本帖最后由 风雨不动 于 2012-4-14 15:03 编辑
来自http://www.dynavax.com/hepatitis_bt.html
Our hepatitis B therapy, DV-601, completed Phase 1b clinical development in late 2010. We reported in a poster session Saturday, February 19 at the 21st Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) in Bangkok, Thailand new Phase 1b immunogenicity data for this potential new therapeutic option. The study evaluated three doses of the candidate therapeutic vaccine escalation in 14 patients with chronic hepatitis B infection, including six patients that were HBeAg negative and eight patients who were HBeAg positive, and found:
- The therapeutic regimen was safe and generally well tolerated at all dose levels;
- Most common systemic reactions were fatigue and malaise. No SAEs were recorded;
- DV601 was found to elicit immune responses at all dose levels, and anti-HBe antibodies were elicited in two of eight (2/8) patients;
- Anti-HBs antibodies were elicited in four of 14 (4/14) patients;
- Amongst the eight HBeAg positive patients, two had HBeAg clearance, and one of those individuals also had HBsAg clearance;
- Three patients are still in the follow-up observation period.
Our novel treatment approach, which for the first time combines both the surface and core hepatitis B virus (HBV) antigens, may offer a more effective therapeutic option for patients chronically infected with HBV. However, no conclusions regarding the potential clinical impact of the therapy could be reached in this small study. We have retained all commercial rights to this product.
有道自动翻译大家凑合着看:
我们的乙型肝炎治疗、DV - 601页,年完成Phase 1b阶段1 bclinical development in late 2010. 临床开发在2010年底。We reported in a poster session Saturday, February 19 at the 21st Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) in Bangkok, Thailand new Phase 1b immunogenicity data for this potential new therapeutic option. 我们报道了一张海报会议,今天是2月19日,二十一号召开的亚太肝脏研究联合会(APASL 2011)在曼谷,泰国新阶段免疫原性数据1 b潜在的新治疗的选择。The study evaluated three doses of the candidate therapeutic vaccine escalation in 14 patients with chronic hepatitis B infection, including six patients that were HBeAg negative and eight patients who were HBeAg positive, and found:这��研究评价三个剂量的候选人升级的治疗性的疫苗14例慢性乙肝感染,包括6个病人,HBeAg阴性和8个患者阳性HBeAg,发现:
- The therapeutic regimen was safe and generally well tolerated at all dose levels;治疗方案是安全的,在所有剂量耐受性良好的程度;
- Most common systemic reactions were fatigue and malaise. 最常见的系统性反应疲劳和不适等。No SAEs were recorded;记录没有节约;
- DV601 was found to elicit immune responses at all dose levels, and anti-HBe antibodies were elicited in two of eight (2/8) patients;DV601引发免疫反应被发现在所有剂量水平,anti-HBe诱发抗体则是两个八(2/8)患者;
- Anti-HBs antibodies were elicited in four of 14 (4/14) patients;Anti-HBs亢奋的抗体则是四14(4/14)患者;
- Amongst the eight HBeAg positive patients, two had HBeAg clearance, and one of those individuals also had HBsAg clearance;在八HBeAg积极的患者,两人已经HBeAg报关、其中的个人也有HBsAg间隙;
- Three patients are still in the follow-up observation period.三个病人仍在后续观察期。
Our novel treatment approach, which for the first time combines both the surface and core hepatitis B virus (HBV) antigens, may offer a more effective therapeutic option for patients chronically infected with HBV. 我们的新颖的治疗方法,结合第一次表面和核心乙型肝炎病毒(HBV)抗原,可以提供一个更有效的治疗选择与患者慢性感染HBV。However, no conclusions regarding the potential clinical impact of the therapy could be reached in this small study. 然而,没有结论对于潜在的临床治疗的影响就能在这个研究。We have retained all commercial rights to this product.我们有权利保留所有的商业产品。
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