2cureX reports positive results from an ongoing clinical trial in heavily pre-treated colorectal cancer patients
February 20, 2019
Press Releases Regulatory
2cureX AB (“2cureX”) announces today that its first clinical trial where IndiTreat® is guiding treatment has met both the primary and the secondary end-points after an interim analysis. Of eight patients treated in accordance with IndiTreat® test results, five patients experienced Progression Free Survival (PFS) eight weeks after start of treatment.
Patients enrolled in the IndiTreat® colorectal cancer (CRC) clinical trial (ClinicalTrials.gov Identifier: NCT03251612) suffered from metastatic colorectal cancer and had been treated with at least two lines of standard treatments. Due to resistance towards standard treatments, 2cureX and University Hospital Vejle decided to include off-label drugs meaning drugs that are approved for other cancer entities and therefore not a part of CRC standard treatment guidelines.
2cureX announced in June 2018 that the trial had met a technical secondary end-point showing a 71% success rate regarding preparation of 3D micro-tumors from needle biopsies of liver metastases. Now 2cureX can add that planned interim analysis has shown that the trial also has met the efficacy end-point for continuation. To progress the trial at least five patients in the first cohort of the patients treated according to the IndiTreat® test had to have PFS at their first evaluation. Presently, 60% of the treated patients had PFS at their examination eight weeks after start of IndiTreat® Test based treatment.
“The patients enrolled in the present study is in a very difficult situation with a poor prognosis,” says Principal Investigator and Chief Oncologist Lars Henrik Jensen, University Hospital Vejle. He continues: “It is therefore a pleasure to see that we midterm has met both the technical and the interim efficacy end-points for completing the study. The present data has shown that it is feasible to tailor-make treatment using a functional test like IndiTreat®. We will continue the study and move towards a randomized trial. Long-term we hope that IndiTreat® also will be useful in earlier stages of colorectal cancer”.
“Showing that IndiTreat® leads to increased treatment efficacy in this very difficult patient group is very reassuring” states the CEO of 2cureX, Ole Thastrup. He continues “Meeting both the primary and the secondary end-points at this midterm evaluation underlines our belief in the IndiTreat® technology and means that with support from the Primary Investigators we will move the study forward towards conclusion. The positive data from the present CRC trial increases our expectations for our other IndiTreat® trials in ovarian and pancreatic cancer”.
The clinical trial is supported by a 3 MEUR grant from EU’s Horizon 2020 program.
For more information about 2cureX:
Ole Thastrup, CEO Maarten van der Linden, CBO
Phone: +45 22 11 53 99 +45 22 90 24 69
Telephone: +46 40 615 14 15
This information is information that 2cureX AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, on February 20th, 2019.
2cureX has developed a test called IndiTreat® (Individual Treatment Design), which is a patented method for selecting the right drug for the right patient. IndiTreat® establishes thousands of 3D micro-tumors that are functionally similar to the patient’s tumor. From a large panel of approved cancer treatments IndiTreat® selects the best treatment for the individual patient. IndiTreat® is expected to become a standard tool in the treatment design for cancer patients.
IndiTreat® is currently being clinically validated in colorectal, ovarian and pancreatic cancer.
The company is listed at the Nasdaq First North stock exchange in Stockholm (symbol “2CUREX”).