Dynavax Initiates Phase 3 Study of HEPLISAV-B(TM)
April 15 2014 - 6:00AM
Marketwired
Dynavax Initiates Phase 3 Study of HEPLISAV-B(TM)
BERKELEY, CA--(Marketwired - Apr 15, 2014) - Dynavax
Technologies Corporation (NASDAQ: DVAX) today announced initiation
of a new phase 3 clinical trial of HEPLISAV-B, its investigational
adult hepatitis B vaccine. This large safety and immunogenicity
study (known as HBV-23) was designed to address the Complete
Response Letter regarding the HEPLISAV-B Biologics License
Application that was issued to Dynavax by the U.S. Food and Drug
Administration in February, 2013.
HBV-23 will provide greater clarity regarding the safety profile
of HEPLISAV-B by significantly expanding the overall database of
vaccinated subjects. The study will also assess the immunogenicity
of HEPLISAV-B in subjects for whom approved hepatitis B vaccines
are less effective. Dynavax expects that all study subjects will be
enrolled by the end of 2014 and all follow-up will be completed by
the fourth quarter of 2015.
HBV-23 Study Design
HBV-23 is an observer-blinded, randomized, active-controlled,
trial being conducted at approximately 40 sites in the U.S.
Approximately 8,250 adult subjects between the ages of 18 and 70
will be randomized in a 2:1 ratio to receive a 2-dose series of
HEPLISAV-B or a 3-dose series of a control vaccine, Engerix-B®.
Enrollment will be stratified by site, age group and type 2
diabetes mellitus status. Safety follow-up will continue for all
subjects through study week 56.
The co-primary objectives of HBV-23 are to:
- Evaluate the overall safety of HEPLISAV-B with respect to
clinically significant adverse events (AEs), and
- Demonstrate the noninferiority of the seroprotection rate
induced by HEPLISAV-B compared with Engerix-B at Week 28 in
subjects with type 2 diabetes mellitus.
The study also includes multiple secondary objectives intended
to further elucidate the safety profile of HEPLISAV-B with respect
to specific outcomes and to assess its immunogenicity in
subpopulations including smokers, men, individuals with higher body
mass, and those aged 40 years and older.
All AEs from HBV-23 that are considered to represent potential
autoimmune disorders will be reviewed by an independent Safety
Evaluation and Adjudication Committee (SEAC). The SEAC will provide
an opinion whether each event is autoimmune in origin, pre-existing
or new-onset, and related or not related to study treatment. The
full safety dataset will be reviewed periodically by an independent
Data and Safety Monitoring Board (DSMB) to ensure the safety of
subjects and scientific integrity of the study. The DSMB will
perform at least three prespecified reviews.
Additional details regarding HBV-23 are available at
www.clinicaltrials.gov.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that
combines hepatitis B surface antigen with a proprietary Toll-like
Receptor 9 agonist to enhance the immune response. Dynavax has
worldwide commercial rights to HEPLISAV-B.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, discovers
and develops novel vaccines and therapeutics in the areas of
infectious and inflammatory diseases and oncology. Dynavax's lead
product candidate is HEPLISAV-B, a Phase 3 investigational adult
hepatitis B vaccine. For more information visit
www.dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking" statements,
including expectations for the conduct, timing and sufficiency of
an additional clinical trial for HEPLISAV-B. Actual results may
differ materially from those set forth in this press release due to
the risks and uncertainties inherent in our business, including
whether successful clinical and regulatory development and review
and approval of HEPLISAV-B and our process for its manufacture can
occur without significant delay or additional studies; whether our
studies and manufacturing efforts are sufficient to support
registration for commercialization of HEPLISAV-B in either or both
of the US and Europe; the timing for and costs of achieving the
size of the safety database; the results of clinical trials and the
impact of those results on the initiation and completion of
subsequent trials and issues arising in the regulatory process,
including whether a US or European licensure application will be
approved; our ability to obtain additional financing to support the
development and commercialization of HEPLISAV-B and our other
operations; possible claims against us, including enjoining sales
of HEPLISAV-B, based on the patent rights of others; and other
risks detailed in the "Risk Factors" section of our current
periodic reports with the SEC. We undertake no obligation to revise
or update information herein to reflect events or circumstances in
the future, even if new information becomes available. Information
on Dynavax's website at www.dynavax.com is not incorporated by
reference in our current periodic reports with the SEC.
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