The COVID-19 pandemic is heavily affecting the resources at the hospitals and health care systems – also in Denmark. The Danish Health Authorities, the European Medicines Agency (EMA) and the US Federal Drug Administration (FDA) recommends that all First in Man (FIM) clinical studies with novel single agents or novel combinations, should be considered postponed until the COVID-19 pandemic is under control. However, as described in the COVID-19 guidance from EMA: “Sponsors should be mindful of the current pressure on the medical profession and should carefully assess the pertinence of adding new subjects in ongoing clinical trials. Absolute priority should be given to clinical trials on treatments for COVID-19 and COVID-19 related illnesses, or trials on serious diseases with no satisfactory treatment option."
The current phase II study with SCO-101 in combination with FOLFIRI for treatment of FOLRIRI resistant metastatic colorectal cancer patients includes the FIM combination of SCO-101 and FOLFIRI chemotherapy regimen. The cancer patients that are eligible to this study have a serious metastatic cancer disease with very few other treatment options. In collaboration with our clinical partners at the hospitals, Scandion Oncology has therefore decided to continue the study with SCO-101 in FOLFIRI resistant colorectal cancer patients.
CEO Nils Brünner comments
“The safety and well-being of the patients are the most important priority of Scandion Oncology. As long as the current situation requires the full capacity of our health care system, it is not possible to predict the number of patients that will be enrolled in the coming months and some patients could experience that enrolment in the study may be postponed due to the COVID-19 pandemic. At Scandion Oncology we are continually assessing the risks and impact on the clinical activities with SCO-101 related to COVID-19”.
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 March 23, 2020.
Scandion Oncology A/S is a biotechnology company that addresses and tackles 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. In addition to SCO-101 the Company has two other drug candidates, SCO-201 and SCO-301. Scandion Oncology was listed on Spotlight Stock Market, Sweden in November 2018.