Below
is an excerpt from a press release from Dynavax describing the
recent development.
Dynavax's
Two Phase 3 Heplisav Trials Cleared
by DSMB to Continue Immunizations
Berkeley,
CA -- May 27, 2010 -- Dynavax Technologies Corporation (NASDAQ:
DVAX) today announced that the Data Safety Monitoring Board
(DSMB) established for Dynavax's two ongoing Phase 3 trials
for Heplisav has completed the second of its planned safety
assessments. The evaluation included data from 2,264 subjects
that received their first injection, 1,611 of whom received
their first and second injections. The DSMB determined that
the studies may continue without modification.
Heplisav is an innovative vaccine designed to protect against
hepatitis B infection. The DSMB reviewed safety data from two
ongoing multi-center Phase 3 trials evaluating Heplisav, one
trial in adults 40 years and older, and a second 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
U.S., Canada and Europe. 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, an 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.
6/4/10
Source
Dynavax
Technologies Corp. Dynavax's Two Phase 3 Heplisav Trials Cleared
by DSMB to Continue Immunizations. Press release. May 27, 2010.
