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​ISOFOL ANSÖKER OM VIKTIGT PATENT I USA

Pressmeddelanden   •   Feb 20, 2017 13:36 CET

Isofol Medical AB (publ) meddelar att en ny patentansökan lämnats in, den 14 februari, 2017, till det amerikanska patentverket (US Patent and Trademark Office). Ansökan har baserats på nya upptäckter kring den kliniska effekten av Modufolin® samt ytterligare forskningsresultat.

Isofol har genomfört en första jämförelse mellan Modufolin® och dagens folatbaserade standardbehandling, leukovorin (LV), i patienter med kolorektalcancer beträffande aktiviteten hos enzymet tymidylassyntas (TS) som mättes med hjälp av en universalt accepterad biomarkör. Administration av Modufolin ledde bland annat till en önskvärd signifikant högre grad hämning av TS jämfört med LV. Modufolin® uppvisade vidare en dosberoende ökning av hämningen, vilket innebar att hämningen av TS ökade vid högre doser av Modufolin®. Bättre hämning av TS är ett eftertraktat mål då det kan leda till en bättre effekt av dagens behandling hos patienter med kolorektalcancer. Resultaten stödjer utformningen av den planerade (registreringsgrundande) pivotalstudien, ISO-CC-007, med Modufolin® som avses starta mot slutet av året.

Anders Rabbe, VD på Isofol, kommenterar: ”Inom ramen för vårt samarbete med Professor Bengt Gustavsson, vid Sahlgrenska Universitetssjukhuset i Göteborg, har Isofol fortsatt att definiera viktiga aspekter kring en förbättrad behandling av kolorektalcancer samt gjort framstående upptäckter som nu ligger till grund för denna nya patentansökan. Isofol anser att patentet kommer att utgöra ett gott tillskott till vårt skydd för Modufolin® när patentet godkänts. Forskningsresultaten stärker dessutom upplägget av vår planerade pivotalstudie och det återstående arbetet inför ett marknadsgodkännande.”

Isofol Medical AB arbetar för att flera patienter med kolorektalcancer ska kunna tillgodogöra sig den standardbehandling med cellgiftet 5-FU (fluorouracil) och folater som ges idag. Isofols utvecklingskandidat, Modufolin behöver, till skillnad mot folaterna leukovorin och levolekovorin, inte omvandlas i flera steg i kroppen för att kunna utöva sin effekt. Modufolin utvecklas som ett förstahandsalternativ vid behandling av kolorektalcancer för att öka effektiviteten och minska biverkningar hos patienter som behandlas med 5-FU. Dagens forskningsresultat ger Isofol ytterligare bekräftelse av den kliniska verkningsmekanismen hos Modufolin® samt stödjer att Modufolin® har potential att åstadkomma högre grad av hämning av TS och som följd bättre behandlingssvar med 5-FU för alla patienter än vad dagens standardbehandling med leukovorin möjliggör.

Tredje vanligaste cancerformen
Kolorektalcancer är den tredje vanligaste cancerformen, som påverkar både män och kvinnor, och är den tredje vanligaste orsaken till cancerrelaterade dödsfall. Globalt beräknas ca 1,35 miljoner personer årligen drabbas av denna form av cancer. I USA, Västeuropa och Japan, där ca 550 000 patienter drabbas av Kolorektalcancer, får ca 365 000 patienter årligen behandling med 5FU och folaten leukovorin och levoleukovorin, vilket Isofol har som ambition att ersätta med Modufolin.

Om Modufolin®
Modufolin® ( [6R]-5,10-methylenetetrahydrofolate) är ett nytt folatbaserat läkemedel framtaget för att öka effekten och minska biverkningarna vid cancerbehandling med antimetaboliter. Modufolin® innehåller den direkt aktiva metaboliten för alla dagens folatbaserade läkemedel som används kliniskt, inklusive leukovorin och levoleukovorin. Till skillnad från dessa kräver inte Modufolin® metabol aktivering för att åstadkomma klinisk effekt hos en patient. Det gör behandlingen oberoende av patientens genetiskt reglerade förmåga att omvandla folater och Modufolin® utvärderas för nuvarande i två kliniska fas 2-studier.

