Additional guidelines and restrictions in Hungary and Spain, where the Neofox study is ongoing, and in the Netherlands, where the responsible CRO CATO SMS is based, have been introduced to counteract the increasing spread of the Covid-19 virus. As a result, WntResearch is adapting the level of activity related to the study, concentrating the inclusion of new patients in the NEOFOX study to hospitals that still have a continuous flow of patients. Activities at the majority of hospitals participating in the study will be limited with focus on ensuring that patients who have already started treatment complete the study protocol. The company is today estimating that these adaptations to the Covid-19 pandemic will remain in place for the next 6 months.
The very negative development of Covid-19, and the measures the company has taken due to the pandemic, greatly reduces the possibility to include patients. The company will therefore also adapt study activities with the aim of reducing costs during the period. By maintaining inclusion of patients in the hospitals that still have a continuous flow of patients, we can quickly resume active patient recruitment when the impact of the pandemic decreases. The adjustments that are now being implemented by the company will result in an extended timeline for the completion of the NEOFOX study. WntResearch continues to follow developments closely and maintains a close dialogue with all stakeholders in order to recruit patients in accordance with current guidelines.
Currently, 28 clinics in Spain and Hungary are participating in the NEOFOX study targeting patients with stage 3 colon cancer. The patients are randomized to two equal groups where one group receives treatment with Foxy-5 before and after surgery until the patient begins standard of care treatment. To date, 55 patients have been included in the NEOFOX study and we see great interest from treating physicians and patients to participate in the evaluation of Foxy-5.
Coordinating Investigator in NEOFOX, Dr Ramon Salazar, commented "I view the development of Foxy-5 as a potential new drug candidate for the treatment of colon cancer very positively. Due to the Covid-19 pandemic the measures that WntResearch is now implementing are absolutely necessary, although this unfortunately means that the inclusion of patients will be further delayed. Together with WntResearch, I look forward to optimising the conduct of the study and to create the best conditions for further inclusion of patients to generate the necessary data to evaluate Foxy-5's potential to counteract the spread of colon cancer ".
Anders Rabbe, CEO of WntResearch, comments: "Since the outbreak of the covid-19 pandemic, WntResearch top priority has been to ensure the safety of patients, healthcare professionals, employees and providers involved in the NEOFOX study. We are now implementing drastic but necessary measures to adapt our operations to new guidelines and restrictions. We also reduce all activities in the study to a minimum to run our operations as cost-effectively as possible. We will carefully evaluate what long-term consequences the implemented measures will have on the study program with Foxy-5, and proactively implement actions to counteract these. The period, when activities around the study are limited, will be used to ensure the completion of the study. Together with investigators and our partners, we will evaluate opportunities to further optimise the study protocol to facilitate patient inclusion and ensure that the study generates maximum information about Foxy-5 as a basis for further development towards a future possible market registration".
For more information, please contact:
Anders Rabbe, CEO, WntResearch AB
Telephone: +46 (0)707 646500
This information is information that WntResearch 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 Thursday, 3 December 2020.
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
 Clinical research organisation
 Random division in two or more groups