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2018-08-15

WntResearch: SMS Oncology publicerar idag  om samarbetet för genomförandet av fas 2-studien med Foxy-5, vilket WntResearc...

WntResearch and SMS-oncology signed an agreement for the
implementation of the phase II study with Foxy-5

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

For more information, please refer to www.sms-oncology.com

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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http://news.cision.com/se/wntresearch/r/sms-oncology-publicerar-idag--om...
http://mb.cision.com/Main/11610/2592870/891761.pdf

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