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Business Wire
10-07-2025
- Health
- Business Wire
First Patient Dosed in XyloCor Therapeutics' Phase 2b EXACT-2 Trial Evaluating XC001 for the Treatment of Coronary Artery Disease
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--XyloCor Therapeutics, a clinical-stage biopharmaceutical company focused on developing novel therapies for cardiovascular disease, announced the first patient has been dosed in the Phase 2b EXACT-2 trial, designed to evaluate its gene therapy candidate XC001 (encoberminogene rezmadenovec) in individuals with coronary artery disease and refractory angina. XC001 is an adenoviral vector-based gene therapy encoding for vascular endothelial growth factor (VEGF), uniquely designed as a one-time catheter-based treatment to reduce cardiac ischemia by creating new blood vessels in the heart and thereby reducing episodes of chest pain and improving patient ability to perform everyday activities. This percutaneous administration approach, injecting directly into the heart muscle, allows XC001 to achieve higher gene expression levels locally in the heart while minimizing systemic vector circulation and associated side effects. 'Initiating the EXACT-2 trial is an important milestone as we continue to develop XC001 for the treatment of refractory angina in patients who have exhausted available treatment options and have a debilitating quality of life,' said Albert Gianchetti, President and CEO of XyloCor. 'Building on the positive results from EXACT-1, we are now focused on advancing the EXACT-2 trial to bring this potentially transformative treatment to patients as quickly as possible.' EXACT-2 is a Phase 2b, multicenter, randomized, double-blind study in 100 patients with refractory angina to evaluate the safety and efficacy of a one-time gene therapy with XC001, delivered using the Extroducer ® Infusion Catheter System, an endocardial delivery catheter designed to inject advanced therapies directly into the heart in a simple injection procedure in the cardiac catheterization lab. Additional information can be found here. The first patient was dosed by Timothy Henry, MD, at The Christ Hospital Health Network in Cincinnati, OH. 'After seeing the convincing results from the EXACT-1 trial, we were eager to participate in EXACT-2,' commented Dr. Timothy Henry, a cardiovascular interventionist and the Lindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for Research at The Christ Hospital. 'We believe that XC001 delivered through the Extroducer ® Infusion Catheter System will maintain the accuracy of delivery of XC001 to the heart and improve the safety over the surgical administration approach used in EXACT-1.' The XC001 Phase 1/2 EXACT-1 trial results supported the transformative, disease-modifying potential of XC001 to reduce cardiac ischemia, reduce anginal symptoms and improve the quality ‑of ‑life for cardiac patients who have no other treatment options. The results demonstrated the potential for XC001 to be safely administered and achieve durable clinical improvements, including increases in exercise duration, decrease in ischemic burden as measured by Positron Emission Tomography (PET) imaging and a reduction in angina frequency. Notably, 93% of patients in the trial entered with chest pain so severe that it markedly limited daily activities, whereas at six months 43% reported no chest pain with ordinary activities. XC001 was well tolerated in the patient population and there were no serious adverse events related to the study drug. XyloCor is also initiating a second clinical trial this year – a double-blind Phase 2 trial of XC001 as an adjunctive treatment to coronary artery bypass graft surgery (CABG). About XC001 XC001 is designed to reduce cardiac ischemia by creating new blood vessels in the heart that will bypass diseased blood vessels and improve blood flow. By restoring blood flow, chest pain associated with refractory angina may decrease, potentially improving patients' quality of life by enabling them to engage in daily physical activities that would otherwise cause pain. XC001 is designed to avoid toxicity issues observed with other gene therapies through a strategy of one-time, local administration and delivery through an adenoviral vector. This approach allows XC001 to achieve higher gene expression in the heart while minimizing systemic vector circulation and associated side effects. About Extroducer® Infusion Catheter System The Extroducer® Infusion Catheter System is a first-in-class endovascular delivery device which enables direct-to-tissue drug delivery. The Extroducer® addresses a significant unmet