开始IIB期临床试验以治疗与乙型肝炎相关的肝癌

StephenW

Phase IIB clinical trial initiated for treating hepatitis B-associated liver cancer              

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                            Reviewed by Emily Henderson, B.Sc.May 19 2020
The first patients have been dosed in a multi-regional Phase IIB randomized, placebo-controlled clinical trial for the treatment of hepatitis B-associated liver cancer.
Being tested in the first line setting is a first-in-class botanical drug candidate, YIV-906 (also known as PHY906 and KD018), whose development has been supported by the National Foundation for Cancer Research (NFCR) for two decades.
Patients began enrolling in the United States and Taiwan, with Hong Kong and Mainland China to follow. If, following these and future Phase III trials, the drug is approved by the U.S. Food and Drug Administration (FDA), it would be the country's first authorization for usage of a purely botanical cancer drug and usher in a new paradigm for drug discovery.
YIV-906 is an immune-enhancing and cytoprotective cancer therapeutic candidate which received orphan drug designation by the FDA in 2018 and that in preclinical studies has demonstrated:

• enhancement of both the innate and adaptive immune system in the tumor microenvironment--via polarizing M1 macrophanges and activating T-cells--when in combination with immunotherapy, chemotherapy and radiation therapies;
• protection of the gastrointestinal tract by reducing inflammation--via IL-6, NF-kappa-B, COX2, and iNOS pathways; and
• sped-up tissue regeneration by promoting progenitor and stem cell growth--via the WNT signaling pathway.
  

It is now being clinically tested in combination with sorafenib, which when administered as a monotherapy is often effective but causes dose-limiting side effects that result in one in three patients at least temporarily choosing to discontinue use.
In early-stage Phase I/II trials in liver, pancreatic and colorectal cancers, YIV-906 has demonstrated safety and promising efficacy, with the potential to improve survival and quality of life for patients.
The developer of YIV-906, Yung-Chi Cheng, Ph.D., Henry Bronson Professor of Pharmacology at Yale University, has been an NFCR-funded researcher since 1991. He has discovered or developed four approved small molecule drugs for the treatment of hepatitis B, cytomegalovirus and AIDS.
Dr. Cheng is a pioneer in pharmacology who is applying a systems biology approach to botanical medicines that address complex aging-associated diseases.
He and his laboratory are employing rigorous modern human drug validation principles and bioinformatics to learn from traditional medicines, and mechanism-based quality control to manufacture consistent complex mixtures.
Over the past two decades and with NFCR support, Dr. Cheng has transitioned his focus from small molecule to botanical drug discovery.

By mining human experience of botanical medicines--including traditional Chinese medicines (TCM)--using modern technology and techniques, he has developed the STAR (Signal Transduction, Action and Response) Discovery platform.
Among Dr. Cheng's most intensively reviewed and extensively published research has been that on YIV-906, the proprietary formulation of four herbs which he has been studying since 1999 that is now under clinical review.
The FDA created a new regulatory pathway for botanical drugs in 2004 and updated its Botanical Drug Guidance in 2016, creating new opportunities for botanical therapeutics--provided they demonstrate efficacy, safety and consistent batch-to-batch manufacturing.
Dr. Cheng and Yale University co-founded the company Yiviva to carry out human studies on YIV-906 and other herbal medicine formulas for multiple cancer indications.
It will be recruiting hepatitis B-associated liver cancer patients for twenty clinical sites, include Memorial Sloan Kettering Cancer Center, National Cancer Center of China, Taipei Medical University and Queen Mary Hospital in Hong Kong.
Over the past 29 years, NFCR has provided more than $1.8 million in basic cancer research funding to Dr. Cheng's lab at Yale University. The organization has also provided an additional $200,000 in translational cancer research funding to help develop the lab's proprietary botanical drug quality control and monitoring platform for complex mixtures.

We are excited about the start of multi-country Phase II clinical trials for YIV-906 and optimistic about its potential to improve the lives of cancer patients, as well as its vanguard role in possibly ushering in a new era of treatment--a convergence of Western and Eastern medicines"

Sujuan Ba, Ph.D., President and CEO, NFCR

"The National Foundation for Cancer Research has long differentiated itself from other organizations through our longstanding commitment to scientists and the flexibility we allow these innovators to explore truly untrodden ground," Dr. Ba continued. "We are very proud of standing firmly with Dr. Cheng in his decades-long quest to apply what he has termed 'WE--Western and Eastern--medicine' to cancer therapeutics."
"The National Foundation for Cancer Research has provided invaluable support to my research for several decades," stated Dr. Cheng. "I also know that NFCR shares my hope that the fruits of my lab's efforts can be demonstrated through a new paradigm to prevent, treat and cure cancer and other complex aging-associated diseases."
Source:
National Foundation for Cancer Research


