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ISOFOL FILES IMPORTANT NEW US PATENT APPLICATION

Press Releases   •   Feb 20, 2017 12:38 GMT

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

Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.

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Isofol Medical has successfully advanced to the next dose level of Modufolin® in a phase I/II clinical trial in colorectal cancer.

Press Releases   •   Jun 02, 2016 12:03 GMT

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.

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.”

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

Modufolin® has the potential to replace the folate drugs used today as Modufolin® 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 Modufolin® is measured in billions of US$.

About Modufolin®

Modufolin® (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 Modufolin®, 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.

www.isofolmedical.se

For more information, please contact:

Anders Rabbe, CEO, Isofol Medical AB

E­mail: anders.rabbe@isofolmedical.com

Phone: +46 (0)707 646 500

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

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 Modufolin®, 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.

Isofol initiate 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, for colorectal cancer. This is a safety study evaluating four different doses of Modufolin® with the intention to identify the dose with most favourable tolerability.

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Isofol Medical has successfully advanced to the next dose level of Modufolin® in a phase I/II clinical trial in colorectal cancer.

Press Releases   •   Jun 02, 2016 12:03 GMT

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.

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.”

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

Modufolin® has the potential to replace the folate drugs used today as Modufolin® 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 Modufolin® is measured in billions of US$.

About Modufolin®

Modufolin® (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 Modufolin®, 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.

www.isofolmedical.se

For more information, please contact:

Anders Rabbe, CEO, Isofol Medical AB

E­mail: anders.rabbe@isofolmedical.com

Phone: +46 (0)707 646 500

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

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 Modufolin®, 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.

  


Isofol initiate 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, for colorectal cancer. This is a safety study evaluating four different doses of Modufolin® with the intention to identify the dose with most favourable tolerability.

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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®

Press Releases   •   May 24, 2016 12:28 GMT

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.

“We are very pleased with the outcome of these meetings, and we will now continue the preparations to initiate this study during the first half of 2017. The study is seen as pivotal, meaning that it may form the basis for a regulatory approval, assuming certain endpoints are met” said Anders Rabbe, CEO of Isofol Medical.

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

With limited clinical risks, Modufolin® has the potential to replace the folate drugs used today as Modufolin® 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, making the combination the most commonly used cancer treatment in the world. The market opportunity for Modufolin® is measured in billions of US$.

About Modufolin®

Modufolin® (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 Modufolin®, 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.

www.isofolmedical.se

For more information, please contact:

Anders Rabbe, CEO, Isofol Medical AB

E­mail: anders.rabbe@isofolmedical.com

Phone: +46 (0)707 646 500

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

Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.

Isofol Medical AB, will initiate preparations for a pivotal Phase II/III clinical trial in colorectal cancer and, with this trial, has the possibility to complete 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).

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Isofol Medical share issue oversubscribed, securing over SEK 39 million to strengthen the ongoing Phase II clinical development program of Modufolin®

Press Releases   •   Mar 14, 2016 12:48 GMT

Isofol Medical AB, a clinical stage pharmaceutical company, developing novel products for unmet needs within oncology, will use the investment to support the clinical program with Modufolin®, Isofol’s lead drug candidate. Modufolin® is a novel folate-based compound being developed to increase the efficacy and reduce the side effects of chemotherapeutic agents used in the treatment of solid tumors.

A large number of patients receiving reduced folate treatments as part of their chemotherapy regimens today do not fully benefit from their treatments as the benefit is dependent on a person’s ability to metabolize and thereby activate the reduced folate. With limited clinical risks Modufolin® has the potential to replace all reduced folate drugs used today, benefiting all patients irrespective of their capacity to metabolize and therefore activate reduced folates. The reason for this positive effect is that Modufolin® is the key active metabolite of all clinically used folate-based drugs used for cancer treatment today, and therefore does not require metabolic activation.

Reduced folates are part of the core chemotherapy treatment for both colorectal cancer and osteosarcoma, which are the first indications being targeted by Isofol.

“Raising this capital will enable us to continue our important clinical program and demonstrate the real value of Modufolin® for cancer patients. We are including more sites and increasing the enrolment rate of patients in our ongoing Phase I/II trials in both Osteosarcoma and Colorectal Cancer.” said Anders Rabbe, Managing Director of Isofol.

Even though several modern chemotherapy drugs have been introduced and provide dramatic effects in the treatment of certain cancers, they have had limited effect on solid tumors.

Modufolin® is currently being evaluated in clinical Phase I/II studies.

About Modufolin®

Modufolin® (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.

