Isofol Medical Has Successfully Advanced to the Next Dose Level of ModufolinŽ in a Phase I/II Clinical Trial in Colorectal Cancer

Thursday, June 2, 2016 Clinical Trials News J E 4

GOTHENBURG, Sweden, June 2, 2016 /PRNewswire/ --

Isofol Medical AB today announced initiation of the next dose level of ModufolinŽ, in combination with 5-FU and oxaliplatin or 5-FU and irinotecan, in the ongoing, incremental dose cohort, phase I/II clinical trial, ISO-CC-005. In total 16 patients with stage IV colorectal cancer have successfully completed their treatment with ModufolinŽ at 30 mg/m2. Isofol has now initiated a second dose level of ModufolinŽ, 60mg/m2, in combination with 5-FU and oxaliplatin or 5-FU and irinotecan. This is a safety study evaluating four different doses of ModufolinŽ with the intention to identify the dose with most favourable tolerability.  

The ISO-CC-005 trial also measures tumour response after 8 weeks of treatment. 12 patients have so far been evaluated after 8 weeks and according to the RECIST criteria all 12 patients have responded positively to the treatment.

"The results from our clinical trials with Modufolin to date are encouraging, in line with our expectations and fully support our continued development plans for colorectal cancer," said Anders Rabbe, CEO of Isofol Medical.

ModufolinŽ is currently being evaluated in Phase I/II studies, in colorectal cancer (CRC) with 5-FU and Oxaliplatin and in Osteosarcoma with HDMTX.

ModufolinŽ has the potential to replace the folate drugs used today as ModufolinŽ 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 and the combination is the must commonly used cancer treatment in the world. The market opportunity for ModufolinŽ is measured in billions of US$.

About ModufolinŽ 

ModufolinŽ (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 ModufolinŽ, 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.

ModufolinŽ is a registered Trademark of Merck KGaA, Darmstadt, Germany.


For more information, please contact: Anders Rabbe, CEO, Isofol Medical AB E-mail: Phone: +46(0)707-646-500


SOURCE Isofol Medical AB



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