FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

XyloCor Therapeutics Wins Fast Track Designation For XC001

May 11, 2017

The FDA granted a Fast Track designation to XyloCor Therapeutics’ lead product candidate XC001 (AdVEGF-All6A+), a cardiovascular angiogenic gene therapy.

XC001 is a one-time treatment being investigated for improving exercise tolerance in patients with chronic angina that is not amenable to conventional revascularization procedures such as coronary artery bypass surgery and percutaneous coronary intervention and stents.

XC001 promotes angiogenesis, the formation of new vessels that can provide arterial blood flow to myocardial regions with inadequate blood supply. The gene therapy is intended to relieve myocardial ischemia, increase left ventricular performance, alleviate pain symptoms and disability, and potentially improve prognosis.

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