×

FDA Grants Vical Fast Track Designation for VL-2397 for the Treatment of Invasive Aspergillosis

SAN DIEGO, March 30, 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 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.

About VL-2397
VL-2397 exemplifies a 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 faster antifungal 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.

About Vical
Vical develops biopharmaceutical products for the prevention and treatment of chronic or life-threatening infectious diseases, based on its patented DNA delivery technologies and other therapeutic approaches. Additional information on Vical is available at www.vical.com.

Forward-Looking Statements
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about the potential uses and benefits of VL-2397 and Fast Track designation, the parameters and timing of the Phase 1 trial, the potential market opportunity for VL-2397 and Vical’s development plans and strategy with respect to VL-2397. Risks and uncertainties include whether Vical or others will continue development of VL-2397; whether planned clinical development of VL-2397 will continue as expected, or at all; whether the results of clinical studies will be consistent with prior preclinical studies or will otherwise merit further development; whether Vical or its collaborative partners will seek or gain approval to market any product candidates, including VL-2397; whether Vical will be able to realize any of the potential benefits of Fast Track designation for VL-2397; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.

Contact: Andrew Hopkins (858) 646-1127 Website: www.vical.com

Source:Vical Incorporated