15 February 2018 - - After reviewing available research results and further consultations with experts in oncology and surgery, Stockholm, Sweden-based cancer treatment developer WntResearch AB has revised the design of the planned Phase 2 clinical study of its drug candidate Foxy-5, the company said.
The revised study design is considered to optimize the treatment effect of Foxy-5, but will delay the study initiation compared to the previous estimate (year-end 2017/18).
However, the impact on the overall timeline of the study is largely offset by the fact that no dose titration of Foxy-5 will be necessary, as co-treatment with Folfox, a standard chemotherapy regimen, is no longer planned in the study.
The revised study design is based in part on results of the completed phase 1b study, together with information from a retrospective study of patients with colon cancer in tumor stage III.
Patients with stage III tumors have tumor cells in lymph nodes adjacent to the primary tumor, thereby being more aggressive and faster progressing.
Foxy-5 is intended to compensate for the deficiency of protein Wnt-5a in tumor tissue noted in patients with colon cancer, in order to reduce the risk of metastasis.
WntResearch is now collecting supplementary quotes from contract research organizations (CROs). After selection of a preferred CRO, the study will start as soon as relevant ethics committees and regulatory authorities have given their approvals.
WntResearch is developing a new type of cancer treatment based on research showing that the endogenous protein Wnt-5a plays a crucial role in the ability of tumor cells to metastasize.
In preclinical tests, the company's most advanced drug candidate, Foxy-5, has been shown to reduce the mobility of tumor cells, thereby counteracting the occurrence of metastases.
The results from a completed phase 1b study in patients with colon, prostate or breast cancer, show a favorable safety and pharmacokinetic profile, as well as early indications of biological activity.