Malmö, Sweden and Schiphol, the Netherlands (15 August 2018) – WntResearch AB (“WntResearch”) and Specialized Medical Services-oncology BV (“SMS-oncology”) announce that SMS-oncology has been selected as the contract research organization (CRO) to conduct the phase II study with Foxy-5 in patients with colon cancer.
WntResearch designed a clinical phase II trial with Foxy-5 as neoadjuvant therapy in colon cancer patients without evidence of metastases present. Their lead program Foxy-5, a small peptide that mimics the effects of Wnt-5a, is intended to compensate for the lack of protein Wnt-5a in the tumor tissue noted in patients with colon cancer, in order to reduce the risk of metastasis.
The trial will be conducted as a randomized, multicenter, controlled, open-label, two-arm trial to evaluate safety, tolerability and preliminary efficacy of Foxy-5. In addition, exploratory objectives include assessment of circulating tumor DNA (ctDNA) in subject plasma, as a surrogate for disease recurrences.
Based on the recently completed feasibility study, with a positive outcome and great interest shown by contacted research clinics, WntResearch has decided to perform the phase II study at a number of clinics in Spain and the Netherlands. The study aims to include up to 180 patients who are expected to be at high risk of recurrence in colon cancer.
SMS-oncology has been engaged for the implementation of the study owing to the expertise on conducting clinical oncology studies as well as a solid experience in carrying out studies in these two countries. Currently pre-study visits are performed and the CTA (Clinical Trial Authorization) applications will be submitted to the relevant authorities during the summer. Assuming necessary approvals, patient recruitment is expected to be initiated during the fourth quarter of 2018.
Peter Morsing, CEO at WntResearch, says: “I am very happy with the selection of SMS-oncology as our CRO. From the early beginning of contact between our companies, their in-depth oncology expertise and hands-on experience in the field was found to be of added value. The work is moving forward rapidly, and we are excited in taking these next steps with SMS-oncology as our partner.”
“The phase II study with Foxy-5 is very interesting as it has the potential to prevent and alleviate cancer invasiveness and metastasis, correlating with the poor prognosis of colon cancer patients. SMS-oncology is specialized in early phase I/ II trials and is pleased WntResearch has chosen us to implement this important clinical study”, Philine van den Tol, CEO of SMS-oncology, says.
About SMS-oncology: SMS-oncology takes pride in being a full-service Contract Research Organization (CRO) dedicated to clinical oncology studies. With our unique business model of integrating top-notch clinical operations and expert advice, we cover the whole value chain from study design to the setup, management and completion of phase I to IV oncology trials. We are specialized in early phase and immuno-oncology studies. SMS-oncology sets itself apart from typical CROs by our proactive guidance in the highly competitive and rapidly growing oncology landscape. This gives our sponsors not only a head start, but also allows our clients to be on top of the data, make informed decisions, mitigate risks and seize opportunities that arise before or during study conduct.
About WntResearch: WntResearch is developing a new type of cancer treatment based on pioneering research, which shows that the endogenous protein Wnt-5a plays a crucial role for the ability of tumor cells to relocate and spread in the body. Most patients that die of cancer do so not due to the primary tumor, but due to metastases. The need for a specific treatment to counteract metastasis is therefore in high demand.
WntResearch’s most advanced drug candidate Foxy-5 has in preclinical tests been shown to reduce the mobility of tumor cells, thereby counteracting the occurrence of metastases. The results from a completed phase Ib study in patients with colon, prostate or breast cancer, show a favorable safety and pharmacokinetic profile, as well as early indications of biological activity. The planned phase II trial will be the first in our intended target population. WntResearch is a public company listed at Spotlight in Stockholm, Sweden.
For further information: www.wntresearch.com
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WntResearch and SMS-oncology signed an agreement for the implementation of the phase II study with Foxy-5