Isofol Medical AB today 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 range of Modufolin in combination with the routine doses of 5-‐FU and oxaliplatin. Thestudy, ISO-‐CC-‐ 005 (NCT02244632), 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.
Modufolin®(chemical name [6R]-5,10-methylenetetrahydrofolate), is a novel folate-‐based compound developed to increase the efficacy and reduce the side effects of antimetabolites used in cancer treatment. It is the key active metabolite of all clinically used folate‐based drugs today including Leucovorin and Levoleucovorin and therefore does not require metabolic activation. This makes Modufolin® suitable for all patients irrespective of their capacity to activate folates and it is currently evaluated in clinical phase II studies.
About Isofol Medical AB
Isofol Medical is a clinical stage pharmaceutical company developing novel products for unmet needs within oncology. Isofol’s lead clinical candidate is Modufolin®. Isofol Medical collaborates closely with its strategic R&D partner Merck Millipore, the world’s leading manufacturer of reduced folates including Leucovorin and Levoleucovorin.
For more information, please contact:
Anders Rabbe, CEO, Isofol Medical AB
Phone: +46 (0)707 646 500
Modufolin® is a registered Trademark of Merck KGaA, Darmstadt, Germany.