Scandion Oncology A/S (“Scandion Oncology”) reports on data from the first cohort of chemotherapy resistant colorectal cancer patients treated with SCO-101 and chemotherapy (FOLFIRI). All patients in the first cohort have now completed at least one treatment cycle (14 days). The main result is that 150 mg daily oral SCO-101 potentiates the effects of chemotherapy (FOLFIRI). Based on the safety data from this first cohort of patients, the Data Safety Monitoring Board has recommended to include 3 additional patients at 150 mg SCO-101 in order to get more details on the interactions between SCO-101 and FOLFIRI.
The patients included are patients with late stage metastatic colorectal cancer, for whom no additional treatment is available. All patients have previously had benefit with FOLFIRI (chemotherapy) treatment but subsequently, their cancer started to grow or the patient showed new metastatic lesions and they were offered to be enrolled in the Scandion Oncology clinical phase II trial. The primary objective of the trial is to establish the safety, tolerability and Maximum Tolerated Dose of SCO-101 in combination with FOLFIRI chemotherapy, and by the addition of SCO-101 to re-establish treatment benefits of FOLFIRI.
Data from the first patients treated in cohort 1 showed, (i) SCO-101 at a daily oral dose of 150 mg for 6 days results in the expected transient increase of the exposure biomarker bilirubin. This transient increase in bilirubin is of no clinical significance; (ii) SCO-101 potentiated the effects of FOLFIRI on white blood cells; (iii) SCO-101 dosed in combination with FOLFIRI decreases blood concentrations of the liver enzymes ASAT and ALAT. ASAT and ALAT are enzymes released from damaged liver cells; (iiii) All patients are assessed at 8 week intervals by a CT-scan for status on their disease. Due to the early stage of the trial, only one patient has currently completed 8 weeks treatment. This first patient showed stabilization of his cancer disease and has therefore continued treatment. Additional PRs regarding the efficacy end-points will be published at a later time point when we have more data.
CEO Nils Brünner says “”The possibility to reverse chemotherapy resistance is groundbreaking, giving countless patients worldwide a new chance in life; Scandion Oncology is therefore very pleased to present the results of our first patients treated with SCO-101 in combination with chemotherapy. The most important observation at this early stage is that an oral dose of 150 mg SCO-101 combined with chemotherapy appears to be biological active as measured by potentiating a decrease in white blood cells, in transiently increasing the blood level of bilirubin, reducing the blood level of liver enzymes and by inducing stable cancer disease in the first patient. That 150 mg SCO-101 is biologically active in cancer patients is in line with our many preclinical data. As soon as we have reached the recommended dose of SCO-101 for phase II when given together with chemotherapy, we will start the second part of the phase II study where treatment efficacy is the primary end-point”.
A more detailed description of the results will be available for potential partners.
For further information regarding Scandion Oncology, please contact:
Nils Brünner, CEO
Phone: +45 26 14 47 08
This information is information that Scandion Oncology is obliged to publish in accordance to the EU Market Abuse Regulation. The information was provided by the contact person above for publication on July 31, 2020.
Scandion Oncology A/S is a biotechnology company that addresses and targets one of the greatest challenges in modern oncology – the effective treatment of cancer which contains chemotherapy-resistant cells or which has developed resistance to a previously prescribed cancer-fighting drug. In preclinical studies, SCO-101 restores chemotherapy sensitivity in resistant cancer cells. Moreover, in animal studies, the company’s leading candidate drug, SCO-101, significantly enhances the efficacy of certain standard cancer treatments when given in combination. Scandion Oncology is now in clinical phase II trials with its lead compound, SCO-101, in patients with chemotherapy-resistant colorectal cancer. Scandion Oncology was listed on Spotlight Stock Market, Sweden in November 2018. For further information, please see: http://www.scandiononcology.com.