The analysis of circulating tumour DNA will be postponed due to COVID-19, as the clinics in Spain have had limited opportunities to carry out the planned blood sampling
Since the NeoFox study was put on hold in March 2020, the clinics have had limited possibilites to carry out follow-up blood sampling of patients included in the study. As a result, a number of blood samples which are critical for the planned analysis of circulating tumour DNA could not be collected. WntResearch has now restarted the NeoFox study in Spain, but the COVID-19 situation is still posing problems in both Hungary and Spain, and the inclusion of new patients thus remains slow.
The Spanish authorities have recently changed their recommendations, and decisions regarding clinical trial activities have been delegated to individual hospitals. Following discussions with Dr. Salazar, the study's principal investigator, WntResearch has decided to restart the study in Spain. The aim is to include new patients and carry out follow-up sampling of all treated patients every three months as a basis for the important subsequent analysis of circulating tumour DNA (ctDNA).
When the restrictions pertaining to clinical trials where lifted by the Hungarian authorities, the plan was to quickly resume the study and restore the inclusion rate. Due to further COVID-19 outbreaks, these expectations have not yet been met. WntResearch is monitoring the situation closely and is making every endeavour to accelerate recruitment to the study. There are currently four patients included in the Hungarian study.
WntResearch will carry out an analysis of ctDNA from the included patients when a sufficient number of samples to permit meaningful analysis has been collected. Whether this can be done next summer will be determined by the number of new patients included during fall. As WntResearch now has resumed the study, patients whose sampling was previously put on hold are reverting to follow-up and 3 month sampling.
"We have to accept that the pause caused by the acute COVID-19 situation has forced us to postpone our initial analysis until enough 6, 9 and 12 month samples are available," says Peter Morsing.
For more information, please contact:
Peter Morsing, CEO, WntResearch AB
E-mail: pm@wntresearch.com
Telephone: +46 727 200711
This information is information that SpectraCure AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on 24 September 2020.
About WntResearch
WntResearch is a research and development company in oncology that develops new treatments intended to inhibit metastasis formation in cancers. The Company focuses on WNT5A, a protein that suppresses the metastatic process in the body; the vision is for cancer patients to no longer have to endure metastasis. Today, one in every three people will develop cancer during their lifetimes, and 90 percent of all cancer-related deaths are caused by metastases. Even though cancer treatment has become more effective, there are no effective methods to prevent the formation of metastasis. The drug candidate Foxy-5 mimics WNT5A’ s ability to reduce the mobility and thus the spread of cancer cells. Foxy-5 has demonstrated a good safety profile with few adverse effects in two clinical phase I studies. An ongoing clinical phase II study is currently being conducted on patients with colon cancer with the Company's drug candidate Foxy-5. According to the Company's assessment, Foxy-5 is the only drug candidate of its kind, with a unique mode of action in an area where other drug or treatment options are lacking. WntResearch’s share is listed on Spotlight Stock Market. For more information, please visit: www.wntresearch.com