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本帖最后由 StephenW 于 2015-2-16 21:48 编辑
8 Feb 2015 extracts from webcast
As we discussed on our last call, these are important data. We believe that ours is the first report demonstrating s-antigen reduction in humans after a single dose.
This is something the field has been trying to accomplish for quite some time and
the fact that we have done it is encouraging. This was only the beginning of our Phase 2a single dose escalation study, and we have since completed dosing both
3 & 4 mg/kg cohorts. We are still following the 4mg/kg cohort and both the 3 and 4
mg/kg groups remain blinded. The safety profile for ARC-520 appears to continue to be very good. We have still not seen any signs of end organ toxicity and no reported AEs have been rated as severe or serious. We expect to have unblinded data that we can discuss next quarter.
We made substantial progress last quarter.As we look at calendar 2015, there are
several key goals we hope to meet. They are:
1. Complete the Phase 2a single dose study of ARC-520 and discuss the 3 and
4 mg/kg data. We believe that will happen next quarter.
2. Complete the initial cohort of the US Phase 2b study of ARC-520 and escalate
to a higher dose as necessary.
3. Fully enroll the initial 3-month portion of the Phase 2b studies of ARC-520
in Europe and Asia.
4. Begin long-term extension Phase 2b studies of ARC-520 in Europe and Asia. These are designed to go out as long as 9 months immediately after the 3-month lead in studies.
5. Begin exploratory combination studies with ARC-520.
6. Begin exploratory studies with ARC-520 at different dosing schedules.
7. Begin dosing the ARC-AAT Phase 1 study this month.
8. Complete dosing of healthy volunteers and patients in the ARC-AAT Phase 1 study.
9. Present data from the ARC-AAT Phase 1 study.
10. Launch a multiple dose Phase 2 study of ARC-AAT.
11. File an IND or equivalent for a 3d clinical candidate.
12. Nominate our first subcutaneous administration candidate or first extra
hepatic candidate.
13. Expand our RNAi chemistry toolbox to broaden the ways we can achieve
freedom to operate in additional indications and targets.
.从网络直播2015年2月8日精华
正如我们在我们的最后一次通话中讨论，这些都是重要的数据。我们相信，我们是第一个报告表明表面抗原减少人类单剂量之后。
这是后话了现场一直试图完成的相当长的一段时间，
事实上，我们已经做了很令人鼓舞。这是我们的2a期单剂量递增研究的开端，此后我们一直完成配料均
3＆4毫克/公斤的同伙。我们仍然遵循为4mg/ kg群组和两个3和4
毫克/公斤的团体依然蒙蔽。对于ARC-520的安全性似乎仍是非常好的。我们还没有看到结束器官毒性的任何迹象，也没有报告不良事件被评为严重或严重。我们期望有揭盲数据，我们可以讨论下个季度。
我们取得了实质性进展最后quarter.As我们看一下2015年的日历，还有
几个关键目标，我们希望能够见面。他们是：
1.完成ARC-520的2a期单剂量研究和讨论3,4毫克/公斤的数据。我们相信会发生下一季度。
2.完成ARC-520的美国2b期研究的初始队列和升级到一个更高的剂量是必要的。
3.完全招收第一期的初始3个月部分ARC-5202B研究在欧洲和亚洲。
4.开始长期延伸阶段ARC-5202B研究在欧洲和亚洲。这些设计的3个月期铅的研究后，只要出去9个月马上。
5.开始与ARC-520的探索相结合的研究。
6.开始与ARC-520的探索性研究，在不同的给药方案。
7开始在本月加药的ARC-AAT1期研究。健康志愿者和患者的ARC-AAT第一阶段的研究8.完成计量。
从ARC-AAT1期研究9.目前的数据。
10.启动ARC-AAT的多剂量2期研究。
11.文件的IND或等效的3D临床候选人。
12.提名我们第一次皮下注射候选人或第一个加肝候选人。
13.扩大我们的RNAi化学工具箱拓宽我们可以实现途径
自由工作在其它适应症和目标。
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楼主: 林伍伍
发表于 2015-2-16 21:41
