Clinical Trials

Multiple clinical trials sponsored exclusively by WntResearch AB evaluate Foxy-5 across Phase 1 and Phase 2 studies targeting advanced solid tumors, specifically metastatic breast, colorectal, and metastatic prostate cancers. Completed early-phase trials assessed the safety, pharmacokinetics, and pharmacodynamics of the compound. Additionally, Phase 2 clinical research has been initiated to evaluate Foxy-5 as a neo-adjuvant treatment specifically for patients with colon cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03883802 UNKNOWN
Colon Cancer
WntResearch AB
2019-04-12 PHASE2
NCT02655952 COMPLETED
Metastatic Breast Cancer; Metastatic Colon Cancer; Metastatic Prostate Cancer
WntResearch AB
2016-04 PHASE1
NCT02655952 Completed
Metastatic Breast Cancer|Metastatic Colon Cancer|Metastatic Prostate Cancer
WntResearch AB
2016-04 Phase 1
NCT02020291 COMPLETED
Metastatic Breast Cancer; Colorectal Cancer; Prostate Cancer
WntResearch AB
2013-06 PHASE1
NCT02020291 Completed
Metastatic Breast Cancer|Colorectal Cancer|Prostate Cancer
WntResearch AB
2013-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2022-12-09)

Check the Foxy-5 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a Wnt-5a mimicking hexapeptide, Foxy-5 binds to WNT receptor complexes and activates non-canonical WNT signaling pathways, which disrupts the cytoskeletal dynamics required for cellular migration and invasion. This suppression of tumor cell dissemination provides the mechanistic basis for inhibiting cancer cell spread in clinical indications such as metastatic breast cancer, colorectal cancer, and prostate cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.