ARC-520

齐欢畅2

每天进步一点点，总有一天高墙会倒，让正义的光芒照亮每一个战友的心。2015年更加积极的面对生活，面对工作，积极改变自己的处境，每个人都雄起了，都积极了，那歧视消亡的日子也就到来了，因为只有内心强大了，我们才能无所畏惧，走向人生的坦途，记住打败我们的人只有自己，谁也无法把你怎么样。

newchinabok

对基因药，免疫药的认识：

基因药，免疫药选择试验病人都为没治疗病人，hbsag高，hbvdna高,肝功不正常，难度大，门槛高，治疗结果不能轻易否定。

其实真正病人都经过核苷药长期治疗或携带者，hbsag低，hbvdna阴,肝功正常，难度小很多，可能更容易显现效果

战天斗hbv

回复 newchinabok 的帖子

看过版里的很多文章了，特别是乙肝基金会的那个主席的ppt，乙肝治愈就两种，一个是临床治愈，即现在核苷类达到的效果，一个直译是功能治愈，但是功能治愈的解释就是表抗阴转。我理解得对吗？我记得那个ppt就是你发的。4，50页那个。

战天斗hbv

回复 newchinabok 的帖子

所以520以“功能治愈”为目标，就是我们说的表抗阴转。不然就是Clinical cure临床治愈了。我是这么理解的。

战天斗hbv

Defining a Cure: Goals
• Clinically: returning a chronic hepatitis B
carrier to the level of risk of death due to liver
disease of someone with a resolved infection
• Functionally: enduring suppression of all
measurable viral markers (antigenemia and
viremia) and restoration of humoral sAb
功能治愈是包括[size=1.3em]restoration of humoral sAb的，我英语残疾，不对的望包涵

战天斗hbv

如果只是传统的临床治愈，拿来开刀的就不应是表抗了，

newchinabok

现在大家都没治愈，不能停药，停药就返弹，我心目中的治愈是表面抗原转阴，有抗体，能停药

newchinabok

现在都没治愈，我心目的治愈是表面抗原转阴，有抗体，能停药

战天斗hbv

回复 newchinabok 的帖子

我和你想的一样，表抗转阴，有抗体就是治愈，也就是目前各公司提出的功能治愈

齐欢畅2

Arrowhead Provides Update on IND for ARC-520 Phase 2b Study

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company in a preliminary call of a partial clinical hold, under which the Company is cleared to begin a modified multiple-dose study of ARC-520 in patients with chronic hepatitis B infection. The FDA requested that the Company start the multiple-dose study at 1 mg/kg of ARC-520 rather than the proposed parallel study design of 2 and 4 mg/kg, and requested additional information be provided to the agency. The additional information includes a final study report from the single-dose Phase 2a study in patients who received 1-4 mg/kg ARC-520, which is ongoing and has not reported any serious adverse events or evidence of end organ toxicity to date. The FDA also requested a final study report from an ongoing multiple-dose non-clinical study, which has shown ARC-520 to be well tolerated with no evidence of end organ toxicity to date. The FDA committed to provide the Company with a letter detailing its thoughts and requests within 30 days. The ongoing Phase 2a study continues as planned, and the Company expects to file with Asian and European agencies to begin additional Phase 2b studies in coming weeks.

"Over the next 30 days, Arrowhead will begin preparations for the multiple-dose Phase 2b study," said Arrowhead President and CEO, Dr. Christopher Anzalone. "We will work closely with the FDA throughout this process while we continue to seek approval to proceed with other planned studies in Asia and Europe."