Isofol Medical

Isofol is a clinical stage pharmaceutical company developing novel products for unmet needs within oncology. Isofol’s lead clinical candidate, Modufolin®, is predicted to improve the outlook for cancer patients undergoing chemotherapy treatment with a range of antimetabolites. Isofol’s ongoing clinical trials are focusing on colorectal cancer and osteosarcoma. Isofol collaborates closely with its strategic R&D partner Merck Millipore, the world’s leading manufacturer of reduced folates.

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Modufolin® development

Modufolin® is a folate-based bio-modulator designed to replace leucovorin/levoleucovorin as the preferred treatment to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU (5-flluorouracil). It is currently being evaluated in three Phase I/II studies, two in colorectal cancer and one in osteosarcoma.
 
Although several modern chemo drugs have been introduced that dramatically improve the treatment of many cancer diseases, they show limited effect in treating solid tumors. 5-FU and leucovorin/levoleucovorin is still the core treatment used today for colorectal cancer and Modufolin® has the potential to enable 5-FU to work more effectively.

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Clinical trials

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News & Press information

Isofol Medical has successfully advanced to the next dose level of Modufolin® in a phase I/II clinical trial in colorectal cancer.
6/2/2016: Isofol Medical AB today announced initiation of the next dose level of Modufolin®, 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 Modufolin® at 30 mg/m2. Isofol has now initiated a second dose level of Modufolin®, 60mg/m2, in combination with 5-FU and oxaliplatin or 5-FU and irinotecan. This is a safety study evaluating four different doses of Modufolin® with the intention to identify the dose with most favourable tolerability.
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®
5/24/2016: 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.
Isofol Medical AB, Biotech Center, Arvid Wallgrens Backe 20, SE-413 46 Gothenburg, Sweden
Phone: +46 (0) 707 64 65 00 E-mail: info@isofolmedical.com