Om Isofol Medical AB
Isofol Medical AB är ett onkologibolag som kliniskt utvecklar Modufolin® som ett förstahandsval vid behandling av kolorektalcancer och som standardterapi vid högdosbehandling med metotrexat av osteosarkom. Genom ett världsomfattande, exklusivt licensavtal innehar Isofol Medical kommersialiseringsrättigheterna till Modufolin® samt tillgång till Merck KGaAs (Darmstadt, Tyskland) patentskyddade tillverkningsprocess och produktionsförmåga. www.isofolmedical.se

För mer information, vänligen kontakta:
Anders Rabbe, Managing Director, Isofol Medical AB
E‐mail: anders.rabbe@isofolmedical.com
Telefon: +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 FÅR KLARTECKEN FRÅN FDA ATT PÅBÖRJA KLINISKT PROGRAM INOM KOLOREKTALCANCER MED MODUFOLIN®

Pressmeddelanden   •   Jan 24, 2017 08:30 CET

Isofol Medical AB meddelar att den amerikanska läkemedelsmyndigheten (FDA) har slutfört sin granskning av bolagets ansökan om kliniska studier i USA (Investigational New Drug, IND) och meddelat att den första föreslagna kliniska studien med Modufolin® under en IND kan påbörjas. Myndighetens utlåtande är baserat på en noggrann genomgång av Isofols utvecklingsplan inom kolorektalcancer där bland annat egenskaperna hos Modufolin® samt befintlig preklinisk- och klinisk data har granskats.

Isofol Medical AB arbetar för att fler patienter med spridd kolorektalcancer ska kunna tillgodogöra sig den standardbehandling som ges idag. Årligen behandlas globalt mer än en halv miljon patienter med två folatbaserade terapier, leukovorin och levoleukovorin, men Isofols forskning visar att endast en mindre del av dessa patienter svarar på denna behandling. Isofols utvecklingskandidat, Modufolin, innehåller den aktiva metaboliten i leukovorin och levolekovorin och behöver inte omvandlas för att utöva sin effekt. Modufolin utvecklas som ett förstahandsalternativ vid behandling av spridd kolorektalcancer för att öka effektiviteten och minska biverkningar hos patienter som behandlas med 5-FU (fluorouracil).

”Dagens nyhet är mycket glädjande och en stor milstolpe för Isofol. USA är en strategisk målmarknad och intervjuer med opinionsledare indikerar ett stort intresse kring de potentiella behandlingsfördelarna med Modufolin. Beskedet från FDA är därför ett avgörande steg för vår kommersiella plan och en viktig bekräftelse för våra aktieägare. Detta, tillsammans med våra tidigare myndighetsinteraktioner, tar oss ännu ett steg närmre ett marknadsgodkännande”, säger Anders Rabbe, VD på Isofol.

Beskedet från FDA gör det möjligt för Isofol att starta en klinisk fas 1-studie på friska frivilliga män för att utvärdera om administrering av Modufolin påverkar hjärtat med hänsyn till EKG (elektrokardiografi) förändringar, framförallt QTc-förlängning. Utöver detta kommer säkerhet, tolerabilitet och farmakokinetiska/farmakodynamiska profil i plasma att kartläggas för Modufolin samt dess metaboliter vid olika doser som injiceras. Studien, som planeras att starta inom kort, kommer att utföras vid Uppsala Akademiska Sjukhus och avser att omfatta 33 patienter. Senare under 2017 avser Isofol även inleda en studie med syfte att nå ett marknadsgodkännande av Modufolin.

”Behandlingsresultatet för patienter som idag behandlas med 5-FU och folatbaserade terapier är inte optimalt då endast en minoritet svarar på behandlingen. Isofol har i studier visat att patienters genuppsättning påverkar behandlingsutfallet. Vårt mål med Modufolin är att alla patienter ska ges samma förutsättningar, oavsett ärftliga faktorer. Dagens besked från FDA bekräftar att vi håller hög kvalitet på vår dokumentation och att Modufolin är säkert. Vi ser nu fram emot att inleda den kliniska studien”, tillade Karin Ganlöv, CMO på Isofol.

Isofol rapporterade i maj (2016) att diskussioner med regulatoriska myndigheter i USA och Europa hade resulterat i en tydlig utvecklingsplan med mål att registrera Modufolin. Förberedelsearbetet inför en registreringsstudie pågår och dagens besked angående Isofols IND-ansökan är därför en viktig milstolpe.