need in the field of novel therapies, enabling targeted delivery of a wide range of treatment modalities to otherwise hard to reach tumors and organs. Using standard fluoroscopy equipment and routine interventional radiology approaches, the Extroducer provides access to hard-to-reach tissues by safely penetrating the vessel wall and delivering payload directly to the target location, or inside the heart ventricle. Smartwise received U.S. Food and Drug Administration (FDA) clearance under 510(k) for the Extroducer® delivery catheter in June 2022. In 2024, XyloCor entered into a licensing agreement with SmartWise, a unit of SmartCella, to deliver XC001 via the Extroducer® Infusion Catheter System. About Chronic Refractory Angina In the United States, coronary artery disease is a leading cause of death and disability. Chronic angina pectoris occurs when the heart muscle does not receive sufficient oxygen, resulting in chest pain. This is usually due to atherosclerotic plaques that block the coronary arteries. Refractory angina is a growing problem that occurs in patients with chronic angina who are symptomatic despite optimal medical therapy and are no longer eligible for mechanical interventions like percutaneous coronary intervention (PCI) and coronary artery bypass gracing (CABG). These patients currently have no treatment options and are frequently highly symptomatic, which severely impacts their quality of life, and may exacerbate comorbidities and cause further deterioration of their health status. Refractory angina results in significant consumption of healthcare resources, including visits to the emergency department as a result of patients' chest pain. About XyloCor XyloCor Therapeutics, Inc. is a private, clinical-stage biopharmaceutical company developing potential best-in-class gene therapies to transform outcomes for patients with cardiovascular disease. The Company's lead product candidate, XC001, is in clinical development for use in patients with coronary artery disease and refractory angina for whom there are no treatment options. XyloCor has a second preclinical investigational product, XC002, in the discovery stage, being developed for the treatment of patients with cardiac tissue damage from heart attacks. The company, which was co‑founded by Ronald Crystal, MD, and Todd Rosengart, MD, has an exclusive license from Cornell University. For more information, visit About SmartCella SmartCella, founded in 2014, is a global biotech company pioneering the future of targeted therapies through delivery solutions and advanced therapy development. SmartCella combines novel delivery platforms, such as the Extroducer® (an endovascular delivery device that enables direct injection to hard-to-reach organs and tumors), with cutting-edge development and manufacturing of cell therapies. For more information, visit
Business Wire
07-07-2025
- Health
- Business Wire
CorFlow Therapeutics宣布MOCA-II IDE關鍵性試驗獲得FDA核准，旨在驗證新型心臟病發作治療技術
瑞士巴爾--(BUSINESS WIRE)--(美國商業資訊)-- 專注於微血管疾病的心臟護理領域先驅企業 CorFlow Therapeutics AG (CorFlow) 今日宣布，該公司的技術已獲得美國食品藥物管理局(FDA)的研究性器材豁免(IDE)核准，這表示關鍵性臨床試驗可在美國各醫院啟動。CorFlow目前正準備為這些臨床試驗中心配備CorFlow系統，展開相關培訓，並開始招募接受心臟病治療的病患。 這項名為MOCA-II的IDE關鍵性試驗旨在前瞻性驗證專有CorFlow CoFl系統在原發性經皮冠狀動脈介入治療(PCI)過程中診斷微血管阻塞(MVO)存在與否的準確性。主要終點是將CoFI診斷結果與心臟磁振造影(MRI)掃描的診斷參考標準進行對比。該試驗已獲准在美國和歐洲的知名研究機構招募200多名ST段上升型心肌梗塞(STEMI)病患。 在2024年成功完成MOCA-I首次人體試驗後，MOCA-II研究成為將這一獨特技術推向全球介入心臟病學家的關鍵一步，協助其快速診斷心臟病發作病患的MVO問題。這進而可望為大量MVO病患帶來新的治療方法和護理路徑——目前這類病患的臨床不良結局發生率較高。CorFlow技術不僅旨在診斷MVO，還能做為局部藥物遞送系統，用於輸送診斷劑和治療劑，相關研究正在獨立進行中。 美國政府疾病控制與預防中心的資料顯示，美國每30秒就有一人突發心臟病，每年報告病例約80萬例。歐洲的發病率和患病率也處於類似高位。超過一半的STEMI心臟病發作病患被證實存在MVO，且既往研究顯示，MVO的存在是導致不良事件的主要因素。目前，在歐美地區，尚無獲准可在急性冠狀動脈介入治療期間診斷MVO的技術，也沒有專門針對MVO的獲准治療器材。心臟病發作及相關心臟疾病仍是全球導致死亡和身心障礙的主要原因之一。 CorFlow執行長Paul Mead表示：「介入心臟病學和心臟病發作護理領域的突破可追溯至100多年前，這是醫療護理進步的重大成功案例之一，但該領域的先驅和傑出人士都認同，這項工作尚未完成。大多數急性STEMI倖存者存在MVO問題，而目前這些病患的預後差得驚人。我們旨在揭露這一問題，並證明人們能夠為此採取行動。這一里程碑讓我們向兌現改善這些病患護理的承諾又邁進了一步——我們深知在這方面我們能做得更好。」 MOCA-II試驗由心臟病發作護理領域的世界知名專家主導，分別是美國俄亥俄州辛辛那提市基督醫院的Timothy Henry博士，以及瑞士盧加諾市提契諾心臟中心研究所的Marco Valgimigli教授。兩人在心血管研究領域共發表了超過1000篇經同儕審查的論文。 Tim Henry博士表示：「身為一名從事STEMI病患治療和研究數十年的介入心臟病學家，我對這項關鍵性試驗的啟動感到振奮不已——相關技術可望對病患的預後產生重大影響。我堅信，在原發性PCI過程中，在護理現場高度確信哪些病患存在MVO，能立即改變我們對病患的治療方式。」Valgimigli教授補充說道：「我是MOCA-I首次人體試驗的重要參與者，如今看到第二代技術可用於關鍵性試驗，我感到非常激動，並期待能進一步協助對MVO的即時科學理解。儘管醫學界對於如何治療這類病患存在不同觀點，但毫無疑問，準確診斷是我們需要邁出的第一步。我樂觀地認為，CorFlow技術獲准供同行介入心臟病學家日常使用後，將有助於推動該領域的發展。」 關於CorFlow Therapeutics：公司總部位於瑞士巴爾，在義大利和美國設有子公司。CorFlow由國際創投公司共同投資，最近一輪融資是2024年9月宣布的B輪融資。CorFlow立志成為診斷和治療解決方案領域的領導者，以恢復存在關鍵需求的人體任何部位的健康微血管血流。在瑞士創新署(Innosuisse)的資助下，CorFlow與伯恩大學、蘇黎世聯邦理工學院和蘇黎世大學醫院的科學家密切合作，持續探索這項獨特專利技術的應用場景。 免責聲明：本公告之原文版本乃官方授權版本。譯文僅供方便瞭解之用，煩請參照原文，原文版本乃唯一具法律效力之版本。
