“`html
Hemostemix (OTCQB: HMTXF) has announced the completion of its Phase 1 basket-trial protocol, entitled “Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01),” dated October 15, 2025. This multi-center, open-label, non-randomized study aims to enroll 20–100 adults aged 40–90 with refractory severe angina. The primary objective is to assess the feasibility and safety of intracoronary ACP-01 delivery in an outpatient catheterization setting.
The trial’s secondary endpoints include monitoring chest-pain frequency, six-minute-walk distance, quality of life (QoL) and Karnofsky scores, emergency-care usage, left ventricular ejection fraction (LVEF), and functional class. Exploratory endpoints will compare the effects of one treatment versus two treatments (Day 0 and Day 90), alongside analysis of BNP as a potential predictor of treatment response.
Hemostemix (OTCQB: HMTXF) ha completato un protocollo di trial di fase 1 basket intitolato Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01) datato 15 ottobre 2025. Lo studio multicentrico, in singola mascherata? open-label, non randomizzato valuterà 20–100 adulti di età compresa tra 40 e 90 anni affetti da angina refrattaria severa per valutare la fattibilità e la sicurezza dopo la somministrazione intracoronaria di ACP-01 in un contesto di cateterismo ambulatorio.
Gli endpoint secondari includono frequenza del dolore toracico, distanza percorsa in sei minuti, QoL e punteggi di Karnofsky, uso di cure d’emergenza, frazione d’eiezione (LVEF) e classe funzionale; gli endpoint esplorativi confrontano una terapia versus due terapie (Giorno 0 e Giorno 90) e analizzano BNP come predittore.
Hemostemix (OTCQB: HMTXF) ha completado un protocolo de ensayo de fase 1 tipo basket titulado Tratamiento de la angina refractaria con precursores celulares angiogénicos (ACP-01) con fecha del 15 de octubre de 2025. El estudio multicéntrico, abierto y no aleatorizado inscribirá entre 20–100 adultos de 40 a 90 años con angina refractaria severa para evaluar la viabilidad y la seguridad tras la administración intracoronaria de ACP-01 en un entorno de cateterismo ambulatorio.
Los endpoints secundarios incluyen frecuencia de dolor torácico, distancia recorrida en la prueba de caminata de seis minutos, calidad de vida (QoL) y puntuaciones de Karnofsky, uso de atención de emergencia, LVEF y clase funcional; endpoints exploratorios comparan un tratamiento frente a dos tratamientos (Día 0 y Día 90) y analizan BNP como predictor.
Hemostemix (OTCQB: HMTXF) 은 2025년 10월 15일자 ACP-01라는 제목의 1상 바스켓 시험 프로토콜을 완료했습니다. 다기관, 공개 라벨, 비무작위 연구로 40–90세의 20–100명 성인을 모집하여 난치성 심근허혈성 협심증에 대한 ACP-01의 관상동맥 내 투여 후 외래 카테터 검사 환경에서의 타당성과 안전성을 평가합니다.
보조 평가 변수에는 흉통 빈도, 6분 보행 거리, 삶의 질(QoL) 및 Karnofsky 점수, 응급의료 이용, LVEF, 기능 등급이 포함됩니다. 탐색적 종단은 한 번 치료 대 두 번 치료(Day 0 및 Day 90)를 비교하고 BNP를 예측 변수로 분석합니다.
Hemostemix (OTCQB: HMTXF) a terminé un protocole d essai de phase 1 basket intitulé Traitement de l’Angine Réfractaire avec des Précurseurs Cellulaires Angiogéniques (ACP-01) daté du 15 octobre 2025. L’étude multicentrique, ouverte et non randomisée recrutera 20–100 adultes âgés de 40 à 90 ans souffrant d’une angine réfractaire sévère afin d évaluer la faisabilité et la sécurité après administration intracoronarienne ACP-01 en milieu de cathétérisme ambulatoire.
Les critères secondaires incluent la fréquence de la douleur thoracique, la distance parcourue lors du test de marche de six minutes, la qualité de vie et les scores de Karnofsky, l’utilisation des soins d’urgence, le LVEF et la classe fonctionnelle; les critères exploratoires comparent une versus deux traitements (Jour 0 et Jour 90) et analysent le BNP comme prédicteur.
