Dynavax Reports Phase 1B Results for Hepatitis B Therapy Candidate

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http://www.marketwire.com/press-release/Dynavax-Reports-Phase-1B-Safety-Immunogenicity-Results-Hepatitis-B-Therapy-Candidate-NASDAQ-DVAX-1373367.htm
SOURCE: Dynavax Technologies
        
                                                                                          
               
Dec 23, 2010 09:00 ET
Dynavax Reports Phase 1B Safety and Immunogenicity Results for Hepatitis B Therapy Candidate               
BERKELEY, CA--(Marketwire - December 23, 2010) - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported safety and immunogenicity data from its Phase 1b clinical trial of DV-601, its proprietary hepatitis B therapeutic vaccine. The dose escalation study assessed safety and the immunologic and virologic responses in 14 subjects with chronic hepatitis B infection. The Phase 1b data showed:
               

• All doses were generally safe and well tolerated; and
• Individual immunologic and virologic responses were observed across cohorts at all dose levels.
  

No conclusions regarding the potential clinical impact of the therapy could be reached in this small study. Dynavax's treatment approach combines both the surface and core hepatitis B virus (HBV) antigens with ISCOMATRIX® adjuvant originally entered into development by Rhein Biotech prior to its acquisition by Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune response against HBV-infected cells and if proven to be safe and effective, may offer an alternative therapeutic option for patients chronically infected with HBV.
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™, a Phase 3 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.
ISCOMATRIX® is a registered trademark of CSL Behring
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact         

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消息来源：Dynavax技术

2010年12月23日09:00东部
B型肝炎治疗的候选Dynavax报告阶段1B安全性和免疫原性结果

伯克利分校，加州- （影响Marketwire2008 -2010年12月23日） -Dynavax技术公司（纳斯达克股票代码：DVAX）今天公布了其安全性和免疫原性1b期数据的DV- 601，其专有的乙肝治疗性疫苗的临床试验。该研究评估剂量递增在14例慢性乙型肝炎受试者的安全和免疫学和病毒学反应。第一阶段1B数据显示：

    *所有剂量普遍安全，耐受性良好;和
    *个人免疫学和病毒学反应，观察整个世代在所有剂量水平。

没有结论对于临床治疗潜在的影响可能会达到这个小研究。 Dynavax的治疗方法结合了表面和核心乙型肝炎病毒ISCOMATRIX®佐剂（HBV）的发展进入了原来进入莱茵生物技术之前，其在2006年收购的Dynavax抗原。候选疫苗的DV- 601，目的是诱发抗HBV感染的细胞免疫反应，如果证明是安全有效的，可以提供另一种为慢性乙型肝炎病毒感染患者的治疗选择。

关于Dynavax

Dynavax技术公司是一家临床阶段的生物制药企业，以发现和开发新产品，以预防和治疗感染性疾病。公司的主导产品候选人HEPLISAV™，第3期成人乙肝疫苗研究用，旨在加强保护更加迅速，比目前获准生产的疫苗较少的剂量。欲了解更多信息，请访问www.dynavax.com。

ISCOMATRIX®是注册商标杰特贝林

联系方式：
迈克尔Ostrach
副总裁兼首席商务官
510-665-7257
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