Tredje vanligaste cancerformen
Kolorektalcancer är den tredje vanligaste cancerformen, som påverkar både män och kvinnor, och är den tredje vanligaste orsaken till cancerrelaterade dödsfall. Globalt beräknas ca 1,35 miljoner personer årligen drabbas av denna form av cancer. I USA, Västeuropa och Japan, där ca 550 000 patienter drabbas av Kolorektalcancer, får ca 360 000 patienter årligen behandling med 5FU och folaten leukovorin och levoleukovorin, som Isofol har som ambition att ersätta med Modufolin.

Om Modufolin®
Modufolin® (aktiv ingredient: [6R]-5,10-methylenetetrahydrofolate) är ett nytt folatbaserat läkemedel framtaget för att öka effekten och minska biverkningarna vid cancerbehandling med antimetaboliter. Modufolin® innehåller den aktiva metaboliten hos alla dagens folatbaserade läkemedel som används kliniskt, inklusive leukovorin och levoleukovorin. Till skillnad från dessa kräver inte Modufolin® metabol aktivering för att åstadkomma en klinisk effekt hos en patient. Det gör behandlingen oberoende av patientens ärftliga förmåga att omvandla folater och utvärderas för nuvarande i två kliniska fas 2-studier. 

Om Isofol Medical AB
Isofol Medical AB är ett onkologibolag som kliniskt utvecklar Modufolin® som ett förstahandsval vid behandling av spridd kolorektalcancer och som standardterapi vid högdosbehandling med metotrexat av osteosarkom. Genom ett världsomfattande, exklusivt licensavtal innehar Isofol Medical kommersialiseringsrättigheterna till Modufolin® samt tillgång till Merck KGaAs (Darmstadt, Tyskland) patentskyddade tillverkningsprocess och produktionsförmåga. www.isofolmedical.se

För mer information, vänligen kontakta:
Anders Rabbe, Managing Director, Isofol Medical AB
E‐mail: anders.rabbe@isofolmedical.com
Telefon: +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.  


Isofol Medical AB meddelar att den amerikanska läkemedelsmyndigheten (FDA) har slutfört sin granskning av bolagets ansökan om kliniska studier i USA (Investigational New Drug, IND) och meddelat att den första föreslagna kliniska studien med Modufolin® under en IND kan påbörjas.

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

Pressmeddelanden   •   Jan 24, 2017 08:30 CET

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

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 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.

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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®

Pressmeddelanden   •   Maj 24, 2016 14:22 CEST

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 now initiate preparations for a pivotal Phase II/III clinical trial in colorectal cancer and has the possibility to complete the clinical development program with only one pivotal efficacy study in each of the two indications being focused on (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®

Pressmeddelanden   •   Mar 14, 2016 13:00 CET

March 14, 2016

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

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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Isofol successfully completes first dose cohort with Modufolin® as a rescue therapy in osteosarcoma patients after high dose methotrexate (HDMTX) treatment

Pressmeddelanden   •   Dec 10, 2015 14:07 CET

Isofol successfully completes first dose cohort with Modufolin® as a rescue therapy in osteosarcoma patients after high dose methotrexate (HDMTX) treatment

December 10, 2015

Isofol Medical AB today announced that the first dose cohort with Modufolin® as rescue therapy, after treatment with two cycles of HDMTX, fulfilled the study objectives in the ongoing Phase I/II open-label, multicenter clinical trial, ISO-MTX-003. In total four patients with osteosarcoma have successfully completed their treatment with Modufolin® at 15 mg/m2. Isofol is now initiating a second dose cohort where 3-6 patients will be treated with 7.5 mg/m2 of Modufolin®. This is a safety/efficacy study and is intended to identify the dose with most favorable safety that mitigates HDMTX induced toxicity.

“I am very pleased with the completion of this first dose cohort with Modufolin®. This study, to define a safe and efficacious dose of Modufolin® when administered as a rescue therapy with high dose methotrexate treatment in osteosarcoma patients, is an important part of our development strategy for Modufolin®. The resulting dose from this study will be used in Isofol’s pivotal study in osteosarcoma that we plan to initiate during the second half of 2016” 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.

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.

