ACP-01
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Hemostemix Expands Phase 1 Trial to Include Refractory Angina
Hemostemix (HMTXF) has completed its Phase 1 trial protocol for refractory angina using ACP-01. This open-label study will enroll 20-100 adults with severe angina to assess the feasibility and safety of intracoronary ACP-01 delivery in an outpatient setting. Secondary endpoints include monitoring chest pain, six-minute walk distance, quality of life, and LVEF. The trial will also explore the effects of single versus double treatments and analyze BNP levels to predict treatment response.
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Hemostemix Submits FDA Filing 1517 for ACP-01 (VesCell™) Basket Protocol Targeting Multiple Ischemic and Vascular Indications
Hemostemix (HMTXF) filed an FDA Pre-IND application for a Phase I basket trial of ACP-01 (VesCell™) to evaluate its safety and early efficacy across vascular dementia, peripheral arterial disease, angina, cardiomyopathy, and congestive heart failure. Hemostemix aims to use real-world evidence from Florida, where ACP-01 is available, to support regulatory advancement. The company has completed 498 safe treatments and has 11 peer-reviewed publications. The basket protocol seeks to accelerate development and expand target markets.
