Isofol Medical AB (publ) announced today that the last one of five additional study sites was initiated in Greece and is now ready to start inclusion in the ISO-CC-005 study. The study sites were initiated in order to ensure the planned recruitment rate in the study and to offer additional investigators opportunity to familiarize themselves with the Modufolin® treatment prior the upcoming pivotal study, ISO-CC-007, scheduled to start late 2017.
ISO-CC-005 is a Phase I/II open-label, multicenter clinical trial designed to identify the Modufolin® dose to be used in continued clinical development. The study is evaluating four different doses of Modufolin® in combination with 5-FU and oxaliplatin and/or irinotecan in patients with stage IV colorectal cancer. The dose selection is determined by how well the different doses are tolerated in addition to the side effect profile.The last one of five additional study sites has now been successfully initiated in Greece and is now ready to start inclusion in the ISO-CC-005 study. As part of Isofols clinical plan, the sites were initiated to ensure the planned recruitment rate in the study and to offer more investigators an opportunity to familiarize themselves with the Modufolin® treatment.
“I am very happy for the positive response we have received from investigators in Greece and of the successful initiation of the five additional study sites in the ISO-CC-005 study. The excitement from these study sites and clinical investigators to familiarize themselves with Modufolin® speaks in favor of the upcoming pivotal study ISO-CC-007 which we intensively prepare the initiation of at the moment”, says Anders Rabbe, CEO of Isofol Medical.
For more information, please contact:
Anders Rabbe, CEO, Isofol Medical AB
Phone: +46 (0)707 646 500
Modufolin® (active ingredient [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 the widely used folate-based drugs leucovorin and levoleucovorin. As Modufolin® does not require metabolic activation to exert it’s effect, Modufolin® is suitable for all patients irrespective of their capacity to activate folates. Modufolin® is currently being evaluated in two clinical Phase II studies.
About Isofol Medical AB
Isofol Medical AB is a clinical stage oncology company developing Modufolin® as a first-line treatment of metastatic colorectal cancer and as a rescue drug after high-dose methotrexate treatment in osteosarcoma. Through a worldwide exclusive license agreement, Isofol Medical holds the rights to commercialise Modufolin® with access to the unique patented production process and the production capabilities of Merck KGaA, Darmstadt, Germany. Isofol Medical AB is traded on the NASDAQ First North Premier. Certified Adviser is FNCA Sweden AB.