NEW YORK – The Cardiovascular Disease National Collaborative Enterprise (CADENCE), a clinical translational research program in Singapore, and the biotechnology company Medera on Tuesday launched a multi-center trial to test the ability of Medera's investigational gene therapy, SRD-001, in treating heart failure.
CADENCE, an organization supported by the Singapore Ministry of Health, aims to advance cardiovascular disease research by bringing together the latest technologies and capabilities in the country. The latest heart failure gene therapy trial will be the first time Singapore's two national heart centers, the National Heart Centre Singapore and the National University Heart Centre Singapore, will collaborate.
The Phase I/IIa trial will enroll heart failure patients with reduced ejection fraction and gauge SRD-001's ability to improve the heart's ability to pump blood, reduce symptoms and signs of heart failure, and keep patients out of the hospital. SRD-001, developed by Medera subsidiary Sardocor, uses an adeno-associated virus to deliver an engineered version of the SERCA2a gene directly to the cardiac ventricular muscle cells via Sardocor's intracoronary infusion system.
"Sardocor's unique regulated intracoronary delivery methodology is a minimally invasive procedure that targets the heart directly, designed to minimize drug dosage, and therefore side effects, while preserving efficacy," Medera President and Cofounder Roger Hajjar said in a statement. "While the Singapore trial's initial focus is on congestive heart failure, this foundation will enable subsequent expansion to other cardiac indications."
The US Food and Drug Administration has cleared an investigational new drug application on SRD-001, allowing Medera to begin testing the gene therapy in clinical trials. In Singapore, the multi-center study will be conducted at Tan Tock Seng Hospital, which is the only study site outside of the US. CADENCE highlighted that this is the first gene therapy trial for heart failure to take place in Asia. Researchers expect to complete enrollment in the trial, report the first data, and advance SRD-001 to a Phase IIb portion next year.