FDA Grants Vical Fast Track Designation for VL-2397 for the Treatment of Invasive Aspergillosis
March 30 2016 - 6:30AM
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-2397VL-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 VicalVical 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 StatementsThis
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
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