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Isofol Announces Successful Meetings With European and US Regulatory Authorities Regarding the Design of a Pivotal Phase II Clinical Trial of Isofol's Lead Drug Candidate, Modufolin®
Gothenburg, Sweden (ots/PRNewswire) - Isofol Medical AB, a clinical stage pharmaceutical company, developing novel products for unmet needs within oncology is pleased with the outcome of these meetings and will initiate preparations for a pivotal Phase II/III clinical trial in colorectal cancer. This presents the possibility of completing the clinical development program with only one pivotal efficacy study in each of the two indications being focused on by Isofol (colorectal cancer and osteosarcoma), thereby shortening the time to registration by several years, in comparison to the usual industry standard.
"We are very pleased with the outcome of these meetings, and we will now continue the preparations to initiate this study during the first half of 2017. The study is seen as pivotal, meaning that it may form the basis for a regulatory approval, assuming certain endpoints are met" said Anders Rabbe, CEO of Isofol Medical.
Modufolin® is currently being evaluated in Phase I/II studies, in colorectal cancer (CRC) with 5-FU and Oxaliplatin and in Osteosarcoma with HDMTX.
With limited clinical risks, Modufolin® has the potential to replace the folate drugs used today as Modufolin® could be beneficial for all patients irrespective of their capacity to activate folates. A majority of all patients treated for colorectal cancer with chemotherapy are also treated with folates, making the combination the most commonly used cancer treatment in the world. The market opportunity for Modufolin® is measured in billions of US$.
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.
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®, a novel folate-based compound. Isofol Medical collaborates closely with its strategic R&D partner Merck Millipore, the world's leading manufacturer of reduced folates including leucovorin and levoleucovorin.
Modufolin® is a registered Trademark of Merck KGaA, Darmstadt, Germany.
, please contact:
Anders Rabbe, CEO, Isofol Medical AB