Scandion Oncology announces that the Clinical Trial Application for a pancreatic cancer study with chemotherapy and SCO-101 has been submitted to the Danish Medicines Agency and the Ethical Committee.
Scandion Oncology A/S (“Scandion Oncology”) is pleased to announce that a Clinical Trial Application (CTA) has been submitted to the Danish Medicines Agency and the Ethical Committee. A response is expected within 60 days.
Pancreatic cancer is one of the most aggressive cancer forms with almost 75% of patients presenting with chemotherapy resistant disease. Due to this resistance, very few pancreatic cancer patients will be long-term survivors. A drug that reverses chemotherapy resistance in pancreatic cancer and other cancer forms will obviously have a significant commercial potential.
Scandion Oncology together with Danish clinical partners have now submitted a CTA where patients with metastatic or inoperable pancreatic cancer in the first part of the trial will receive chemotherapy (Nab-paclitaxel plus gemcitabine) plus increasing doses of SCO-101. The primary objectives of this part one of the trial are safety, toxicity and efficacy and definition of optimal dose of SCO-101. When a safe dose of SCO-101 when combined with chemotherapy is defined, Scandion Oncology will initiate part two, which is a randomized clinical trial where pancreatic cancer patients are randomized between chemotherapy (Nab-paclitaxel plus gemcitabine) versus chemotherapy combined with SCO-101 (Nab-paclitaxel, gemcitabine and SCO-101). The primary endpoints of the randomized, second part of the trial are progression-free survival, overall survival and clinical benefit rate.
Scandion Oncology have previously reported that it has received a grant on DKK 5 mill from Innovation Fund Denmark to support this pancreatic cancer study.
Nils Brünner, CEO comments: “I am very pleased that despite the Covid-19 pandemic we have been able to keep our timelines and submitted the CTA for the pancreatic cancer trial as planned. At the same time we have identified the clinical oncology departments that will run the pancreatic cancer study. I expect that the first patient will be included in the trial during September-October 2020.
For further information regarding Scandion Oncology, please contact:
Nils Brünner, CEO
Phone: +45 26 14 47 08
E-mail: nb@scandiononcology.com
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 June 9, 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 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 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.