Pentixapharm has secured clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application covering its CXCR4-targeted PET/CT imaging agent gallium-68 (Ga-68) pentixafor.
With the clearance, the Berlin-based company will launch a U.S. multicenter phase III study called PANDA to evaluate the agent in patients with treatment-resistant hypertension with underlying primary aldosteronism. Ga-68 pentixafor targets chemokine receptor CXCR4, which is overexpressed by inflammatory cells in various conditions and diseases, and shows promise distinguishing unilateral from bilateral disease in primary aldosteronism, Pentixapharm noted.
Primary aldosteronism is a common cause of hypertension, and distinguishing unilateral from bilateral disease determines whether surgery or lifelong medication is appropriate for patients, the company added.
