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
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
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.
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™, 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 www.dynavax.com.
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
Vice President and Chief Business Officer
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