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).
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