Vical and Mycoses Study Group Education and Research Consortium Establish Collaboration to Advance Vical’s Novel Antifungal...
February 01 2018 - 6:30AM
Vical Incorporated (Nasdaq:VICL) and the Mycoses Study Group
Education and Research Consortium (MSGERC) today announced the
establishment of a collaboration to advance Vical’s novel
antifungal drug product candidate for the treatment of invasive
aspergillosis. This collaboration will combine the clinical
development expertise of Vical with the specialized expertise of
the MSGERC in the area of invasive fungal infections.
“We are excited to establish this collaboration
with the world’s leading mycology clinicians and thought leaders,”
said Dr. Mammen “Anza” Mammen, Vical’s Senior Vice President,
Clinical Development. “We believe the MSGERC will add substantial
value to our VL-2397 antifungal program by serving as advisors to
our Phase 2 trial and helping provide exposure for the study among
their member clinicians who may be interested in taking part as
investigators.”
The U.S. Food and Drug Administration (FDA) has
advised that 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 established under the 21st Century Cures Act of 2016. Vical
plans to initiate a single Phase 2 trial for the treatment of
invasive aspergillosis in acute leukemia patients
and allogeneic hematopoietic cell transplant (HCT) recipients
in the first quarter of 2018.
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 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.
About MSGERCThe Mycoses Study
Group Education & Research Consortium is a non-profit
organization dedicated to providing continuing medical education
and scientific/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.
This organization will also serve as a resource and support for
patients and caregivers who are affected by these serious rare
diseases. This group’s mission includes setting the annual
educational and research agendas for mycology and providing
top-quality continuing education initiatives to MSG-member
institutions and to other institutions and practitioners throughout
the United States and globally.
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, and
expected benefits of the collaboration between Vical and MSGERC.
Risks and uncertainties include whether Vical or others will
continue development of VL-2397; the risk that the
collaboration between Vical and MSGERC is terminated earlier than
expected or does not result in expected benefits to the 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)
646-1127Website: www.vical.com
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