Vical Announces that its Antifungal VL-2397 is Eligible for Limited Use Indication Approval by FDA Based on a Single Phase 2 ...
October 02 2017 - 3:15PM
Vical plans to initiate Phase 2 trial of VL-2397
for the treatment of invasive aspergillosis in 4Q 2017
Vical Incorporated (Nasdaq:VICL) today announced that the U.S. Food
and Drug Administration (FDA) has advised that Vical’s
investigational antifungal VL‑2397 would be eligible for a Limited
Use Indication (LUI) approval 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 (LPP) established under the 21st Century Cures Act of 2016.
Vical plans to initiate a single Phase 2 trial for the treatment of
invasive aspergillosis (IA) in acute leukemia patients
and allogeneic hematopoietic cell transplant (HCT) recipients
in the fourth quarter of 2017.
“The LPP will allow Vical to develop and
commercialize VL-2397 on a potentially accelerated basis for a
limited use indication,” said Vijay Samant, Vical’s President and
CEO. “New antifungals with novel mechanisms of action are needed to
address the urgent need in IA, particularly in patients who are
intolerant to existing drugs and in patients infected by
azole-resistant strains.”
Dr. Haran Schlamm, MD, Vical’s infectious
disease consultant and former Pfizer Senior Medical Director
responsible for Pfizer’s antifungal portfolio also commented, “The
preclinical and clinical data to date for VL-2397 supports the
profile of an ideal antifungal agent which must be fast acting,
have minimal drug interactions, and a low risk for toxicity.”
The global Phase 2 trial will be a
non-inferiority study comparing VL-2397 to standard of care
treatment for IA. Approximately 200 acute leukemia patients and
recipients of allogeneic HCT will be enrolled and randomized 2:1.
The primary endpoint will be all-cause mortality (ACM) at 4 weeks
with a key secondary endpoint of ACM at 6 weeks. Achieving LUI
approval is contingent upon successfully meeting both
endpoints.
In addition to interactions with the FDA, Vical
has worked extensively with the Mycoses Study Group Education and
Research Consortium (MSGERC) on the Phase 2 study design and
preparations. MSGERC provides scientific and medical thought
leadership for evidence-based medicine in the diagnoses,
prevention, treatment and maintenance of patients at risk for or
afflicted with invasive fungal infections.
Vical will conduct a conference call and webcast
tomorrow, October 3, at noon Eastern Time, to discuss this
announcement. The call and webcast are open on a listen-only basis
to any interested parties. To listen to the conference call, dial
in approximately ten minutes before the scheduled call to
(913)312-1496 (preferred), or (888)417-2254 (toll-free), and
reference confirmation code 9759530. A replay of the call will be
available for 48 hours beginning about two hours after the call. To
listen to the replay, dial (719)457-0820 (preferred) or
(888)203-1112 (toll-free) and enter replay passcode 9759530. The
webcast will also be available live and archived through the events
page at www.vical.com. For further information, contact Vical’s
Investor Relations department by phone at (858)646-1127 or by
e-mail at ir@vical.com.
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 IA in a broader population.
About VL-2397VL-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
AspergillosisInvasive 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 IA are diagnosed annually worldwide.
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
anticipated developments in clinical programs, including the plans,
timing of initiation, and enrollment for clinical trials. 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 planned
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 any product candidates will be shown to be safe and
efficacious in clinical trials; the fact that results from the
planned 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) 646-1127
Website: www.vical.com
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