Dynavax and AstraZeneca Amend Their Agreement for Asthma Drug Candidate
In a previously reported Phase 1a study of the safety of 4 weekly doses of AZD1419 compared to placebo in 45 healthy volunteers, ascending doses were well tolerated with no serious adverse events observed in treated subjects. Additional endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells.
On the basis of these encouraging results, the companies decided to bypass a planned Phase 1b trial and proceed to Phase 2a, a study that was to be conducted by
"Our partnership with AstraZeneca is focused on the advancement of AZD1419. This amendment will promote that objective by leveraging AstraZeneca's expertise in international clinical development of respiratory products," said
AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use. The Phase 2a study is planned to be initiated in 2016. For more information on this project, visit www.astrazeneca.com/what-science-can-do/tlr-9.html#.
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About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas -- respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology -- as well as in infection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.
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This press release contains "forward-looking statements," including statements related to the expected initiation of a Phase 2a trial. 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 the study will receive timely regulatory approval to proceed or results of completed studies can be replicated in further studies as well as difficulties or delays in discovery or development, initiation and completion of 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 AstraZeneca agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports
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