        
         
                              

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Posted in: Drug Trial News | Medical Condition News

                                                        Tags: AIDS, Bioinformatics, Cancer, Cell, Chemotherapy, Clinical Trial, Colorectal, Cytomegalovirus, Drug Disco

StephenW

开始IIB期临床试验以治疗与乙型肝炎相关的肝癌

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艾米莉·亨德森（Emily Henderson），学士学位2020年5月19日

首批患者已在一项多区域IIB期随机，安慰剂对照临床试验中接受治疗，用于治疗与乙型肝炎相关的肝癌。

在第一线的环境中测试的是一流的植物候选药物YIV-906（也称为PHY906和KD018），其开发得到了美国国家癌症研究基金会（NFCR）的支持已有二十年了。

患者开始在美国和台湾入组，随后是香港和中国大陆。如果在这些以及以后的第三阶段试验之后，该药物获得了美国食品药品监督管理局（FDA）的批准，那么它将成为该国使用纯植物性癌症药物的首个授权，并为药物发现引入新的范例。

YIV-906是一种增强免疫力和细胞保护性癌症的治疗药物，已于2018年获得FDA的孤儿药称号，临床前研究表明：

与免疫疗法，化学疗法和放射疗法相结合时，通过极化M1巨噬细胞和激活T细胞来增强肿瘤微环境中的先天免疫系统和适应性免疫系统；
通过减少炎症-通过IL-6，NF-κB，COX2和iNOS途径保护胃肠道;和
通过促进祖细胞和干细胞生长-通过WNT信号通路加快组织再生。

现在正在与索拉非尼联用进行临床测试，索拉非尼单药治疗通常有效，但会产生剂量限制性副作用，导致三分之一的患者至少暂时选择停止使用。

在肝癌，胰腺癌和大肠癌的早期I / II期试验中，YIV-906已显示出安全性和有前途的功效，具有改善患者生存率和生活质量的潜力。

YIV-906的开发者，郑永志博士，耶鲁大学药理学教授亨利·布朗森（Henry Bronson）自1991年以来一直是NFCR资助的研究人员。他发现或开发了四种已获批准的小分子药物，可用于治疗糖尿病。乙型肝炎，巨细胞病毒和艾滋病。

郑博士是药理学的先驱，他将系统生物学方法应用于解决复杂的衰老相关疾病的植物药。

他和他的实验室正在采用严格的现代人类药物验证原理和生物信息学来向传统药物学习，并基于机制的质量控制来制造一致的复杂混合物。

在过去的二十年中，在NFCR的支持下，郑博士已将其重点从小分子转移到了植物药的发现。

通过利用现代技术和方法挖掘人类对植物药的经验，包括传统中药（TCM），他开发了STAR（信号转导，作用和响应）发现平台。

郑博士在YIV-906上进行了最深入的审查和广泛的研究，这是他自1999年以来一直在研究的四种草药的专有配方，目前正在临床审查中。

FDA于2004年为植物药创建了新的监管途径，并于2016年更新了《植物药指南》，为植物疗法创造了新的机会-前提是它们具有功效，安全性和逐批生产的一致性。

郑博士与耶鲁大学共同创立了公司Yiviva，以开展针对多种癌症适应症的YIV-906和其他草药配方的人体研究。

它将招募乙肝相关的肝癌患者进入二十个临床地点，包括斯隆·凯特琳纪念癌症中心，中国国家癌症中心，台北医科大学和香港玛丽医院。

在过去的29年中，NFCR已向耶鲁大学的郑博士的实验室提供了超过180万美元的基础癌症研究资金。该组织还提供了额外的20万美元转化癌症研究资金，以帮助开发实验室专有的植物药质量控制和复杂混合物监测平台。

我们对YIV-906的多国II期临床试验的开始感到兴奋，并对其具有改善癌症患者生活的潜力以及其在可能迎来新的治疗时代的先锋作用感到乐观西方和东方医学

BaSujuan博士，NFCR总裁兼首席执行官
Ba博士继续说道：“美国国家癌症研究基金会通过对科学家的长期承诺以及我们允许这些创新者探索真正不受阻碍的领域的灵活性，使自己与其他组织区分开来。” “我们很荣幸能与郑博士站在一起，在他长达数十年的探索中将他所说的'WE-Western and Eastern-medicine'应用于癌症治疗中。”

郑博士说：“几十年来，美国国家癌症研究基金会为我的研究提供了宝贵的支持。” “我也知道NFCR希望，可以通过预防，治疗和治愈癌症及其他与衰老相关的复杂疾病的新范例来证明我实验室的努力成果。”
资源：

国家癌症研究基金会