Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study
Completion
Planned Safety Assessments Complete
BERKELEY, CA, Feb 23, 2011 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) today announced that the Data Safety Monitoring Board (DSMB)
established for Dynavax's two ongoing Phase 3 trials for HEPLISAV(TM) has
completed its planned safety assessments. The DSMB determined that the studies
may continue without protocol modification, and that no other formal meetings of
the DSMB are required.
Tyler Martin, M.D., President and Chief Medical Officer, commented, "This DSMB
review is an important milestone for our Phase 3 program. All subjects in our
large safety and lot-to-lot consistency trial randomized to HEPLISAV are now
eight months past their last dose. It would be unlikely to see a serious adverse
event related to HEPLISAV at this time. Based on our progress, we look forward to
completing the trials as planned and filing our BLA by the end of 2011."
The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials
evaluating HEPLISAV, the first a lot-to-lot consistency trial in adults 40 years
and older, and the second a trial in chronic kidney disease patients. The DSMB is
comprised of an independent group of medical experts who are responsible for
reviewing and evaluating subject safety data at regular intervals during the
ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate
is being evaluated in two Phase 3 studies that are directed toward fulfilling
licensure requirements in the U.S., Canada and Europe. Enrollment has been
completed for both studies. In a completed pivotal Phase 3 trial, HEPLISAV
demonstrated increased, rapid protection with fewer doses than current licensed
vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing
the vaccine for large, high-value populations that are less responsive to current
licensed vaccines, including individuals with chronic kidney disease. HEPLISAV
combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9
agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax 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 with fewer doses
than current licensed vaccines. For more information visit
dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a
number of risks and uncertainties, including statements regarding the timing of
study completion and the BLA submission. 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 approval of HEPLISAV can occur in a timely manner or without
significant additional studies or difficulties or delays in development or
clinical trial enrollment, whether the studies can support registration for
commercialization of HEPLISAV; 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; the Company's ability to obtain additional
financing to support the development and commercialization of HEPLISAV and its
other operations, possible claims against the Company 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
dynavax.com is not incorporated by reference in the Company's current
periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact |
