Argos艾滋病免疫疗法AGS-004临床二期未达到预期目标

Argos艾滋病免疫疗法AGS-004临床二期未达到预期目标

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发布日期：2015-01-10  来源：生物谷  

Argos公司宣布治疗艾滋病免疫疗法AGS-004的临床二期研究未能达到预期效果，让不少人大为失望。

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2014年癌症的免疫疗法研究如火如荼。另一方面，一些生物医药公司开始利用这一思路来治疗一些病毒性疾病。相对于癌症这种自身疾病，病毒类疾病有更好的抗原性，因而免疫疗法更有可能在这一领域起到良好作用。而Argos医药公司就是这一领域中的先行者之一。

然而，最近公司宣布，公司开发的治疗艾滋病免疫疗法AGS-004的临床二期研究未能达到预期效果，让不少人大为失望。

简单来说，AGS-004是通过刺激人体T细胞，使其能够更好分辨体内的艾滋病病毒，进而达到治疗效果。这项研究是在美国NIH的资助之下进行的，研究人员招募了54名艾滋病患者，其中实验组每月接受4次AGS-004治疗，同时实验组和对照组在治疗过程中接受最低限度的标准抗病毒治疗（ART）。

当四次治疗过后，同时中断实验组和对照组的ART治疗并在十二周后检测两组之间HIV含量。不过，遗憾的是，研究结果未能表现出明显差异。这也直接导致公司股价下挫。

然而，此次临床二期研究并非一无是处，研究人员在检测中发现，AGS-004激起的记忆T细胞反应效率高达70%，这也暗示这一药物能够用于促使免疫系统长期杀灭HIV病毒。而HIV最令人头痛的地方就在于病毒会形成许多包涵体，潜伏在患者体内，很难被清除。另一方面，研究人员认为加大AGS-004的治疗剂量和频率或许会有更为明显的作用。不过，公司CSO Charles Nicolette同时也承认，现在对于HIV如何逃避免疫系统监控认识不足仍然是制约AGS-004开发的一个重要问题。

Argos公司2014年融资4500万美元用于开发其独有的免疫疗法技术平台。目前公司还有AGS-003处于临床三期研究阶段。AGS-003是利用类似技术治疗肾细胞癌的癌症免疫疗法。

详细英文报道：

Argos Therapeutics' ($ARGS) HIV treatment failed to meet its main goal in a midstage trial, raising concerns about the company's platform technology and sending its shares spiraling downward.

The treatment, AGS-004, is a personalized immunotherapy designed to train patients' T cells to better attack HIV. In a placebo-controlled Phase IIb trial, AGS-004 missed its primary endpoint of significantly lowering viral load among chronically infected patients, the company said, news that spurred a 27% dro in Argos' share value on Friday morning.

The study, paid for by the National Institutes of Health, enrolled 54 patients, giving them four doses of either AGS-004 or placebo every month while maintaining baseline treatment with standard antiretroviral therapy (ART), the company said. After the fourth dose, Argos interrupted ART dosing for both groups, measuring viral load after 12 weeks to see how AGS-004 stacked up versus placebo.

Despite the miss on efficacy, the Durham, NC, biotech is looking on the bright side. AGS-004 led to memory T cell responses in the 70% of the patients who completed the trial, Argos said, a sign that the immunotherapy has potential as a treatment for persistent HIV infection rather than the chronic variety. And that's an encouraging development for Argos' ongoing HIV eradication study and its soon-to-begin pediatric trial, Chief Scientific Officer Charles Nicolette said.

"These data support our plans to continue testing AGS-004 in the studies aimed at decreasing or eliminating the latent HIV reservoir," Nicolette said in a statement. "In addition, based on these data we believe that more frequent dosing of AGS-004 during ART may provide further benefit, but also highlight the need to better understand the mechanisms of immune evasion employed by the HIV virus in the absence of ART."

Argos squeaked out a $45 million IPO last year, taking a sizable discount but raising the cash it needed to launch a Phase III trial for AGS-003, its lead candidate. Using the same technology as its HIV treatment, AGS-003 is an immunotherapy that uses a patient's own dendritic cells to fight cancer growth, and it's now in the midst of a Phase III trial in patients with renal cell carcinoma.