Study objectives fulfilled in first dose cohort with Modufolin® as rescue therapy after treatment with two cycles of HDMTX. Four patients with osteosarcoma successfully completed their treatment with Modufolin® at 15 mg/m2. Isofol is now initiating a second dose cohort where 3-6 patients will be treated with 7.5 mg/m2 of Modufolin®.

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Isofol successfully completes first dose cohort with Modufolin® as a rescue therapy in osteosarcoma patients after high dose methotrexate (HDMTX) treatment

Pressmeddelanden   •   Dec 10, 2015 14:01 CET

Isofol successfully completes first dose cohort with Modufolin® as a rescue therapy in osteosarcoma patients after high dose methotrexate (HDMTX) treatment

December 10, 2015

Isofol Medical AB today announced that the first dose cohort with Modufolin® as rescue therapy, after treatment with two cycles of HDMTX, fulfilled the study objectives in the ongoing Phase I/II open-label, multicenter clinical trial, ISO-MTX-003. In total four patients with osteosarcoma have successfully completed their treatment with Modufolin® at 15 mg/m2. Isofol is now initiating a second dose cohort where 3-6 patients will be treated with 7.5 mg/m2 of Modufolin®. This is a safety/efficacy study and is intended to identify the dose with most favorable safety that mitigates HDMTX induced toxicity.

“I am very pleased with the completion of this first dose cohort with Modufolin®. This study, to define a safe and efficacious dose of Modufolin® when administered as a rescue therapy with high dose methotrexate treatment in osteosarcoma patients, is an important part of our development strategy for Modufolin®. The resulting dose from this study will be used in Isofol’s pivotal study in osteosarcoma that we plan to initiate during the second half of 2016” 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.

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.  


Study objectives fulfilled in first dose cohort with Modufolin® as rescue therapy after treatment with two cycles of HDMTX. Four patients with osteosarcoma successfully completed their treatment with Modufolin® at 15 mg/m2. Isofol is now initiating a second dose cohort where 3-6 patients will be treated with 7.5 mg/m2 of Modufolin®.

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Isofol successfully completes first dose cohort with Modufolin® as a rescue therapy in osteosarcoma patients after high dose methotrexate (HDMTX) treatment

Pressmeddelanden   •   Dec 10, 2015 13:55 CET

Isofol successfully completes first dose cohort with Modufolin® as a rescue therapy in osteosarcoma patients after high dose methotrexate (HDMTX) treatment

December 10, 2015

Isofol Medical AB today announced that the first dose cohort with Modufolin® as rescue therapy, after treatment with two cycles of HDMTX, fulfilled the study objectives in the ongoing Phase I/II open-label, multicenter clinical trial, ISO-MTX-003. In total four patients with osteosarcoma have successfully completed their treatment with Modufolin® at 15 mg/m2. Isofol is now initiating a second dose cohort where 3-6 patients will be treated with 7.5 mg/m2 of Modufolin®. This is a safety/efficacy study and is intended to identify the dose with most favorable safety that mitigates HDMTX induced toxicity.

“I am very pleased with the completion of this first dose cohort with Modufolin®. This study, to define a safe and efficacious dose of Modufolin® when administered as a rescue therapy with high dose methotrexate treatment in osteosarcoma patients, is an important part of our development strategy for Modufolin®. The resulting dose from this study will be used in Isofol’s pivotal study in osteosarcoma that we plan to initiate during the second half of 2016” 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.

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.  


Study objectives fulfilled in first dose cohort with Modufolin® as rescue therapy after treatment with two cycles of HDMTX. Four patients with osteosarcoma successfully completed their treatment with Modufolin® at 15 mg/m2. Isofol is now initiating a second dose cohort where 3-6 patients will be treated with 7.5 mg/m2 of Modufolin®.

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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

Pressmeddelanden   •   Maj 28, 2015 09:22 CEST

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

Pressmeddelanden   •   Apr 14, 2015 09:00 CEST

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.

Läs vidare »

Kontaktpersoner 2 kontaktpersoner

  • Presskontakt
  • CEO
  • fnyxantvrqdeporsmg.rabbelw@iqqsoflfolmedxiicnfprzkal.com
  • +46 (0)707 646 500

  • Presskontakt
  • Executive Chairman
  • jan-eric@osterlund.co.uk
  • + 44 7785 368155

Om 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.

Adress

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