· Scandion Oncology and The Danish Medicines Agency have had a very positive and constructive meeting, where Scandion Oncology’s plans for the upcoming clinical phase II study of SCO-101, in combination with chemotherapy in patients with drug resistant metastatic cancer study, were discussed.
· The Danish Medicines Agency has confirmed that no further non-clinical studies are required to initiate the planned phase II clinical study, and only minor comments were given to the dosing schedule of SCO-101 proposed by Scandion Oncology.
Following a successful meeting with The Danish Medicines Agency, Scandion Oncology will continue the planning of the company’s phase II study, incorporating the minor improvements suggested. Also, The Danish Medicines Agency has supplied Scandion Oncology with important and excellent recommendations for future clinical trials with SCO-101 in combination with anti-cancer drugs.
The first patient is planned to enter into phase II study in Q4, 2019, which is in accordance with Scandion Oncology’s plans and targets for 2019.
CMO of Scandion Oncology, Dr. Peter Michael Vestlev:
We are pleased by the outcome of this meeting, which constitutes one of the most important milestones for Scandion Oncology to pass. We are now able to continue our work on submitting our application for initiating a clinical phase II study with SCO-101 in combination with chemotherapy.”
The Danish Medicines Agency forms part of the Danish Ministry of Health. Among other things the agency authorises and inspects pharmaceutical companies and licenses medicinal products in the Danish market.
For further information regarding Scandion Oncology, please contact:
Nils Brünner, CEO
Phone: +45 26 14 47 08
E-mail: nb@scandiononcology.com
http://www.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 March 26, 2019.
About Scandion Oncology A/S
Scandion Oncology A/S is a biotechnology company founded in 2017 with 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 animal studies, the company’s leading candidate drug, SCO-101, has been found to significantly enhance the efficacy of certain standard cancer treatments when given in combination. It has been shown in in vitro-studies that SCO-101 restores chemotherapy sensitivity in resistant cells. Scandion Oncology was listed on Spotlight Stock Market, Sweden, in November 2018.