DYNAVAX（DVAX）将继续HEPLISAV-B阶段3不变​​继第三次审查DSMB

StephenW

Dynavax (DVAX) Will Continue HEPLISAV-B Phase 3 Unchanged Following Third DSMB Review
Dynavax Technologies Corporation (NASDAQ: DVAX) announced that the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from HBV-23, the ongoing Phase 3 clinical study of HEPLISAV-B, Dynavax's investigational adult hepatitis B vaccine, has completed its third prespecified review and has recommended that the study continue unchanged.
The third DSMB review included safety data for all enrolled subjects collected through the data cut-off in June. As of the cut-off, all continuing subjects who had received the second immunization (which was the last active dose for HEPLISAV-B subjects) had reached at least 8 months of the requisite one year follow-up after the second immunization. The DSMB reviewed unblinded tables and listings presenting key safety data. Based on this review, the DSMB recommended continuing HBV-23 with no change to the study.
Over 2,200 subjects have completed their final study visit and all study visits for HBV-23 are expected to be completed by October 2015. Top line results are expected to be released by early 2016.
Separately, Dynavax announced that its cash, cash equivalents and marketable securities at June 30, 2015 were approximately $93.4 million, which does not include approximately $28.8 million in additional cash resulting from stock sales following the end of the quarter under the Company's at-the-market sales agreement ("ATM agreement"). The ATM agreement has concluded because the Company has reached $50 million of gross proceeds as specified in the ATM agreement. At July 8, 2015, the Company had approximately 31,400,000 shares of common stock outstanding and approximately 17,000 shares of preferred stock outstanding which are convertible into approximately 1,700,000 shares of common stock.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

StephenW

DYNAVAX（DVAX）将继续HEPLISAV-B阶段3不变​​继第三次审查DSMB
文章

DYNAVAX Technologies公司（纳斯达克股票代码：DVAX）宣布，独立的数据安全监督委员会（DSMB）负责定期从HBV-23检讨安全数据，HEPLISAV-B，Dynavax公司的研究性成人乙肝疫苗正在进行三期临床研究，有完成了预先设定的第三次审查和建议，研究继续持平。

第三DSMB审查包括安全数据通过数据截止六月收集所有已登记科目。作为截止，收到了第二次免疫（这是最后一个活动剂量HEPLISAV-B科目）谁所有科目继续达到至少8个月所需的年追踪行动的第二次免疫后。在DSMB审查揭盲表和目录提交关键的安全数据。在此基础上审查，DSMB建议继续HBV-23没有变化的研究。

2200受试者已经完成了他们最后的考察访问，并为所有考察访问HBV-23预计将在2015年十月前行的结果预计将在2016年年初发布完成。

另外，Dynavax公司宣布，在二零一五年六月三十零日其现金，现金等价物及有价证券约为93400000美元，其中不包括股票本季度销售额根据本公司的AT-任何─结束后约28800000美元的额外现金产生市场销售协议（“协议ATM”）。该ATM协议已经结束，因为公司已经达到总收益的50万​​元作为ATM协议中规定。在2015年7月8日，本公司已发行普通股约3140万股，并拥有大约1.7万名股优先股优秀可转换为普通股的约170万股份。

关于HEPLISAV-B

HEPLISAV-B是一种研究成人B型肝炎疫苗，它结合乙肝表面抗原与专有Toll样受体9激动剂来增强免疫应答。 DYNAVAX在全球商业权利HEPLISAV-B。