Curacyte, a Munich-based drug development company, and its wholly-owned US subsidiary, Apex Bioscience, have announced that the FDA has granted orphan drug designation to hemoximer for the treatment of cardiogenic shock.
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Curacyte’s hemoximer (Pyridoxalated Hemoglobin Polyoxyethylene, PHP) has been developed as a scavenger of nitric oxide, the main causative agent responsible for vasodilation and hypotension in shock. Hemoximer has been demonstrated to reverse the vasodilation and resolve the hypotension associated with distributive shock. Hemoximer has completed Phase II clinical studies in its primary indication, distributive shock and is entering a Phase III study in catecholamine-resistant distributive shock.
Helmut Giersiefen, CEO of Curacyte, said: “The FDA’s decision to grant an orphan drug designation for hemoximer as a treatment for patients suffering from cardiogenic shock encourages us in developing our lead product in its first line extension that can potentially broaden hemoximer’s clinical utility in shock.”
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