Contact Information: Contact: Michael Ostrach Vice President and Chief Business Officer 510-665-7257
Dynavax Completes Enrollment of First Cohort of Patients in Phase 1b Clinical Trial for Hepatitis B Therapy
| Source: Dynavax Technologies
BERKELEY, CA--(Marketwire - November 19, 2009) - Dynavax Technologies Corporation (NASDAQ : DVAX ) announced today that enrollment has been completed for the first of
three cohorts of patients receiving DV-601 hepatitis B therapy in a Phase
1b clinical trial. The safety profile of patients in the first cohort met
pre-specified criteria for dose escalation and the second cohort has been
opened for enrollment. Dynavax expects to report top-line data from this
trial in the second half of 2010. DV-601 is the first hepatitis B therapy
to combine both the surface and core HBV antigens, and Dynavax has retained
all commercial rights to this product.
About the Phase 1b Hepatitis B Therapy Trial
In this open-label, dose-escalating Phase 1b trial being conducted in
Europe, up to 30 patients will receive 6 injections of DV-601 over a three
month period. The primary endpoints of this trial are safety and
tolerability of DV-601. The secondary endpoints are immunologic and
virologic measures of efficacy.
About HBV
Over 350 million individuals worldwide are chronically infected with the
hepatitis B virus (HBV), which can lead to cirrhosis of the liver and liver
cancer. The current worldwide market for HBV therapeutics is estimated to
be over $1 billion annually and available therapies have modest efficacy.
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 HEPLISAVTM, a
Phase 3 investigational adult hepatitis B vaccine designed to provide more
rapid and increased protection with fewer doses than current licensed
vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject
to a number of risks and uncertainties, including when clinical trial data
for DV-601 may be available. 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 planned clinical trials for
DV-601 can be timely completed; 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 of DV-601 and its
other operations; 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.