Clinical Trials

Several clinical trials spanning Phase 1, Phase 1/2, and Phase 2 have evaluated balixafortide in healthy volunteers as well as patients with advanced breast cancer, metastatic breast cancer, large reperfused ST-elevation myocardial infarction, and multiple myeloma. Sponsored primarily by Polyphor Ltd. alongside MedSIR, these studies evaluated therapeutic combinations—such as balixafortide with eribulin—and progenitor cell mobilization. While most trials have been completed, a Phase 1/2 combination study in advanced breast cancer was withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04826016 Withdrawn
Advanced Breast Cancer
MedSIR
 2022-03-16 Phase 1|Phase 2
NCT01905475 Completed
Large Reperfused ST-Elevation Myocardial Infarction
Polyphor Ltd.
 2013-07 Phase 2
NCT01837095 Completed
Metastatic Breast Cancer
Polyphor Ltd.
 2013-06 Phase 1
NCT01841476 Completed
Healthy
Polyphor Ltd.
 2012-02 Phase 1
NCT01105403 Completed
Multiple Myeloma
Polyphor Ltd.
 2009-04 Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Balixafortide (POL6326) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Balixafortide functions as a peptidic antagonist of CXC chemokine receptor 4 (CXCR4), selectively binding the receptor to prevent its activation by CXCL12 and block downstream intracellular signaling cascades. By inhibiting CXCR4-driven cell adhesion and chemotaxis, this blockade disrupts tumor-microenvironment trafficking and mobilizes progenitor cells into peripheral circulation, providing the rationale for its clinical investigation in metastatic breast cancer, multiple myeloma cell mobilization, and myocardial infarction repair.

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>).

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