FDA CLEARS ISOFOL’S IND APPLICATION TO START CLINICAL PROGRAM WITHIN COLORECTAL CANCER WITH MODUFOLIN®

Isofol Medical AB announces that the US Food and Drug Administration (FDA) has cleared Isofol’s investigational new drug (IND) application and that the company has received a notice that the proposed clinical study with Modufolin® may proceed. FDA’s conclusion is based on its review of Isofol’s submitted documentation covering pharmaceutical quality/CMC, preclinical and clinical data related to the development of Modufolin® in colorectal cancer.

Isofol Medical aims to increase the number of patients that respond to the standard of care within metastasized colorectal cancer. Today, more than 500 000 patients are treated each year with two folate-based therapies, leucovorin and levoleucovorin, but Isofol’s research shows that only a minority of these respond to their treatments. 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 as a first-line treatment of metastatic colorectal cancer, to increase the efficacy and reduce the side effects, for patients receiving 5-FU (fluorouracil).

”The FDA clearance is very encouraging and constitutes a major milestone for Isofol. We consider the US to be an important market and our interviews with US key opinion leaders indicate a huge interest in the possible advantages of Modufolin®. Today’s announcement is therefore an important step in our commercial plan and an external confirmation for our shareholders. This, together with our previous meetings with the regulatory authorities, advances our position towards a market approval”, said Anders Rabbe, Managing Director, Isofol.

FDA’s announcement enables Isofol to start a clinical phase 1 study, in healthy male volunteers, to investigate potential electrocardiogram (ECG) changes (i.e. QTc prolongation) associated with Modufolin® administration. In addition, safety, tolerability and the pharmacokinetic (PK)/pharmacodynamic (PD) profile of Modufolin® and its metabolites in plasma after bolus injections with different doses will be characterised. The study, that will soon be initiated, is to be conducted at the Uppsala Academic Hospital and is anticipated to enrol 33 patients. Later this year, Isofol will also initiate a study with the purpose to achieve a market approval for Modufolin®.

”Only a minority of patients treated with 5-FU and folate-based therapies achieve an optimal response. Isofol’s studies show that patient genetics affect treatment outcome. Our goal with Modufolin® is to offer the same conditions for all patients, regardless of their genetic makeups. Today’s announcement confirms the high quality of our documentation and the safety profile of Modufolin®. We are looking forward to initiate the clinical study”, added Karin Ganlöv, CMO, Isofol.

In May (2016), Isofol announced that meetings with regulatory authorities in the US and Europe had successfully resulted in a development plan for the market approval of Modufolin®. Preparatory work for the registration trial is ongoing and receiving IND clearance from the FDA is an important milestone.

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 expected to be affected by the disease, worldwide. In the US, Western Europe and Japan, where an estimated 550 000 patients are affected by colorectal cancer, about 360 000 patients annually receive - 5-FU and leucovorin/levoleucovorin - the same regimen that Isofol is aiming to replace.

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