lung cancer. AMC303 has a high specificity for inhibiting CD44v6, a co-receptor required for signaling through multiple cellular pathways (c-Met, VEGFR-2, RON) involved in tumor growth, angiogenesis and the development and regression of metastases. AMC303 has demonstrated strong effects in various in vitro and in vivo assays.
amcure GmbH is a spin-off from the Karlsruhe Institute of Technology established in 2012. The company develops peptide-based compounds for the treatment of highly metastatic forms of cancer. amcure’s most advanced development candidate, AMC303, has entered clinical development and has demonstrated in in vivo animal proof-of-concept studies a high efficacy against different types of epithelial cancers. amcure is supported by a grant from the German Federal Ministry of Education and Research.
Dr. Klaus Dembowsky
Phone: +49 (0) 7247 934249-4 or +49 (0) 171 7930077
Fax: +49 (0) 7247 934249-9
MacDougall Biomedical Communications
Gretchen Schweitzer or Mario Brkulj
Phone: +49 (0) 89 2423 3494 or +49 (0) 175 5010575