Chronic Angina Therapy Gets Fast Track Designation From FDA
XC001 is a novel gene therapy intended to promote angiogenesis.
The US Food and Drug Administration (FDA) has granted Fast Track designation to XyloCor's XC001, a one-time treatment investigated as a means to improve exercise tolerance in patients with chronic angina who are not amenable to coronary artery bypass surgery, percutaneous coronary intervention, or stents.
FDA Fast Track designation will speed the development and review process of the drug, according to a press release.
XC001 is a novel gene therapy intended to promote angiogenesis — the formation of new vessels that will provide increased arterial blood flow to regions of the heart with inadequate blood supply. Increased blood flow would relieve myocardial ischemia, improve ventricular performance, and alleviate angina symptoms as well as disability from the condition.
"There are many patients in the United States with refractory angina and there are no available treatment options," E. Magnus Ohman, MBBS, professor of medicine and director of the Duke Program for Advanced Coronary Disease at Duke University in Durham, North Carolina, said in a press release. "These patients have significant limitations in terms of their daily activities because of the chest pain associated with their ischemic disease. XC001 could be an important new option for them."
FDA grants fast track designation to XyloCor Therapeutics lead candidate XC001 [news release]. Newton Square, PA: XlyoCor Therapeutics; 2017. http://xylocor.com/xylocor-therapeutics/news/. Published May 8, 2017. Accessed Mary 16, 2017.