Hemostemix (OTCQB: HMTXF) hat ein Phase-1-Basket-Studienprotokoll mit dem Titel Behandlung der refraktären Angina mit angiogenen Zellvorläuferzellen (ACP-01) datiert vom 15. Oktober 2025 abgeschlossen. Die multizentrische, offene, nicht-randomisierte Studie wird 20–100 Erwachsene im Alter von 40–90 Jahren einschließen, die an refraktärer schwerer Angina leiden, um die Machbarkeit und Sicherheit nach intrakoronarer ACP-01-Verabreichung in einer ambulanten Katheterisierungsumgebung zu bewerten.
Zu den sekundären Endpunkten gehören Brustschmerzfrequenz, Distanz beim Sechs-Minuten-Gehen, QoL und Karnofsky-Scores, Notfallversorgung, LVEF und Funktionsklasse; explorative Endpunkte vergleichen eine versus zwei Behandlungen (Tag 0 und Tag 90) und analysieren BNP als Prädiktor.
Hemostemix (OTCQB: HMTXF) أتمت بروتوكول تجربة من المرحلة الأولى من نوع Basket بعنوان علاج الذبحة الصدرية المقاومة باستخدام أسلاف الخلايا التوليدية للأوعية (ACP-01) المؤرخ في 15 أكتوبر 2025. ستجري الدراسة متعددة المراكز، مفتوحة التسمية، غير عشوائية، وشاملة 20–100 بالغاً تتراوح أعمارهم بين 40 و90 عاماً مصابين بذبحة صدرية شديدة مقاومة لتقييم الجدوى والسلامة بعد إعطاء ACP-01 داخل الشريان التاجي في إطار قسطرة خارج المستشفى.
تشمل النقاط الثانوية تكرار ألم الصدر، المسافة المقطوعة في اختبارات المشي لمدة ست دقائق، جودة الحياة وتقييم Karnofsky، استخدام الرعاية الطارئة، معدل الإفراغ القلبي EF-L؟، والفئة الوظيفية؛ تقارن النقاط الاستكشافية بين علاج واحد مقابل علاجين (اليوم 0 واليوم 90) وتحلل BNP كمؤشر تنبئي.
Hemostemix (OTCQB: HMTXF) 已完成名为 治疗难治性心绞痛的血管生成细胞前体（ACP-01） 的阶段1篮子试验协议，日期为 2025 年 10 月 15 日。该多中心、开放标签、非随机研究将招募 40–90 岁之间的 20–100 名成人，患有难治性严重心绞痛，以评估在门诊导管检查环境中经冠状动脉给药 ACP-01 的可行性和安全性。
次要终点包括胸痛频率、六分钟步行距离、生活质量（QoL）和 Karnofsky 评分、急诊护理使用、左心室射血分数（LVEF）及功能等级；探索性终点比较单次治疗与两次治疗（第 0 天和第 90 天），并将 BNP 作为预测因子进行分析。
Positive
- Planned enrollment of 20–100 adults 40–90 years
- Primary endpoints explicitly set to feasibility and safety
- Delivery method intracoronary infusion in outpatient catheterization with same-day discharge
- Exploratory two-dose arm comparing Day 0 versus Day 0 and Day 90 treatments
Negative
- Early-phase design (Phase 1) focuses on safety, not definitive efficacy
- Open-label, non-randomized design limits ability to control bias and measure causal efficacy
- No quantitative efficacy data reported in the protocol (no effect sizes or powered endpoints)
10/15/2025 – 03:51 PM
Calgary, Alberta – Hemostemix Inc. (TSXV: HEM) (OTCQB: HMTXF) (FSE: 2VF0), a biotechnology company focused on autologous stem cell therapies, announced today the completion of its clinical trial protocol for “Treatment of Refractory Angina with Angiogenic Cell Precursors (ACP-01).” This marks a significant step in the company’s efforts to provide new treatment options for patients with severe angina who have exhausted conventional medical and surgical interventions.
