Isofol Appoints The Sage Group to Identify Strategic Partnerships for its Novel Modufolin® Chemother

Isofol (www.isofolmedical.com), a clinical stage pharmaceutical company based in Gothenburg, Sweden, announces that following an internal review, it has launched a global program to identify one or more strategic partners for commercialization of its Modufolin® chemotherapy asset. The Sage Group (based in Europe, USA and Asia) has been appointed by Isofol to assist the company in this endeavor. The overall objective is to identify a well-established pharma partner who will work with the company to exploit the value of Modufolin® in what is believed to be a multi billion dollar market.

Jan-Eric Osterlund, Executive Chairman of Isofol, said “We are delighted to be working with The Sage Group, who are providing us with access to a global network of potential partners for our exciting Modufolin® asset. We are conducting two Phase 1/2 clinical trials with Modufolin® in colorectal cancer and in osteosarcoma and intend to work with a strategic partner on these and future trials. We expect this will lead to market approval worldwide and a much improved response rate for conventional chemotherapy. Identifying the correct partner(s) will be key to successful commercialization of this asset leading to improved patient outcomes because of its novel mode of action.”

Isofol believes that around 70% of patients are unable to achieve successful metabolic activation of leucovorin and levoleucovorin (today’s standard folate treatment in cancer) and thus fail to fully benefit from their chemotherapy treatment. As Modufolin® is the key active metabolite of leucovorin and levoleucovorin, it does not need to be activated in the body. Modufolin® thereby has the potential to enable these patients to more fully benefit from their chemotherapy treatments in the future, including 5-­fluorouracil (5-FU), one of the most prescribed chemotherapies today. Isofol’s ongoing clinical trials are focusing on colorectal cancer and osteosarcoma, but the potential reaches beyond that to other solid tumor cancers like pancreatic and gastric cancers.

Isofol Medical AB has recently announced publication of a study comparing the concentration of folate metabolites in tumor, mucosa, and plasma of patients with colon cancer after administration of Modufolin® or Isovorin® (levo-­ leucovorin). The results support Isofol’s belief that Modufolin® has the potential to increase the efficacy of 5-FU-­based chemotherapy for many patients. Results clearly demonstrated that Modufolin® administration resulted in significantly higher methylenetetrahydrofolate levels than Isovorin® administration. Isofol will continue to evaluate the potential of Modufolin® as a substitute to Isovorin® in the treatment of patients with colon cancer.

Scientists close to Isofol have recently published a study on samples from 200 patients indicating that patients treated with leucovorin having the gene expression needed to transform leucovorin and levoleucovorin into a high enough concentration of the active metabolite for improving the response rate of 5FU achieve considerably longer survival. This study has already been confirmed in a second prospective study. This indicates that if those patients with low gene expression were instead treated with Modufolin®, they may achieve the same longer survival time as those with high gene expression.

About Isofol

Isofol was founded in 2008 and is based on a co-operation between its founder Prof. Bengt Gustavsson MD, Ph.D., and Merck Millipore, the world's leading supplier of reduced folates. Isofol is a clinical stage pharmaceutical company developing novel products for unmet needs within oncology. Isofol’s lead clinical candidate, Modufolin®, is expected 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 continues to collaborate closely with its strategic R&D partner Merck Millipore.

In 2009, Isofol entered into the exclusive global collaboration agreement with Merck Millipore to develop the use of Modufolin® for a wide range of cancer treatments. Merck Millipore also holds the trademark and the intellectual property rights for the production process of Modufolin®. In 2013, Isofol announced the expansion of this agreement into a worldwide exclusive supply & license agreement with Merck KGaA and Merck & Cie (Merck) for the use of Modufolin® in cancer treatment.

To strengthen the development program of Modufolin®, Isofol formed a collaboration in 2014 with Recipharm to manufacture exclusively the finished product from the API.

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Modufolin® is a registered Trademark of Merck KGaA, Darmstadt, Germany.