Anders Rabbe, chief executive officer of Isofol, said, “We look forward to bringing arfolitixorin to all patients in need of an improved therapy for metastatic colorectal cancer, a devastating disease with minor therapeutic advancements in the first line treatment over the past 15 years.”
Following completion of the Special Protocol Assessment (SPA) review by the U.S. Food and Drug Administration (FDA), Isofol has decided to move forward with the ISO-CC-007 study under the U.S. IND (Investigational New Drug) without delay and discontinue the SPA process. This decision will not have any substantial impact on the clinical or regulatory processes of the pivotal Phase 3 clinical trial of arfolitixorin.
The Phase 3 clinical trial protocol for the IND meets the FDA’s requirements for safety and primary as well as secondary efficacy endpoints, overall response rate (ORR) and progression-free survival (PFS).
The ISO-CC-007 study will be conducted in the U.S., Canada and Europe. The study protocol has been submitted and first approvals have already been granted. Patient recruitment in the ISO-CC-007 study is therefore expected to start in December 2018.
This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET on November 15, 2018.
Lianyungang Klinechem Co., Ltd
Contact Person: Dr. John Liu
Address: Jingqi Road, Weiwu Road, Coastal Industrial Park, Guanyun County, Lianyungang City, Jiangsu Province