Scandion Oncology receives final approval from the Danish Medicines Agency for start of clinical Phase II trial in patients with drug resistant metastatic colorectal cancer
Scandion Oncology A/S (“Scandion Oncology”) today announces that the company has received final approval from the Danish Medicines Agency for start of a clinical Phase II trial with the drug candidate SCO-101 in combination with chemotherapy in patients with drug resistant metastatic colorectal cancer. The study is conducted in two parts. The first interim results from this first part are expected in Q2 2020 and the final study is expected to be available by the end of 2020.
Clinical Phase II trial with SCO-101 in patients with drug resistant 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 12-18 patients to prove safety and tolerability when combining SCO-101 with chemotherapy (FOLFIRI). Patients will be treated in cohorts of 3 patients with dose escalation of SCO-101 in combination with standard dose of chemotherapy. At the last dose escalation of SCO-101 three additional patients (a total of 6 patients) will be treated. The second part of the study will start immediately after having finalized the first part since the approval from the Danish Medicines Agency also includes this second part. The second part will have efficacy as primary endpoint.
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 trial. Since the last 6 patients in the first part of the study also received the RDP2, these 6 patients will be included in the calculations of the data from the second part of the study. Patients are scanned before treatment start and then every 8 weeks during treatment.
During the Phase II trial, Scandion Oncology will validate a number of predictive and monitoring markers.
The clinical Phase II trial will be initiated as soon as the trial is authorised by a research ethics committee.
CEO Nils Brünner comments
“We are very pleased that our application for the start of a clinical Phase II trial with SCO-101 in combination with chemotherapy has been approved. This approval is confirming we are on track with this key milestone in the development of SCO-101. We are now looking forward to initiating the study. Our goal is to demonstrate Proof-of-Concept for our drug candidate in H1 2021.”
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 December 29 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 clones 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.