Isofol Medical has announced that the first patient has been enrolled in a Phase I/II, single centre, open label study to identify the safety and tolerability of a dose of Modufolin in combination with the routine doses of 5–FU and oxaliplatin. The study will be carried out in patients with stage IV colon cancer and the results will be used to define the dose to be further documented in a blinded multicentre efficacy trial.
“I am very pleased that the first patient has been enrolled in this study as it is important in our ongoing clinical development program for Modufolin®. It is planned to help us define the efficacious dose of Modufolin® when administered with routine doses of 5-‐FU and oxaliplatin” said Anders Rabbe, CEO of Isofol Medical.
Chemotherapy is often given as a combination of drugs and the treatment regimen that includes a reduced folate with 5-‐FU and oxaliplatin is often referred to as FOLFOX.
The ISO-‐CC-‐005 trial is being initiated at Östra Hospital, Gothenburg, Sweden and will be performed on patients diagnosed with stage IV colon cancer.
Source: Isofol Medical pressrelease