ISOFOL FILES IMPORTANT NEW US PATENT APPLICATION

Isofol Medical AB (publ) today announces that a new patent application was filed, on February 14, 2017, to the US Patent and Trademark Office. As basis for the application Isofol has inserted new findings in relation to the clinical effect of Modufolin® as well as other research data.

Using a universally accepted biomarker for the activity of the enzyme thymidylate synthase (TS), Isofol has completed a first comparison of the effects of Isofol’s Modufolin® compared with today’s standard folate, leucovorin (LV) in patients with colorectal cancer. Modufolin®-administration, as an example, led to significantly higher inhibition of TS compared to LV. There was also a dose-dependent increase of the TS inhibition after Modufolin®, i.e. the higher the Modufolin® dose the higher the TS inhibition. Enhanced inhibition of TS is a desired effect in order to improve today’s treatment of colorectal cancer patients. The findings strongly support the planned design of the Modufolin® pivotal study, ISO-CC-007, predicted to start towards the end of this year,

Anders Rabbe, Managing Director of Isofol, says: ”Within our ongoing collaboration with Professor Bengt Gustavsson, Sahlgrenska Academy, Gothenburg, Isofol has continued to define important aspects of improved treatment of colorectal cancer and made significant discoveries now forming a partial basis for this new patent application. Isofol believes that this patent, when granted, will be an important contribution to our overall protection of the Modufolin® asset. In addition, the results strongly endorse our plans for the pivotal study and remaining work to compile an NDA”.

Isofol Medical aims at increasing the number of patients that respond to the standard of care within colorectal cancer. Isofol’s clinical lead candidate, Modufolin®, contains the key active metabolite of all clinically used folate-based drugs, including leucovorin and levoleucovorin, and therefore does not require metabolic activation to exert its action. Modufolin® is developed for treatment of colorectal cancer, to increase the efficacy and reduce the side effects for patients receiving 5-FU (fluorouracil). Today’s new scientific findings, , provide further clinical confirmation of the key action of Modufolin® and supports the hypothesis that Modufolin® has the potential to achieve higher inhibition of TS and therefore, better response to treatment with 5-FU than the current universal standard, leucovorin.

Third most common cancer
Colorectal cancer is the third most common cancer, affecting both men and women, and is the third-leading cause of cancer-related death. Approximately 1.35 million people per year are diagnosed with the disease worldwide. In the US, Western Europe and Japan, where an estimated 550 000 patients are diagnosed with colorectal cancer, about 365 000 patients annually receive – 5-FU and leucovorin/levoleucovorin – the same regimen that Isofol is aiming at improving by replacing leucovorin/levoleucovorin with Modufolin®.

About Modufolin®
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, 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 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. www.isofolmedical.se

For more information, please contact:
Anders Rabbe, Managing Director, Isofol Medical AB
E‐mail: anders.rabbe@isofolmedical.com
Phone: +46 (0)707 646 500