Isofol Medical AB today announced that the first dose cohort with Modufolin® as rescue therapy, after treatment with two cycles of HDMTX, fulfilled the study objectives in the ongoing Phase I/II open-label, multicenter clinical trial, ISO-MTX-003. In total four patients with osteosarcoma have successfully completed their treatment with Modufolin® at 15 mg/m2. Isofol is now initiating a second dose cohort where 3-6 patients will be treated with 7.5 mg/m2 of Modufolin®. This is a safety/efficacy study and is intended to identify the dose with most favorable safety that mitigates HDMTX induced toxicity.
“I am very pleased with the completion of this first dose cohort with Modufolin®. This study, to define a safe and efficacious dose of Modufolin® when administered as a rescue therapy with high dose methotrexate treatment in osteosarcoma patients, is an important part of our development strategy for Modufolin®. The resulting dose from this study will be used in Isofol’s pivotal study in osteosarcoma that we plan to initiate during the second half of 2016” said Anders Rabbe, CEO of Isofol Medical.
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 being 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