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Update on 2cureX’s clinical trial in metastatic colorectal cancer: 75% of the scheduled patients have been treated in accordance with the IndiTreat test

2020-01-30

Press Releases

2cureX AB (“2cureX”, NASDAQ: 2CUREX) is pleased to announce that 35 patients have been treated in accordance with the IndiTreat test in our colorectal cancer trial (ClinicalTrials.gov Identifier: NCT03251612). We are thus on track and expect that all the planned 45 patients are treated by Q3, 2020.

The clinical trial was initiated by Vejle University Hospital, selected by “Dagens Medicin” as the best cancer hospital in Denmark for four consecutive year

Lars Henrik Jensen, Chief Oncologist and Chairman of Interdisciplinary Oncology Committee of the Danish Medicines Council, is the Principal Investigator and Sponsor of the trial.

Patients enrolled in this trial had previously been treated with first and second lines of guideline-based chemotherapy for colorectal cancer with metastatic spread to the liver. The most effective treatment identified with the IndiTreat test will be provided to the patients as third line treatment. The efficacy of the IndiTreat guided treatment is evaluated after eight weeks by a CT scan according to the RECIST criteria.

The results of the present clinical trial will be presented and published by the Principal Investigator when 45 patients treated according to the IndiTreat test have completed eight weeks of therapy and a CT scan. With the current patient inclusion rate, it is expected that the trial will be finalized in the third quarter of 2020.

IndiTreat is measuring the growth of a particular patient’s tumor and identifies which drug will kill the cancer cells most effectively

For the IndiTreat test, a biopsy is taken from the patient’s liver metastasis. Hundreds of small micro-tumors (tumoroids) with the same properties as the patient’s metastasis are generated from this biopsy. The tumoroids are then exposed to a variety of different cancer drugs to identify those that best inhibit the growth of the patient’s tumor. Most of these drugs are approved for treatment of other cancers than colorectal but can prove to be effective.

A new era of Precision Medicine

For several years Personalized Treatment or Precision Medicine has been synonymous with choosing drugs based on a genomic mutational analysis of a patient’s tumor, so-called Genomic Precision Medicine. However, the molecular mechanisms and mutations that lead to cancer development are very incompletely known and only a few of the mutations can be targeted by the drugs available today. As a consequence, less than 5% of cancer patients undergoing genetic testing have a mutation that can respond to a treatment with a targeted drug.

Henrik Harling, Chief Medical Officer in 2cureX, says: “It has gradually become clear that genetic testing cannot stand alone as a tool for Precision Medicine. Functional Precision Medicine is based on a direct observation in the lab, of the effects of a wide range of drugs on a patient´s tumor. It looks at what works, and the mutational status is basically inferior. IndiTreat is precisely such a Functional Precision Medicine tool and we are eagerly awaiting the results of the Vejle study. In the future, Precision Medicine may likely involve both genetic and functional methods to make a substantial difference for the cancer patients that need medical treatment”.

For more information about 2cureX:

Ole Thastrup, Chief Executive Officer
E-mail: ot@2curex.com
Telephone: +45 2211 5399
www.2curex.com

Certified Adviser:

Svensk Kapitalmarknadsgranskning AB
Email: ca@skmg.se
Phone: +46 11 32 30 732

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About 2cureX

2cureX has developed the IndiTreat® (Individual Treatment) test. IndiTreat® establishes thousands of 3D micro-tumours that are similar to the patient’s tumour and identifies the treatment that most effectively kills the patient’s tumor. Immediately after the test, the patient can be offered the selected treatment.

IndiTreat® is being clinically validated in clinical studies in colorectal cancer, ovarian cancer, pancreatic cancer and preventive cancer medicine. The clinical programs are conducted at major cancer hospitals in Denmark, Germany and United Kingdom.

IndiTreat® is presently being introduced into the European market through an Early Access Program.

IndiTreat® is expected to become a standard tool in Precision Medicine for cancer patients.

The company is listed at the Nasdaq First North Growth Market in Stockholm (symbol “2CUREX”).

 

Contact information

2cureX, Fruebjergvej 3, 2100 Copenhagen Ø, Denmark| Phone: +45 2211 5399| E-mail: info@2curex.com

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