Vical Announces Joint Development Program With AnGes on a Treatment for Chronic Hepatitis B Infection
October 24 2017 - 6:30AM
Vical Incorporated (Nasdaq:VICL) announced today that it is
pursuing early stage development of a novel treatment for chronic
hepatitis B virus (CHB) infection based on its DNA and
lipid-delivery technologies. This development effort is being
conducted in collaboration with Vical’s strategic partner, AnGes,
Inc of Osaka, Japan. The initial stage of this program will be to
demonstrate preclinical proof of concept for inhibiting HBV
infection in a human liver model in the second half of 2018. The
ultimate aim of this program would be to demonstrate eradication of
persistent HBV infection in CHB patients.
AnGes has provided partial funding for the
initial stage of this program and, if successful, Vical expects
that AnGes will continue to participate in the funding of the
program. AnGes has been granted the right of first refusal to
negotiate with Vical for an exclusive license to develop and
commercialize this therapy in Japan.
Vical intends to first establish in vitro proof
of concept against HBV infection using an HBV-producing cell line
followed by in vivo testing in an elaborate preclinical model of
HBV infection which enables human hepatocytes to be infected with
HBV and then treated and monitored for suppression of several
virologic markers including reduction in covalently-closed circular
(ccc) DNA levels in the livers. Should Vical establish in vivo
proof of concept, it intends to advance the product towards Phase 1
testing, ideally in CHB patients, to achieve clinical proof of
concept at an early stage of development. Results of the
preclinical proof of concept studies are anticipated in the second
half of 2018.
About chronic HBV
infectionChronic HBV infection affects nearly 250 million
people worldwide and an estimated 786,000 deaths are attributed
annually to CHB infection worldwide. People with CHB infection are
at increased risk for severe liver disease, with 15% to 40%
developing cirrhosis or hepatocellular carcinoma. Although
currently-available antiviral drugs effectively inhibit the HBV
reverse transcriptase and suppress viral replication while the
drugs are taken, they typically lead to only a 1% to 3% per year
cure rate. The persistence of cccDNA in infected liver cells is not
altered by the antiviral drugs so novel treatments are necessary to
eliminate this reservoir and produce a long term cure, thereby
reducing the need for lifelong antiviral drug use. Vical’s approach
is intended to address the underlying cause of persistent HBV
infection – cccDNA– by targeting hepatocytes and using molecular
interventions to inactivate the cccDNA harbored within hepatocyte
nuclei.
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 a novel HBV
therapeutic, the timeliness of completing preclinical studies and
potentially advancing a lead candidate to Phase 1 clinical testing
and Vical’s plans with respect to developing the HBV program. Risks
and uncertainties include whether Vical's technology will be
successfully applied, the risk that Vical’s and AnGes’ strategic
partnership may be terminated early, risks associated with
development of novel therapeutic programs, 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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