FDA Grants Vical Orphan Drug Designation for VL-2397 for the Treatment of Invasive Aspergillosis
January 06 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 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,” said Mammen 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.
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
the potential benefits of VL-2397 and orphan drug 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 orphan drug
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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