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Reports Phase 1B Safety and Immunogenicity Results for Hepatitis
B Therapy Candidate
CA -- December 23, 2010 -- Dynavax Technologies Corporation
(NASDAQ: DVAX) today reported safety and immunogenicity
data from its Phase 1b clinical trial of DV-601, its proprietary
hepatitis B therapeutic vaccine. The dose escalation study
assessed safety and the immunologic and virologic responses
in 14 subjects with chronic hepatitis B infection. The Phase
1b data showed:
doses were generally safe and well tolerated; and
immunologic and virologic responses were observed
across cohorts at all dose levels.
conclusions regarding the potential clinical impact of the
therapy could be reached in this small study. Dynavax's
treatment approach combines both the surface and core hepatitis
B virus (HBV) antigens with Iscomatrix adjuvant originally
entered into development by Rhein Biotech prior to its acquisition
by Dynavax in 2006. The candidate vaccine, DV-601, is designed
to induce an immune response against HBV-infected cells
and if proven to be safe and effective, may offer an alternative
therapeutic option for patients chronically infected with
Technologies Corporation, a clinical-stage biopharmaceutical
company, discovers and develops novel products to prevent
and treat infectious diseases. The company's lead product
candidate is Heplisav, a Phase 3 investigational adult hepatitis
B vaccine designed to enhance protection more rapidly and
with fewer doses than current licensed vaccines. For more
information, visit www.dynavax.com.
Technologies. Dynavax Reports Phase 1B Safety and Immunogenicity
Results for Hepatitis B Therapy Candidate. Press release.
December 23, 2010.