Isofol announces that an abstract about Modufolin® in osteosarcoma treatment will be presented at ESMO 2017

Isofol Medical AB (publ) announces that an abstract about Modufolin® has been accepted to be presented at ESMO 2017, taking place 8-12th of September in Madrid. The accepted abstract describes the first clinical study results of Modufolin® as rescue therapy to be administrated after High Dose Methotrexate (HDMTX) treatment in osteosarcoma patients.

Isofol Medical AB (publ) announces that an abstract has been accepted for presentation at this year's meeting of the European Society for Medical Oncology (ESMO). The conference will take place on 8-12th of September in Madrid and is Europe's largest scientific congress in oncology.

The approved abstract describes the results from Isofol's first clinical study with Modufolin® as a rescue therapy in the treatment of osteosarcoma. The study is a dose-ranging and safety study in which patients from four different countries were treated with Modufolin® as rescue therapy administrated after HDMTX in accordance with the standardized treatment regimen MAP. The aim of the study was to map safety and to select the optimal dose for continued clinical development of Modufolin®.

The study is a significant milestone for Isofol, as it is the first study to generate clinical data with Modufolin® as a rescue therapy after HDMTX in the treatment of osteosarcoma patients. The study has been shepherded and organized by senior physician Professor Mikael Eriksson, from the oncology clinic at Skåne University Hospital in Lund.

Abstract

Title: Development of a new promising rescue agent for high dose methotrexate (HDMTX) treatment in osteosarcoma - a safety and dose finding study

Final publication number: 1520P

Authors: Mikael Eriksson, Department of Oncology, Skåne University Hospital, Lund Magdalena Rychłowska-Pruszyńska, The Institute of Mother and Child, Paediatric Surgical Oncology Clinic Warsaw Monika Csoka, Semmelweis University 2nd Department of Paediatrics, Budapest Edita Kabíčková, Motol University Hospital Department of Paediatric Haematology and Oncology, Prague.  Peter Mudry, Department of Pediatric Oncology, University Hospital Brno and School of Medicine, Masaryk University.

HDMTX is a common therapeutic regimen in the treatment of osteosarcoma with folate-based therapies used as the golden standard to prevent treatment related high-dose toxicity. Isofol’s lead candidate Modufolin® is currently being investigated as a novel and superior folate-based treatment for the same purpose.

Osteosarcoma

Osteosarcoma is a rare (accounting for 0.2% of all malignant tumours) primary malignant tumour of the skeleton that mainly affects children and young adults. The mean annual incidence of osteosarcoma was estimated between 1998 and 2000 to be around 2.9 (range 1.5-4.0) per 1,000,000 individuals within the EU.

For more information, please contact:

Anders Rabbe, CEO, Isofol Medical AB

E­mail: anders.rabbe@isofolmedical.com

Phone: +46 (0)707 646 500

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. As Modufolin® does not require metabolic activation to exert it’s effect, Modufolin® is suitable for all patients irrespective of their capacity to activate folates. Modufolin® 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. Isofol Medical AB is traded on the NASDAQ First North Premier. Certified Adviser is FNCA Sweden AB 

www.isofol.se

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