With limited clinical risks Modufolin® has the potential to replace the folate drugs used today as Modufolin® will be beneficial for all patients irrespective of their capacity to activate folates. Modufolin® is currently being evaluated in clinical Phase I/II studies.

www.isofolmedical.se

For more information, please contact:

Anders Rabbe, CEO, Isofol Medical AB

E­mail: anders.rabbe@isofolmedical.com

Phone: +46 (0)707 646 500

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

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 Modufolin®, 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.

Isofol Medical, a clinical stage pharmaceutical company, developing novel products for unmet needs within oncology, will use the investment to support the clinical program with Modufolin®, Isofol’s lead drug candidate. Modufolin® is a novel folate-based compound being developed to increase the efficacy and reduce the side effects of chemotherapeutic agents used in the treatment of solid tumors.

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Patent covering the use and pharmaceutical composition of Isofol’s lead Drug candidate, Modufolin®, allowed by United States Patent and Trademark Office

Press Releases   •   May 28, 2015 07:21 GMT

Isofol Medical AB today announced that the United States Patent and Trademark Office has allowed Isofol’s patentNo. 12/805,287, covering the use and pharmaceutical composition of [6R]-methylene-tetrahydrofolate (Modufolin®), to reduce toxicity resulting from multi-targeting antifolate chemotherapy.

Isofol provided evidence demonstrating the clear superiority of Modufolin® over folic acid in reducing pemetrexed toxicity.

“I am very pleased that the superiority of Modufolin® has been accepted by the United States Patent and Trademark Office and that this patent has been allowed. It will provide Modufolin® with long-term market exclusivity in this application” said Anders Rabbe, CEO of Isofol Medical.

Modufolin® is currently being evaluated in two Phase I/II studies, in colorectal cancer and in osteosarcoma.

About Modufolin®

Modufolin® (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. This makes Modufolin® suitable for all patients irrespective of their capacity to activate folates and it is currently being evaluated in clinical Phase 1/II studies.

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 Modufolin®. Isofol Medical collaborates closely with its strategic R&D partner Merck Millipore, the world’s leading manufacturer of reduced folates including leucovorin and levoleucovorin.

For more information please visit www.isofolmedical.se

For more information, please contact:

Anders Rabbe, CEO, Isofol Medical AB

E­mail: anders.rabbe@isofolmedical.com Phone: +46 (0)707 646 500

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

Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.

Isofol patent covering the use and pharmaceutical composition of Modufolin® allowed by the United States Patent and Trademark Office. Isofol provided evidence demonstrating the clear superiority of Modufolin® over folic acid in reducing toxicity resulting from multi-targeting antifolate chemotherapy.

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First patient successfully treated with Modufolin® as a rescue therapy with high dose methotrexate (HDMTX) treatment in Osteosarcoma.

Press Releases   •   Apr 14, 2015 07:00 GMT

Isofol Medical AB today announced that the first patient treated with Modufolin®, as rescue therapy, after treatment with two cycles of HDMX successfully fulfilled the study objectives. The patient is participating in a Phase I/II open-label, multicenter clinical trial where each patient is evaluated during two treatment cycles with HDMTX and Modufolin®. This is a safety/efficacy study in 3-6 patients and is intended to identify the dose with most favorable safety that mitigates HDMTX induced toxicity.

This is the first study in which HDMTX rescue therapy with Modufolin® is investigated, and Isofol predicts that Modufolin® will give more reproducible, reliable and thus robust rescue treatment with HDMTX than leucovorin or levoleucovorin, this hypothesis is firmly underpinned by science. Previous clinical results have shown no Modufolin® related side effects observed at dose levels between 10-500 mg/m2 after more than 240 administrations

“I am very pleased that the first patient now has been treated with Modufolin® in this study and that the study objectives were fulfilled successfully. This study is an important part of our development strategy for Modufolin® and is planned to help us define the safe and efficacious dose of Modufolin® when administered as a rescue therapy with high dose methotrexate treatment in osteosarcoma patients” said Anders Rabbe, CEO of Isofol Medical.

About Modufolin®

Modufolin®(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. This makes Modufolin® suitable for all patients irrespective of their capacity to activate folates and it is currently being evaluated in clinical phase II studies.

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 Modufolin®. Isofol Medical collaborates closely with its strategic R&D partner Merck Millipore, the world’s leading manufacturer of reduced folates including leucovorin and levoleucovorin.

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

Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.

The first patient treated with Modufolin®, as rescue therapy, after treatment with two cycles of HDMX successfully fulfilled the study objectives. This is a Phase I/II open-label, multicenter clinical trial intended to identify the dose with most favorable safety that mitigates HDMTX induced toxicity.

