WntResearch provides update on the preparations for the start of a Phase 2 study with the drug candidate Foxy-5
WntResearch announces today the successful completion of the process development and manufacturing of a drug formulation to be used in the continued clinical development of Foxy-5. In addition, the company has received positive preliminary results from an ongoing retrospective study, which shows that the indication for Foxy-5 in the Phase 2 study can be extended from colon cancer to colorectal cancer.
Patients treated so far with Foxy-5 have received an experimental drug formulation that complicates the logistics and is unsuitable for larger studies. WntResearch has therefore devoted considerable resources and time to securing a more effective pharmaceutical form ahead of the start of Phase 2, an effort that has now been successfully completed.
"The availability of a more suitable drug formulation will mean a lot for the continued clinical development of Foxy-5 and is expected to increase the attractiveness of the project for potential future commercial partners," says Henrik Lawaetz, CEO, WntResearch AB.
In an ongoing retrospective study, disease progression and tissue samples from patients with colon or rectal cancer are studied. The study aims at determining whether it would be suitable to extend the scope of the upcoming Phase 2 study to include patients with rectal cancer. The retrospective study has not been completed, but preliminary results indicate that Foxy-5 can be a valuable treatment for both colon and rectal cancer. In addition, the study result will serve as an important basis for determining the exact number of patients who need to be included in the Phase 2 study to reveal the treatment effect.
"It is gratifying that the preliminary results from the retrospective study point to the possibility of including patients with rectal cancer, in addition to patients with colon cancer, in the phase 2 study," says Henrik Lawaetz, CEO, WntResearch AB.
Foxy-5 is developed to reduce tumor spread. In a Phase 1b trial, the drug candidate has demonstrated a favorable safety profile, and has given clear signs of biological response. The Phase 1b results provide an important basis for selecting the dose in the Phase 2 trial, that is expected to start later this year.
For further information contact:
Henrik Lawaetz, CEO
Telephone: +46 72 702 4694
This information is information that WntResearch AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above May 17, 2017.
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 tumour cells’ ability to relocate and spread in the body. Most patients that die of cancer do so not due to the primary tumour, 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 tumour cells’ mobility and thereby counteract the occurrence of metastases. The results from a completed phase 1 study show a favourable safety and pharmacokinetic profile, as well as early indications of biological activity. A phase 1b study is currently ongoing in patients with cancer of the colon, prostate and breast. WntResearch is a public company listed at AktieTorget in Stockholm, Sweden.
For further information: www.wntresearch.com