Vical Initiates Phase 2 Trial of VL-2397 Antifungal for Invasive Aspergillosis
February 20 2018 - 6:00AM
Vical Incorporated (Nasdaq:VICL) announced today the initiation of
a Phase 2 trial of the Company’s VL-2397 novel antifungal compound.
The multicenter, open label randomized clinical study, will compare
the efficacy and safety of VL-2397 to standard treatment for
invasive aspergillosis in acute leukemia patients
and recipients of allogeneic hematopoietic cell transplant
(HCT).
The U.S. Food and Drug Administration (FDA) has
advised that VL‑2397 would be eligible for a Limited Use Indication
(LUI) assuming a successful outcome of a single Phase 2 trial
carried out in accordance with a protocol and statistical analysis
plan consistent with the Agency's advice. The final determination
whether the drug is approvable will be made by FDA after review of
all relevant data. The LUI is a provision of the Limited Population
Pathway established under the 21st Century Cures Act of 2016.
“The Limited Population Pathway enables Vical to
develop and potentially commercialize VL-2397 on an accelerated
basis for a Limited Use Indication, and we are pleased that the
Phase 2 trial is now underway,” said Vijay Samant, Vical’s
President and CEO. “New antifungals, especially with novel
mechanisms of action, are desperately needed to enhance treatments
options when currently marketed therapies are inadequate due to
their associated toxicities, drug-drug interactions, and the
emergence of azole-resistant strains.”
The global Phase 2 trial is expected to enroll
approximately 200 patients who will be randomized on a 2:1 basis
with approximately 134 patients treated with VL-2397 and 66
patients treated with a standard 6-week course of their physician's
choice of voriconazole, isavuconazole, or liposomal amphotericin B.
The patients in the VL-2397 arm will receive daily treatment with
VL-2397 for 4 weeks, followed by a 2-week course of physician’s
choice of the comparator. The primary endpoint of the trial is
all-cause mortality at 4 weeks and the key secondary endpoint is
all-cause mortality at 6 weeks. The trial will be conducted at
selected sites in North America, Europe and Asia.
“The preclinical and clinical data to date for
VL-2397 support the potential profile of an ideal antifungal agent
which must be fast-acting, with low risk for toxicity and drug-drug
interactions,” commented Peter Pappas, MD, Principal Investigator
of the Mycoses Study Group (MSG) and Professor of Medicine in the
Division of Infectious Diseases, Department of Medicine at the
University of Alabama in Birmingham. “The MSG has been pleased to
work with Vical in the development of this protocol, and we believe
that this compound represents a potential alternative to existing
antifungal agents to which resistance has developed, or where
significant drug-associated toxicities are encountered.”
About the Limited Population
PathwayThe LPP is designed to streamline development
programs for certain antimicrobial agents intended to treat
specific groups of patients who are not well addressed by available
therapies for their serious or life-threatening infections. Under
this pathway, the drug can be used to treat only the limited
population for which it is approved while additional trials are
conducted to establish safety and effectiveness for broader
indications. Standards for a new drug application must be met for
LUI approval. In the case of VL‑2397, the limited population
approval would be for patients for whom alternative regimens are
not available to treat their invasive aspergillosis. A Phase 3
trial would be required to support full approval of VL-2397 for the
treatment of invasive aspergillosis in a broader population.
About VL-2397
VL-2397 is Vical’s novel antifungal compound
that was licensed from Astellas Pharma in 2015. VL-2397 was
isolated from a leaf litter fungus collected in a Malaysian
national park and represents the first agent in a potentially new
class of antifungal drugs. The FDA has granted Vical Qualified
Infectious Disease Product (QIDP), Orphan Drug and Fast Track
designations for VL-2397 in the treatment of invasive
aspergillosis.
About Invasive Aspergillosis
Invasive aspergillosis is a life-threatening
infection that typically affects immunocompromised patients,
including those with acute leukemia and recipients of allogeneic
HCT or lung transplants. Infection typically starts in the lungs
and rapidly disseminates to other tissues. More than 200,000 cases
of invasive aspergillosis are diagnosed annually worldwide.
About VicalVical develops
biopharmaceutical products for the prevention and treatment of
chronic or life-threatening infectious diseases, including
antiviral and antifungal candidates in clinical development.
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
anticipated developments in clinical programs, including the
expected scope and design of the Phase 2 clinical trial of VL-2397
and the potential benefits of VL-2397. Risks and uncertainties
include whether Vical or others will continue development of
VL-2397; the risk that the FDA does not grant LUI approval of
VL-2397 following the results of Vical’s Phase 2 clinical trial;
whether Vical will be able to obtain regulatory allowances or
guidance necessary to proceed with proposed clinical trials or
implement anticipated clinical trial designs; whether on-going or
planned clinical trials will be initiated or completed on the
timelines Vical currently expects; whether VL-2397 will be shown to
be safe and efficacious in clinical trials; the fact that results
from the Phase 2 clinical trial of VL-2397 may be inconsistent with
the results from prior preclinical studies and clinical trials;
whether Vical will have access to sufficient capital to fund its
planned development activities; whether Vical will seek or gain
approval to market any product candidates; 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)
646-1127Website: www.vical.com
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