Isofol Medical receives approval to conduct its second clinical phase I/II study of Modufolin® in patients with colon cancer

Isofol Medical AB has received approval from the Swedish Medical Products Agency (Läkemedelsverket) to start a randomized phase I/II pharmacokinetic and pharmacodynamic study of its lead candidate Modufolin® in patients with colon cancer.

”The ISO-CC-002 clinical study is an important part of our clinical development program for Modufolin®. It will provide valuable data to help us assess the characteristics of Modufolin® in both blood plasma and tumor tissue” said Anders Rabbe, CEO of Isofol Medical.

The ISO-CC-002 trial is a single-blinded, randomized phase I/II study performed on 64 patients with colon cancer. It investigates the pharmacokinetic and pharmacodynamic properties of Modufolin® compared to levoleucovorin in tumor tissue, adjacent mucosa and blood plasma. The study is performed at the Sahlgrenska University Hospital in Göteborg, Sweden.

About Modufolin®
Modufolin® (6R-5,10-methylenetetrahydrofolate) is a novel folate-based drug developed to increase the efficacy and reduce the side effects of antimetabolites used in cancer treatment. Modufolin® is the key active metabolite of the widely used folate-based drug leucovorin. Modufolin® does not require enzymatic metabolic activation which may improve the therapeutic efficacy and safety of folate-based treatments. Modufolin® is currently being evaluated in combination with pemetrexed for the pre-operative treatment of rectal cancer in the clinical phase I/II study ISO-MC-091.

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 Modufolin® ([6R] 5,10-methylene tetrahydrofolate) is an endogenous folate-based biomodulator developed to increase the efficacy and decrease the side effects of chemotherapeutic agents used in the treatment of solid tumors. 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