First patient enrolled in Isofol Medical’s Phase I/II trial of Modufolin® in combination with 5‐FU and oxaliplatin in patients with stage IV colon cancer.

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.

About Modufolin®
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.

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