Hemostemix seeks to treat refractory angina

Executive Summary

• Hemostemix Inc. has completed drafting a Phase 1 basket protocol to evaluate its autologous stem‑cell therapy (ACP‑01) in patients with refractory angina.
• The study will enroll 20–100 adults, deliver ACP‑01 via intracoronary injection, and assess feasibility, safety, and multiple efficacy endpoints (pain frequency, six‑minute walk distance, LVEF, NYHA/CCS class, quality of life).
• This protocol filing moves the company’s regenerative cardiology program toward a first‑in‑human trial for a high‑unmet‑need patient population.

Key Details

• Protocol Title: “Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP‑01)”.
• Study Design: Phase 1, multicentre, open‑label, non‑randomized basket trial.
• Target Population: 20–100 adults, ages 40–90, with recurrent or refractory severe angina despite maximal medical and surgical therapy.
• Intervention: Autologous ACP‑01 cells administered by intracoronary injection in an outpatient cardiac catheterization setting; optional second dose on Day 90 for a subset of patients.
• Primary Endpoints: Feasibility and safety (incidence of adverse events).
• Secondary Endpoints: Reduction in chest‑pain frequency, increase in six‑minute‑walk distance, improvement in quality‑of‑life and Karnofsky performance scores, decreased emergency visits, improved left‑ventricular ejection fraction (LVEF), better NYHA and CCS functional classifications.
• Exploratory Endpoints: Comparison of outcomes between one vs. two ACP‑01 treatments; serum BNP levels as predictors of response.
• Safety Oversight: Continuous ECG/hemodynamic monitoring by interventional cardiologists; independent Data Safety Monitoring Board to review adverse events.
• Rationale: ACP‑01 cells are CD34⁺ progenitor‑rich, express CXCR4 for homing to ischemic myocardium, and secrete VEGF and angiogenin to promote neovascularization. Prior open‑label studies showed improvements in LVEF, six‑minute‑walk distance, and functional class.
• Quote: “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.

Notable Quotes

• “For patients living with daily chest pain who have no other options, this trial represents a meaningful step toward a restorative, rather than purely palliative, therapy.” – Thomas Smeenk, President & CEO, Hemostemix Inc.