FDA Grants Vical Orphan Drug Designation for VL-2397 for the Treatment of Invasive Aspergillosis

FDA Grants Vical Orphan Drug Designation for VL-2397 for the Treatment of Invasive Aspergillosis


SAN DIEGO, Jan. 06, 2016 (GLOBE NEWSWIRE) -- Vical Incorporated (Nasdaq:VICL), a biotechnology company developing vaccines and therapeutics for prevention and treatment of infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has grantedVical orphan drug designation for its investigational antifungal product candidate, VL-2397 for the treatment of invasive aspergillosis. VL-2397 is also known as ASP2397 and Cyclo{-Asn-Leu-d-Phe-Al[(N5-acetyl-N5-hydroxy-Orn)-(N5-acetyl-N5-hydroxy-Orn)-(N5-hydroxy-Orn)]-} . Al(III).  Orphan drug designation provides several benefits to Vical, including a seven-year period of market exclusivity in the United States.

“We are pleased that the FDA has granted Vical orphan drug designation to develop VL-2397 for the treatment of invasive aspergillosis,” saidMammen P. Mammen, Jr., M.D., Vical’s Vice President of Clinical Vaccines. “This is in addition to the qualified infectious disease product (QIDP) designation that FDA granted Vical for VL-2397 for the treatment of invasive aspergillosis in August 2015.  We are excited by the potential for VL-2397 to save lives of patients with systemic fungal infections such as aspergillosis. We plan to initiate a Phase 1 clinical trial in the first half of 2016.”

VL-2397 is part of a potential new class of antifungal compounds for the treatment of systemic fungal infections. Systemic fungal infections are major causes of morbidity and mortality in immunocompromised patients, such as transplant recipients, in patients undergoing chemotherapy and in patients in intensive care units. In preclinical studies to date, VL-2397 has demonstrated both faster fungicidal activity than marketed drugs and activity against azole-resistant fungal pathogens. VL-2397 was initially developed by Astellas Pharma Inc. (TOKYO: 4503). In March 2015, Astellas granted Vical an exclusive worldwide license to develop and commercialize VL-2397.

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Wednesday, January 6, 2016
New antifungal drugs