SAN DIEGO, Aug. 19, 2015 (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 a qualified infectious disease product (QIDP) designation to Vical's investigational antifungal product candidate, VL-2397. The QIDP designation is for the treatment of invasive aspergillosis.
The QIDP designation was created by the Generating Antibiotic Incentives Now (GAIN) Act of 2012. It provides certain incentives for the development of new anti-infectives, including eligibility for priority review, the FDA's Fast Track program, and a five-year extension of exclusivity under the Hatch-Waxman Act.
"The high mortality rate and emerging drug resistance call for new therapeutic options for the treatment of invasive fungal infections. It is exciting to see an antifungal with a novel mechanism of action and with rapid fungicidal activity in preclinical models. There is an urgent need for new fungicidal drugs in the clinics," said John R. Perfect, M.D., Chief of Division of Infectious Diseases at Duke University Medical Center.
VL-2397, also known as ASP2397, 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 the ICU. In preclinical studies to date, VL-2397 has demonstrated 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.
"We are pleased that the FDA has granted QIDP designation to VL-2397 for the treatment of invasive aspergillosis," said Igor P. Bilinsky, Ph.D., Vical's Senior Vice President of Corporate Development. "We are excited by the potential of VL-2397 to save lives of patients with systemic fungal infections, and the QIDP designation may enable us to expedite development of this novel antifungal. We plan to file an investigational new drug application (IND) and initiate a Phase 1 clinical trial for VL-2397 in the first half of 2016."
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.
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 the potential benefits of VL-2397 and QIDP designation, Vical's capabilities to develop VL-2397 and Vical's development plans and timelines for VL-2397. Risks and uncertainties include whether Vical or others will continue development of VL-2397; whether planned clinical development of VL-2397 will begin when expected, or at all; whether the results of future preclinical or 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 QIDP 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