Vical Initiates Phase 1 Trial of Novel Antifungal Compound VL-2397
March 09 2016 - 07:46PM
Vical Incorporated (Nasdaq:VICL) today announced the initiation of
a Phase 1 clinical trial of the company’s novel antifungal,
VL-2397. 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.
VL-2397 represents a potential new class of
antifungal compound to address invasive aspergillosis, which causes
significant morbidity and mortality in immunocompromised patients,
including transplant recipients. In preclinical studies to date, it
has demonstrated faster antifungal activity than marketed drugs and
activity against azole-resistant fungal pathogens. Current
treatment options have limited efficacy, as approximately 50-60% of
allogeneic hematopoietic stem cell transplant recipients with
invasive aspergillosis infections die within 12 weeks. Over the
past 30 years, only one new class of antifungal drugs
(echinocandins) has been introduced.
“The initiation of this trial represents an
important milestone for Vical by expanding our infectious disease
pipeline outside the area of vaccines,” said Vijay Samant, Vical’s
Chief Executive Officer. “We are pleased that our team was able to
design and initiate this trial so quickly after licensing this
compound from Astellas.”
The U.S. Food and Drug Administration (FDA)
recently granted Vical orphan drug and qualified infectious disease
designation (QIDP) for VL-2397 for the treatment of invasive
aspergillosis.
Vical intends to develop VL-2397 as a treatment
for invasive aspergillosis and for infections caused by other
pathogenic fungi, which may represent a meaningful commercial
opportunity within the $4 billion global market for systemic
antifungals.
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, 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 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
ir@vical.com
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