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VCIL – Article
Vical Incorporated (Nasdaq: VICL) announced that the U.S. Food and Drug Administration (FDA) has granted Vical Fast Track designation for its investigational antifungal product candidate, VL-2397, for the treatment of invasive aspergillosis. The FDA’s Fast Track program is designed to expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need.
“New therapeutic options are needed to treat invasive aspergillosis, which continues to be a major source of morbidity and mortality in immunocompromised patients,” said Larry R. Smith, Ph.D., Vical’s Vice President of Vaccine Research. “The Fast Track designation for VL-2397, in addition to the qualified infectious disease product (QIDP) and the orphan drug designations already granted by the FDA, can facilitate expedited development of VL-2397. We believe VL-2397 has the potential to make a meaningful impact in the treatment of patients with systemic fungal infections such as aspergillosis.”
In preclinical studies to date, VL-2397 has demonstrated faster antifungal activity than marketed drugs and activity against azole-resistant fungal pathogens. Vical initiated a Phase 1 clinical trial of VL-2397 in March 2016. The randomized, double-blind trial will evaluate safety, tolerability and pharmacokinetics of VL-2397 at single and multiple ascending doses in healthy volunteers at a single U.S. clinical site.
Source: Street Insider
SCS LLC has not been compensated for this article.
SCS LLC was previously compensated up to twenty thousand dollars each by star media llc for the mention of INVT and XXII however those contracts have expired.