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shekai

新虫 (初入文坛)

[求助] 关于HSV-2生殖器疱疹病毒的研究进展与攻克期待。 已有2人参与

有数据显示美国人有近6000万(近人口总数20%)感染了HSV-2生殖器疱疹病毒,该病很容易复发,是性传播疾病一种,而且,听说HSV-2和HSV-1两种病毒比艾滋和肝炎病毒等都要简单点,HSV-2在人体不能得到根本清除是由于部分影藏在神经细胞中,而类似于阿昔洛韦这类药物不能进入这类细胞,只能在发病时候,进行治疗。

这是一个很大的市场,听说美国在研究根治的方面投入较大。

我本人是学工科的,但知道今后几十年,在基因和纳米领域,科技很可能会有突破技术发生。

我想请问各位研究病毒学的同学,就您们的了解,人类攻破该类病毒,得到彻底治愈的药物还会要多长时间列?

非常谢谢!期待您们的回复。

[ Last edited by silicare on 2014-2-18 at 09:00 ]
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qlxbya

新虫 (初入文坛)

转个我看到的国外消息:
“Earlier this year I discussed Vical (VICL), one of those biotechnology companies that appear to be flying under almost everyone's radar. The corporation, based in San Diego, CA, has, for a young biotech company, a deep pipeline as well as two products on the market, one to protect farm-raised salmon and another to increase the survival time of dogs with oral melanoma. But what really excites me about Vical, in addition to its work on cancer immunotherapies and, specifically, its Phase III study of Allovectin®, is the company’s seminal research and development in the area of the herpes simplex virus and the development of the corporation’s herpes simplex virus type 2 or HSV-2 vaccine.

在美guo加州的这家公司就是 vical  它是一家主要致力研究治疗生殖器疱疹的生化公司。( 迷糊以前提及过这个药而且多次提及。  )这家公司目前主要专攻癌症的免疫力治疗还有就是已经进入三期实验的专制生殖器疱疹的药名叫  allovectin  目前此药已经申请专利并注册。  这是一个疫苗药物。  

Of the two serotypes identified, HSV-1 and HSV-2, the latter is most common in the United States. HSV-2 is a sexually transmitted virus which is the leading cause of genital herpes. Approximately one out of every six individuals in the United States and an estimated one out of every four worldwide is infected by HSV-2 before age 50. Even more disconcerting, perhaps, as noted by Vical at the recent BIO International Convention,

二型疱疹是性病在美guo很普遍。  每六个人中就有一个人有这个病, 世界范围内五十岁之前的人每四个人就有一个人有此病。  在今年召开的那次生化会议上  这家公司把这些都做了论述


“[I]n the United States, at least 40 million people are infected with HSV-2, and approximately 1.6 million people are newly infected each year, with approximately 500,000 of those suffering from disease symptoms. Even higher infection rates are evident in developing countries, with further complications in people also infected with HIV.”

在美guo四千万人患有此病。  每一年新病人160万人。  其中这些病人中50万人是有疾病症状的。  (这说明大多数人得病没有症状, 而我们这些倒霉蛋都是有症状的)  发展中guo家呈现上升趋势, 艾滋患者的症状更复杂


Importantly, there is, currently, no cure for genital herpes. It is a recurrent, lifelong viral infection. But under a grant from the National Institute of Allergy and Infectious Diseases Division of the National Institutes of Health ((NIH)), the effort mounted by Vical is directed at developing a plasmid DNA-based vaccine to inhibit recurring lesions in patients latently infected with HSV-2. And while still in the preclinical stage, results have shown a reproducible statistically significant reduction in viral lesion occurrence in guinea pigs latently infected with HSV-2.

