KING OF PRUSSIA, PA — XyloCor Therapeutics has dosed the first patient in its Phase 2b EXACT-2 trial evaluating XC001 (encoberminogene rezmadenovec), a novel gene therapy designed to help patients with coronary artery disease and refractory angina who have exhausted other treatment options.
XC001 uses an adenoviral vector to deliver vascular endothelial growth factor (VEGF) directly into the heart muscle via a one-time, catheter-based procedure. By stimulating new blood vessel growth, the therapy aims to reduce cardiac ischemia and chest pain, ultimately helping patients improve their ability to perform daily activities.
“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.
EXACT-2 is a global, multicenter, randomized, double-blind study that will enroll 100 patients. The therapy is delivered using the Extroducer® Infusion Catheter System, a specialized device that injects the gene therapy directly into the heart in a straightforward cardiac catheterization procedure — avoiding the need for surgery used in earlier studies.
Dr. Timothy Henry at The Christ Hospital Health Network in Cincinnati, Ohio, administered the first dose. Henry praised the new delivery approach, noting that it “maintains the accuracy of delivery of XC001 to the heart and improves the safety over the surgical administration approach used in EXACT-1.”
The earlier EXACT-1 Phase 1/2 trial demonstrated promising results. Patients treated with XC001 saw significant improvements in exercise capacity and reductions in angina frequency, along with measurable decreases in ischemic burden as detected by PET imaging. Notably, while 93% of participants started the study with severe chest pain that limited daily activities, 43% reported no chest pain during normal activities after six months. XC001 was also well tolerated, with no serious drug-related adverse events reported.
Beyond refractory angina, XyloCor plans to launch an additional Phase 2 trial later this year evaluating XC001 as an adjunct therapy during coronary artery bypass graft surgery (CABG).
With these advances, XyloCor aims to offer a transformative treatment option to patients who currently face limited choices and a significantly reduced quality of life.
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