WAYNE, PA, and TULLINGE, Sweden — XyloCor Therapeutics, Inc. has signed a licensing agreement with SmartWise to use the Extroducer Infusion Catheter System. This endovascular device is designed to deliver advanced therapies directly into the heart. XyloCor intends to use the Extroducer to support the delivery of its leading gene therapy candidate, XC001, in future clinical studies and commercial applications.
Al Gianchetti, President and CEO of XyloCor, said the partnership will enhance the safety and ease of delivering XC001 without surgery. “Teaming up with SmartCella will help in our effort to optimize patient safety and tolerability while maintaining accurate delivery of XC001 to target areas in the heart for patients with refractory angina,” he said. The collaboration also provides the potential to treat coronary artery disease at earlier stages, benefiting a larger patient group.
XC001 aims to reduce ischemic burden by creating new blood vessels in the heart through the local expression of vascular endothelial growth factor (VEGF). The Extroducer catheter offers a less invasive method for delivering XC001 directly to the heart, reducing risks associated with surgical administration.
Dr. Timothy D. Henry, Interventional Cardiologist and Director of the Lindner Center at The Christ Hospital in Cincinnati, praised the new delivery method. “We welcome the Extroducer delivery of XC001 as it offers a more efficient method for gene therapy administration for patients with refractory angina,” he said.
The EXACT Phase 1/2 trial recently assessed XC001 for treating refractory angina, a chronic condition affecting over a million people in the U.S. In this trial, 42 patients received XC001 through minimally invasive surgery. Results showed that XC001 could be safely administered and led to significant improvements in exercise duration and angina frequency. Six months post-treatment, 43% of patients reported no chest pain with ordinary activities, and 58% had no angina episodes after 12 months. There were no serious adverse events related to the drug.
Looking ahead, the Phase 2b trial will be a randomized double-blind study evaluating the safety and efficacy of XC001 administered via the Extroducer Delivery Catheter in patients with refractory angina due to coronary artery disease.
Under the terms of the agreement, XyloCor gains global rights to use the Extroducer for administering XC001. SmartCella will supply the catheters for clinical trials and commercial use. The deal includes an upfront payment, milestone payments, and a royalty on sales, with the total value estimated at approximately $130 million.
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