FDA CLEARS ISOFOL’S IND APPLICATION TO START CLINICAL PROGRAM WITHIN COLORECTAL CANCER WITH MODUFOLIN®
Isofol Medical AB announces that the US Food and Drug Administration (FDA) has cleared Isofol’s investigational new drug (IND) application and that the company has received a notice that the proposed clinical study with Modufolin® may proceed. FDA’s conclusion is based on its review of Isofol’s submitted documentation covering pharmaceutical quality/CMC, preclinical and clinical data related to the development of Modufolin® in colorectal cancer.Isofol Medical aims to increase the number of patients that respond to the standard of care within metastasized colorectal cancer. Today, more than