此病无法治愈。  是终生的病毒感染  (真难过)  但是在guo家健康部门的授权下, 这家公司正致力研究对付二型疱疹的基因基础的疫苗来对付疱疹的复发。 虽然还没有人体试验, 但是在猪身上的试验已经成功, 能够抑制复发

Development of the HSV-2 vaccine is being done in collaboration with the University Of Washington School Of Medicine and the Sealy Center for Vaccine Development at the University of Texas Medical Branch under the NIH grant cited above. The initial focus will be for people already infected with HSV-2, with the goal of reducing or eliminating periodic viral flare-ups as well as viral shedding and transmission.

这项试验是与华盛顿大学和德克萨斯大学一起联合进行的。  是针对已经感染生殖器疱疹病人的。  抑制复发, 防治传染已经减轻症状。  还有消灭病毒的活跃

What had researchers and medical practitioners excited at this year’s BIO International Convention were data presented by Vical that showed its therapeutic vaccine “…significantly reduced the recurrence of HSV-2 lesions in guinea pigs with latent infection (p<0.05).” Vical also presented data for a related prophylactic vaccine that demonstrated how this version “…protected mice against lethal HSV-2 challenge (p<0.0001), provided sterilizing immunity(p<0.05) and inhibited post-challenge viral shedding at the primary infection site (p<0.05) and viral load at the latent infection site (p=0.007).”

在今年的世界生化大会上, 这家公司公布了在猪身上实验的所有数据。  以及在耗子身上的试验结果。  数据显示彻底被抑制。  

What some consider even more exciting were the results announced a month later at the DNA Vaccines 2011 Conference. According to Sean M. Sullivan, Ph.D., Vical's Executive Director of Pharmaceutical Sciences,

八月的大会这家公司的老板又宣布了好消息。  用了这个疫苗根本不会复发, 在猪身上显示成功

“[A] Vaxfectin®-formulated trivalent therapeutic version of the vaccine … significantly reduced (p<0.05) the recurrence of lesions in guinea pigs with latent infection as well as viral shedding.” In addition “… a 0.1 µg dose of the prophylactic vaccine provided 100% protection of mice against challenge with 50 times a lethal dose, and a 100 µg dose of the prophylactic vaccine provided 100% protection of mice against challenge with 500 times a lethal dose. The 100 µg dose of the prophylactic vaccine also significantly reduced viral shedding at the primary infection site (p<0.001) and inhibited viral counts at the latent infection site (pd0.05). Both the monovalent and trivalent vaccines completely eliminated primary disease and recurrent disease in a prophylactic guinea pig model.”



To say these results are significant is understatement. However, whether or not Vical can achieve equally compelling results in the clinic with human subjects obviously is the key question, and one for which both the medical and financial communities await an answer. After all, according to Vical, estimated direct costs of treating HSV-2 in the United States alone are close to $1 billion annually, primarily for drugs and outpatient medical care, plus additional indirect costs of more than $200 million. If the company is successful in developing an FDA-approved HSV-2 vaccine formulated with its Vaxfectin® adjuvant, the revenues in the US alone would push VICL into biotech’s major leagues.

猪身上成功了不能说明问题, 人身上成功才是关键。  每一年在美guo在二型疱疹上的病人买药消费达到十亿美金。  还有近两亿美金的间接消费。  如果这家公司成功把此药推向市场 那光是美guo的营业额就是一个天文数字了吧。  (如果哪家公司在这各方面成功那将是创造神话, 不光是印钞机了)  ”

我的问题是,人体试验成功可能性是不是仍然很小列?

对于药物研发,是不是大多数是在人体试验阶段失败的啊?

谢谢!
10楼2011-08-31 15:23:42
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shekai

新虫 (初入文坛)

自己先顶一下。

请有所了解的同学帮忙给点意见。

非常感谢了。。。
2楼2011-08-26 20:10:35
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qlxbya

新虫 (初入文坛)

不了解,请了解的同学发言。同样关注中。。。。
3楼2011-08-27 08:36:11
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shekai

新虫 (初入文坛)

自己顶起下,期待回复。
4楼2011-08-27 16:28:16
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