The Phase 1 basket trial protocol expands Hemostemix’s regenerative cardiology program, aiming to address the unmet needs of individuals experiencing persistent chest pain despite receiving optimal medical care. The company plans to seek ethics approval to commence the trial.
Angina pectoris, characterized by chest pain resulting from insufficient blood supply to the heart, is a significant symptom of ischemic heart disease. Affecting approximately five percent of adults over 40 in developed nations, refractory angina, which persists despite optimal therapy, drastically reduces patients’ quality of life, functional capacity, and increases healthcare costs. Though one-year mortality is relatively low, many patients endure disabling pain because of limited revascularization options, with current treatments primarily focused on symptom management.
Hemostemix’s ACP-01 therapy employs cells derived from the patient’s own hematopoietic lineage, engineered to form endothelial cells that release vascular endothelial growth factor (VEGF) and angiogenin. These factors promote new blood-vessel formation and micro-circulatory repair. The cell population is enriched with CD34⁺ progenitors, recognized for their role in angiogenesis. ACP-01 also expresses the CXCR4 receptor, facilitating cell homing toward CXCL12, a chemokine released by ischemic myocardium. Previous open-label trials conducted by Hemostemix in refractory angina and ischemic or dilated cardiomyopathy have indicated improved left ventricular ejection fraction (LVEF), increased six-minute-walk distances, and enhanced New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) functional class scores.
The Phase 1 multi-center study, with an open-label, non-randomized design, will enroll 20 to 100 adults, aged 40–90 years, with recurrent or refractory severe angina. ACP-01 will be administered via intracoronary injection in an outpatient setting. The primary endpoints are to establish feasibility and safety, including the incidence of adverse events. Secondary endpoints include decreases in chest-pain frequency, increases in six-minute-walk distance, improved quality-of-life (QoL) and Karnofsky performance scores, reduced emergency care needs, enhanced LVEF, and improved NYHA and CCS functional classifications. Exploratory endpoints will compare outcomes from one versus two ACP-01 treatments (Day 0 and Day 90) and will analyze serum brain natriuretic peptide (BNP) levels to assess their potential as predictors of treatment response.
The ACP-01 infusion will be guided by fluoroscopy, ensuring targeted delivery to ischemic regions and minimizing systemic exposure. Hemostemix has prior experience with this method in treating ischemic cardiomyopathy and non-ischemic dilated cardiomyopathy, demonstrating its safety and feasibility in outpatient interventional settings without procedural complications.
To ensure safety, qualified interventional cardiologists will conduct all interventions, with continuous ECG and hemodynamic monitoring. An independent Data Safety Monitoring Board (DSMB) will review adverse events and procedural data. Previous ACP-01 trials have reported no serious product-related toxicities.
According to Hemostemix’s President & CEO, Thomas Smeenk, completing the Phase 1 refractory-angina protocol builds on over two decades of data demonstrating ACP-01’s ability to stimulate blood vessel regrowth and restore circulation. This trial provides a potentially restorative therapy for patients with limited treatment options.
FAQ
What does Hemostemix (HMTXF) aim to test in the October 15, 2025 Phase 1 refractory angina protocol?
The study tests feasibility and safety of intracoronary ACP-01 in adults with refractory severe angina, with secondary measures of pain frequency, six-minute-walk distance, QoL, LVEF, and functional class.
How many patients will Hemostemix enroll in the HMTXF refractory angina Phase 1 trial?
The protocol plans to enroll between 20 and 100 adults aged 40–90 years.
How is ACP-01 delivered in the HMTXF refractory angina study and where is it performed?
ACP-01 is administered by intracoronary infusion under fluoroscopic guidance in an outpatient cardiac-catheterization setting, typically with same-day discharge.
Will Hemostemix (HMTXF) test multiple doses in the refractory angina trial?
Yes; exploratory endpoints will compare outcomes after one treatment (Day 0) versus two treatments (Day 0 and Day 90).
What are the primary endpoints for Hemostemix’s HMTXF Phase 1 refractory angina protocol?
Primary endpoints are feasibility and safety, including incidence of adverse events and procedural tolerability.