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Isofol presents at the Stockholm Corporate Finance Life Science Day

News   •   Mar 05, 2015 17:10 GMT

Isofol’s Chief Scientific Officer, Anders Vedin presented at the Stockholm Corporate Finance Life Science Day 2015 at Operaterrassen in Stockholm.

To see the presentation click here.


For more information, please contact:

Anders Rabbe, CEO,

E‐mail: anders.rabbe@isofolmedical.com

Phone: +46 (0)707 646 500

Anders Vedin

Chief Scientific Officer

Email: anders.vedin@isofolmedical.com

Phone: +46 (0)708 761 570

On March 4 2015 Isofol’s Chief Scientific Officer, Anders Vedin presented at the Stockholm Corporate Finance Life Science Day 2015 at Operaterrassen in Stockholm.

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Stockholm Corporate Finance Life Science Day 2015

News   •   Feb 25, 2015 14:58 GMT

February 25, 2015
Isofol’s Chief Scientific Officer, Anders Vedin will present the company at the Stockholm Corporate Finance Life Science Day 2015 at 13:45 on March 4, at Operaterrassen in Stockholm.

For more information, please contact:

Anders Rabbe, CEO, Isofol Medical AB

Email: anders.rabbe@isofolmedical.com

Phone: +46 (0)707 646 500

February 25, 2015 Isofol’s Chief Scientific Officer, Anders Vedin will present the company at the Stockholm Corporate Finance Life Science Day 2015 at 13:45 on March 4, at Operaterrassen in Stockholm.

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Isofol Appoints the Sage Group to Identify Strategic Partnerships for its Novel Modufolin® Chemotherapy Asset

Press Releases   •   Feb 04, 2015 10:45 GMT

February 4, 2015

Gothenburg, Sweden, Cambridge UK, and Clinton NJ – February 2015 – 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.

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

About The Sage Group, Inc.

The Sage Group Inc. is a leader in the provision of strategic and transactional advice to health care companies in the medical device, pharmaceutical, diagnostics, medical device, biotechnology and life science fields. Sage currently maintains offices in USA, Europe, Asia, Israel and Japan. Since its founding in 1994, The Sage Group has served more than 200 clients in the US, Europe and Asia, and completed numerous transactions including divestitures, alliances, acquisitions and financings with values up to $500 million.

The Sage Group is an organization of experienced and successful executives who are committed to the service of the very vital and dynamic health care industry and its investors.

Contact Details

Sage Europe:
Dr. W. T. Mason
Director, Sage Healthcare
Email: wtm@sagehealthcare.com
Tel: +44 (0)1638 508779

Sage USA:
Wayne Pambianchi
Director, Sage Healthcare
Email: wpambianchi@sagehealthcare.com
Tel: +1 908 2306170

Isofol Sweden:

Anders Rabbe

Managing Director

Email: anders.rabbe@isofolmedical.com

Tel +46 (0) 707 64 65 00

About Isofol Medical

Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.

Gothenburg, Sweden, Cambridge UK, and Clinton NJ – February 2015 – Isofol Medical announces that after 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 to assist the company in this endeavor.

Read more »

About Isofol Medical AB

Developing the next generation folate-based pharmaceuticals

Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.

Isofol Medical is based on 30 years of medical research which has resulted in the novel folate-based pharmaceutical product Modufolin®. Modufolin® is anticipated to increase the efficacy and reduce the side effects of cytotoxic pharmaceuticals. Isofol works closely with its strategic Swiss R&D partner Merck & Cie, the world’s leading manufacturer of reduced folates. In parallel to the drug development, Isofol Medical is performing diagnostic research to personalize and optimize the use of folate-based therapies for cancer treatment.

Isofol was founded in 2008 and is based on a co-operation between its founder Prof. Bengt Gustavsson MD, Ph.D., and Merck Millipore previously Merck Eprova, 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 with Recipharm to exclusively manufacture Modufolin® in 2014.

At the same time in 2014 Recipharm Venture Fund invested SEK 8 million in Isofol. Recipharm venture is a life science sector investor with a strategic interest in pharmaceutical and biotechnology companies in need of pharmaceutical development and manufacturing support.

Isofol intends to take Modufolin® to proof of efficacy in man through the current program of clinical trials. Isofol will then seek an arrangement for Modufolin® with a single partner who would undertake to, gain regulatory approval and ultimately market and sell Modufolin® on a worldwide basis.

Today Isofol holds pending patent protection for Modufolin® across all major markets.

Address

  • Isofol Medical AB
  • Biotech Center, Arvid Wallgrens Backe 20
  • 413 46 Göteborg
  • Sweden