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Posted On: Monday, January 13, 2020
Posted By: John E. Harris
Tags: Vitiligo, Vitiligo Research, Vitiligo Treatment
Many have asked recently for an update about the treatment to target IL-15 to induce durable resp**es in patients with vitiligo. There was a lot of excitement around this approach when we published our paper about a year and a half ago in the summer of 2018 (read about it here), especially from me! The idea was that autoimmune memory cells form within vitiligo spots and are resp**ible for the return of disease at those exact same spots when treatments are stopped. We discovered that those cells need IL-15 to stay in the skin, and therefore blocking IL-15 removes them, reversing vitiligo, and avoiding relapse of disease when the treatment is stopped. This was all shown in mice, not humans yet. But we did study human skin and found the same cells and same pathways active, so we have good reason to believe that this will work for human patients as well.
Based on these exciting results, I applied for a grant from the Immune Tolerance Network (ITN), a group funded by the National Institutes of Health (NIH) to support human clinical trials to test drugs that could have long-lasting benefit for patients with autoimmune diseases. They thought this was a great idea as well and funded the grant application to prepare for a clinical trial in vitiligo patients. In this trial, we proposed to test an existing antibody that targets the cytokine IL-15. Of course, I helped prepare for the trial, which required getting approval from the FDA to conduct the trial, obtaining the drug, and writing the protocol (or plan) for the trial to follow.
During this process, I obtained support from Medicxi Ventures, a venture capital firm located in London and Geneva, to start my own company to create a drug to target this pathway for vitiligo as well. This is all great news, because it seems that many people (very smart and discerning people) agree that this could be a game-changing new treatment for vitiligo patients. As founder of this new company called Villaris Therapeutics, I have financial ties to the company, and therefore a potential “conflict of interest” or COI with the proposed trial sp**ored by the ITN. This means that if I could benefit personally from the success of the trial, there would be undue pressure on me when recruiting subjects, collecting data, etc.
Appropriately, everyone agreed that I could no longer lead the trial for the ITN because of my potential COI with Villaris Therapeutics, and thus the ITN elected a new “protocol chair” and principle investigator to lead the trial. This created a delay, and so the trial did not begin when it was projected, sometime in 2019. It is still planned to start soon, possibly in the spring of 2020, but unexpected delays can always occur, particularly because everyone is making sure the study is done safely and correctly. This is not a fast process and requires lots of patience. But it is still moving forward, and everyone is just as excited for the trial as we were over a year ago.
Now, we at Villaris believe that we are developing an even better drug than anything that’s currently available, and we are putting all of our effort into this. It’s no secret that our drug will target the IL-15 receptor rather than the cytokine, and for many reas** we think this will be a better strategy, more effective and thus longer-lasting, as well as safer. This is important and worth doing right, so we’re taking the time necessary to design this new treatment in a way that will benefit vitiligo patients the most. We actually don’t think it will take very long and hope to be testing it in early human trials within the next 2 years. Things are moving quickly because we’re passionate about this and it is our only goal. I’m working with the best of the best at Villaris – they’re brilliant, passionate, caring, and the personality types to “get it done”. Read more about the team and our approach at the company website at https://villaristherapeutics.com
So, don’t be discouraged that this drug isn’t ready yet, things are still moving full steam ahead and everyone just wants to be sure it’s safe, effective, and the best it can be. I’ll update everyone on progress when I can, but please know that I’m putting the same passion into this that I do everything else, including the clinic, our research, and advocacy work. Thank you for your support!
发布于:2020年1月13日，星期一
作者:John E. Harris
标签:白癜风，白癜风研究，白癜风治疗
最近，许多人要求对针对IL-15的治疗进行更新，以诱导白癜风患者的持久反应。大约一年半前，也就是2018年夏天，我们发表了一篇论文(请点击这里阅读相关内容)，围绕这个方法有很多令人兴奋的地方，尤其是我的文章!他们的想法是，自身免疫记忆细胞是在白癜风斑点内形成的，当治疗停止时，正是在这些相同的斑点上导致了疾病的复发。我们发现这些细胞需要IL-15来留在皮肤上，因此阻断IL-15可以去除它们，逆转白癜风，避免治疗停止后疾病复发。这些都是在老鼠身上发现的，而不是在人类身上。但我们确实研究了人类的皮肤，发现了同样的细胞和同样的通路是活跃的，所以我们有充分的理由相信这对人类病人也有效。
基于这些令人兴奋的结果，我向免疫耐受网络(ITN)申请了一笔资金，这是一个由美国国家卫生研究院(NIH)资助的组织，旨在支持人类临床试验，以测试对自身免疫性疾病患者具有长期疗效的药物。他们认为这是一个伟大的想法，并资助了拨款申请准备在白癜风患者的临床试验。在这项试验中，我们建议测试一种针对细胞因子IL-15的现有抗体。当然，我帮助准备了试验，这需要获得FDA的批准来进行试验，获得药物，并为接下来的试验编写协议(或计划)。
在这个过程中，我得到了Medicxi Ventures公司的支持，这是一家位于伦敦和日内瓦的风险投资公司，我开始了自己的公司，创造一种药物来针对白癜风的这一途径。这都是好消息，因为似乎很多人(非常聪明和有眼力的人)都认为这可能是一种改变游戏规则的治疗白癜风的新方法。作为这家名为Villaris Therapeutics的新公司的创始人，我与这家公司有经济上的联系，因此可能与ITN赞助的试验存在潜在的“利益冲突”或COI。这意味着，如果我个人能从试验的成功中受益，那么在招募受试者、收集数据等方面，我就会面临不应有的压力。
每个人都同意我不能再主持ITN的试验，因为我有可能与Villaris Therapeutics合作进行COI，因此ITN选举了一位新的“方案主席”和首席研究员来主持试验。这就造成了时间上的延迟，所以该试验并没有在预计的2019年某个时候开始。它仍计划很快开始，可能在2020年春天，但意外的延迟总是会发生，特别是因为每个人都在确保研究安全正确地进行。这不是一个快速的过程，需要很多的耐心。但它仍在前进，每个人都像一年多前一样对这个试验感到兴奋。
现在，我们维拉利斯相信，我们正在开发一种比现有的任何药物都更好的药物，我们正在为此付出所有的努力。我们的药物针对的是IL-15受体而不是细胞因子，这已经不是什么秘密了。出于许多原因，我们认为这是一个更好的策略，更有效，因此更持久，也更安全。这是重要的，值得做正确的，所以我们花必要的时间来设计这种新的治疗方法，以使白癜风患者受益最大。事实上，我们并不认为这需要很长时间，我们希望在未来两年内进行早期人体试验。事情进展得很快，因为我们对此充满激情，这是我们唯一的目标。我在维拉利斯和最优秀的人一起工作——他们才华横溢、充满激情、富有同情心，而且他们的性格也能让他们“完成任务”。更多关于该团队和我们的方法的信息，请访问公司网站https://villaristherapeutics.com
所以，不要因为这种药物还没有准备好而气馁，事情还在全速前进，每个人都想要确保它是安全的，有效的，并且是最好的。我会尽我所能向大家汇报进展情况，但请大家知道，我和其他所有工作一样，都投入了同样的热情，包括诊所、我们的研究和宣传工作。感谢您的支持!
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发表于 2020-1-15 07:09:40
发表于 2020-1-15 10:07:24