Scandion Oncology A/S (“Scandion Oncology”) today announces that the company has submitted an application to the Danish Medicines Agency for permission to conduct a clinical Phase II study in patients with metastatic colorectal cancer. Scandion Oncology is thus following the timelines presented in the prospect. The study will be initiated at hospitals in Denmark. The clinical Phase II study will be conducted in two parts, and provided that the study is approved in the fourth quarter of 2019, the first data are expected in Q2 2020 and the final study report will be released in H1 2021.
Clinical Phase II trial with SCO-101 in patients with metastatic colorectal cancer
Scandion Oncology’s first clinical Phase II study with SCO-101 (“A Phase 2 Trial of SCO-101 in combination with FOLFIRI for Patients with Metastatic Colorectal Cancer (mCRC) with acquired Resistance to FOLFIRI”) will be divided into two parts where the first part includes 12-15 patients to prove safety and tolerability when combining SCO-101 with chemotherapy (FOLFIRI).
The data from the first part will form the basis for defining the recommended dose for phase II (RDP2), which means the dose of SCO-101 in combination with standard dose of chemotherapy to be used in the second part of the phase II study. During the phase II study, Scandion Oncology will validate a number of predictive and monitoring markers.
CEO Nils Brünner comments
“We have spent a lot of efforts and time making sure that the trial design is optimal and by introducing predictive biomarkers, the likelihood of a successful outcome is increased. SCO-101 treatment will thus follow a personalized medicine concept. Based on the outcome of the clinical study Scandion Oncology has the ability to deliver a new drug to the market, one that can help overcome chemotherapy resistance.”
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 October 1, 2019.
Scandion Oncology A/S is a biotechnology company founded in 2017 for the purpose of addressing and tackling one of the greatest challenges in modern oncology – the effective treatment of cancer which contains drug resistant cell or which has developed resistance to a previously prescribed cancer-fighting drug. In preclinical in vitro-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 ready to initiate clinical phase II trials with its lead compound, SCO-101 in patients with drug resistant cancer. Scandion Oncology was listed on Spotlight Stock Market, Sweden in November 2018.