Dynavax Initiates Proof of Mechanism Trial in Lupus Patients
Milestone Payment From GSK Earned
BERKELEY, CA, Dec 20, 2011 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) announced today the initiation of a proof-of-mechanism
clinical trial of the TLR7 and TLR9 inhibitor, DV1179, in systemic lupus
erythematosus (SLE) patients. Initiation of this trial entitles Dynavax to
receive a $6 million milestone payment from GlaxoSmithKline (GSK) under their
worldwide strategic alliance. GSK has an exclusive option to obtain a license to
the program following completion of this trial.
The first of two stages of the trial will evaluate ascending doses of DV1179 for
safety and tolerability in SLE patients, each of whom will receive eight weekly
injections of DV1179. The second stage of the trial will evaluate DV1179's
mechanism of action via inhibition of type 1 interferon by enrolling additional
SLE patients in selected dose groups. DV1179 was previously shown to be
well-tolerated in a Phase 1 trial in healthy subjects.
"To begin the evaluation of DV1179 in lupus patients is an important achievement
for Dynavax," said Tyler Martin, M.D., President and Chief Medical Officer at
Dynavax. "Excessive production of type 1 interferons is thought to be a critical
factor in the pathogenesis of lupus. At the completion of this trial, we will be
able to determine if DV1179 can reduce interferon levels in lupus patients."
About Dynavax's TLR Inhibitors
Dynavax's TLR inhibitors are a novel class of oligonucleotides, called
immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced
inflammatory response associated with autoimmune and inflammatory diseases.
Preclinical data from animal model studies show Dynavax's TLR inhibitors block
induction of IFN-alpha and also reduce symptoms in animal models of multiple
autoimmune diseases, such as lupus, inflammatory skin disorders, and rheumatoid
arthritis. The National Institutes of Health in Bethesda, MD and the Alliance for
Lupus Research contributed funding for Dynavax's preclinical work.
Peer-Reviewed Publications Document Program's Potential
In December, 2010, Dynavax reported in the JOURNAL OF EXPERIMENTAL MEDICINE (JEM,
Volume 207, page 2931) data that suggested an important role of the key innate
immune receptors TLR7 and TLR9 in a novel mouse model of skin conditions similar
to cutaneous lupus. The company's inhibitor of TLR7 and TLR9 prevented and
reversed disease suggesting therapeutic application of the inhibitor for the
treatment of cutaneous lupus and related skin conditions.
In the June 16, 2010 issue of NATURE, data demonstrated in both human blood cells
and animal models of lupus that glucocorticoid resistance characteristic of lupus
could be mediated through TLR7 and TLR9 and could be reversed by Dynavax's
TLR7/TLR9 inhibitor. Glucocorticoids are commonly used for the treatment of many
autoimmune and inflammatory conditions, but the high doses required for effective
treatment of lupus lead to significant side-effects and restrict the utility of
these drugs.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,
discovers and develops novel products to prevent and treat infectious and
inflammatory diseases. The Company's lead product candidate is HEPLISAV(TM), a
Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and
superior protection with fewer doses than current licensed vaccines. For more
information visit dynavax.com.
Forward-looking Statements This press release contains "forward-looking
statements," including statements related to the objectives of our clinical trial
in lupus patients and the potential features of the Company's inhibitors. 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 results
of completed studies can be replicated in human studies, difficulties or delays
in discovery or development, initiation and completion of preclinical or clinical
studies, the results of those studies and the impact of those results on the
initiation and completion of subsequent studies and issues arising in the
regulatory process; achieving our GSK agreement objectives and exercise of the
license option by GSK; our ability to obtain additional financing to support our
operations; and other risks detailed in the "Risk Factors" section of our current
periodic reports filed 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
SOURCE: Dynavax Technologies |
