Scandion Oncology receives final approval from the Danish Medicines Agency and Ethical Committee for start of a clinical trial in patients with pancreatic cancer
Scandion Oncology A/S (“Scandion Oncology”) today announces that the company has received final approval from the Danish Medicines Agency and Ethical Committee to initiate a clinical trial with the drug candidate SCO-101 in combination with first line chemotherapy in patients with inoperable or metastatic pancreatic cancer. This is the second clinical trial with SCO-101 that will commence in 2020. Results from this trial are expected in Q2-Q3, 2021
Clinical testing of SCO-101 in combination with chemotherapy as first line treatment for inoperable or metastatic pancreatic cancer.
Scandion Oncology’s second clinical trial with SCO-101 in combination with chemotherapy will initially include 12-18 patients in a dose-range finding study to prove safety and tolerability when combining SCO-101 with the chemotherapeutic drugs Nab-paclitaxel and gemcitabine, the latter being standard first line treatment for pancreatic cancer patients. Patients will be treated in cohorts of 3 with dose escalation of SCO-101 in combination with standard dose of chemotherapy and the trial will start during October 2020.
The data from this dose-range finding study will form the basis for defining the recommended dose of SCO-101, which means the dose of SCO-101 in combination with standard dose of chemotherapy to be used in a subsequent randomized phase II study in pancreatic cancer. In the phase II trial, patients will be randomized to receive standard chemotherapy +/- SCO-101. Patients are scanned before treatment start and then every 8 weeks during treatment for evaluating clinical efficacy of SCO-101as an add to chemotherapy
During this clinical trial, Scandion Oncology will validate a number of biomarkers relevant for selecting patients for SCO-101 treatment and monitoring efficacy of the treatment.
Scandion Oncology CEO, Nils Brünner comments
“We are very pleased that our application now has been approved. This means that we shortly will start our second clinical trial in 2020. This new clinical trial will investigate the effect of SCO-101 in combination with chemotherapy in pancreatic cancer patients. Of special importance is that with this second clinical trial, this time in pancreatic cancer patients, we are testing the possibility of moving SCO-101 to first line treatment – potentially allowing a commercially very attractive positioning in the oncology market.
This pancreatic cancer trial with SCO-101 will start in October 2020 and final results from the dose-range finding part will be available in Q2-Q3, 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 with the EU Market Abuse Regulation. The information was provided by the contact person above for publication on September 28, 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: www.scandiononcology.com.
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