Hemostemix Adds the Treatment of Refractory Angina to Its Phase 1 Basket Protocol

Executive Summary

• Hemostemix Inc. completed drafting its Phase 1 basket clinical‑trial protocol titled “Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP‑01).”
• The trial will enroll 20–100 adults with refractory angina and evaluate safety, feasibility, and multiple efficacy endpoints (pain frequency, six‑minute walk distance, LVEF, QoL, etc.).
• Intracoronary delivery of autologous ACP‑01 cells will be performed in an outpatient cardiac‑catheterization setting under DSMB oversight.

Key Details

• Protocol Status: Draft completed; company will seek ethics approval to commence the study.
• Indication: Refractory angina (patients with persistent chest pain despite maximal medical/surgical therapy).
• Study Design: Phase 1, multi‑center, open‑label, non‑randomized; 20–100 participants aged 40‑90 years.
• Dosing Regimen: Intracoronary injection of ACP‑01 on Day 0; optional second dose on Day 90 for a subset of patients (exploratory arm).
• Primary Endpoints: Feasibility and safety – incidence of adverse events, procedural complications.
• Secondary Endpoints: Reduction in chest‑pain frequency, increase in six‑minute‑walk distance, improvement in LVEF, better NYHA/CCS functional class, QoL (Karnofsky) scores, reduced emergency visits.
• Exploratory Endpoints: Comparison of one vs. two ACP‑01 treatments; serum BNP as a predictive biomarker.
• Delivery Method: Intracoronary infusion via catheter under fluoroscopic guidance; procedure lasts ~1 hour with same‑day discharge.
• Safety Oversight: Conducted by qualified interventional cardiologists with continuous ECG/hemodynamic monitoring; independent Data Safety Monitoring Board (DSMB) to review all adverse events.
• Prior Evidence: Earlier open‑label trials showed improved LVEF, longer six‑minute‑walk distances, and better NYHA/CCS classifications in refractory angina and cardiomyopathy patients.

Notable Quotes

“Completing our Phase 1 refractory‑angina protocol builds directly on more than two decades of real‑world data showing ACP‑01’s ability to regrow blood vessels and restore circulation,” said Thomas Smeenk, President & CEO of Hemostemix.

Materiality Assessment: Non‑Material – Positive (the announcement is forward‑looking and does not yet disclose financial results or definitive clinical outcomes, but it signals a potentially material development pipeline step).