Isofol Medical AB today announced that the the first patient in its randomized phase I/II trial, ISO-CC-002, has been enrolled. The study will evaluate pharmacokinetic and pharmacodynamic parameters of Isofol Medical’s lead candidate Modufolin® in patients with diagnosed with colon cancer.
”It is with great excitement that we announce that the first patient has been enrolled in ISO-CC-002. The study is an important part of our clinical development program for Modufolin®. We expect to receive information that will help us better understand and assess the characteristics of Modufolin® in both tumor tissue and blood plasma” 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 diagnosed 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.
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 two clinical phase I/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 Modufolin® ([6R] 5,10-methylenetetrahydrofolate) 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