A Phase 1b/2a, Open-label, Multicenter, Randomized, Dose Escalation Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination with Valganciclovir and Atezolizumab/Bevacizumab in Subjects with Hepatocellular Carcinoma

This study is to evaluate the safety, tolerability, efficacy and immunogenicity of RZ-001 in combination with Valganciclovir (VGCV) and Atezolizumab/Bevacizumab when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.

开始日期2024-12-01

申办/合作机构

Rznomics Co., Ltd.

NCT06102525 / Recruiting临床1/2期

A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, and Efficacy of RZ-001 in Combination with Valganciclovir in Subjects with Glioblastoma

This is a Phase 1/2a, open-label study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 administered in combination with VGCV in subjects with hTERT-positive GBM.

开始日期2024-10-08

申办/合作机构

Rznomics Co., Ltd.

NCT05595473 / Active, not recruiting临床1/2期

A Phase 1/2a, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability and Efficacy of RZ-001 in Combination with Valganciclovir in Subjects with Hepatocellular Carcinoma

This is first in human study to evaluate the safety, tolerability, immunogenicity, and preliminary clinical activity of RZ-001 when given to subjects with human telomerase reverse transcriptase (hTERT)-positive HCC.

开始日期2022-07-29

申办/合作机构

Rznomics Co., Ltd.

100 项与 RZ-001 相关的临床结果

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100 项与 RZ-001 相关的转化医学

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100 项与 RZ-001 相关的专利（医药）

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项与 RZ-001 相关的文献（医药）

2022-07-30·The Plant cell1区 · 生物学

Progressive chromatin silencing of ABA biosynthesis genes permits seed germination in Arabidopsis

1区 · 生物学

Article

作者: Wu, Yufeng ; Yang, Deyue ; Chen, Min ; Zhu, Danling ; Qu, Li-Jia ; Kong, Xiangxiong ; Chen, Xi ; Wu, Zhe ; Du, Jiamu ; Zhao, Fengli

Abstract:

Seed germination represents a major developmental switch in plants that is vital to agriculture, but how this process is controlled at the chromatin level remains obscure. Here we demonstrate that successful germination in Arabidopsis thaliana requires a chromatin mechanism that progressively silences 9-CIS-EPOXYCAROTENOID DIOXYGENASE 6 (NCED6), which encodes a rate-limiting enzyme in abscisic acid (ABA) biosynthesis, through the cooperative action of the RNA-binding protein RZ-1 and the polycomb repressive complex 2 (PRC2). Simultaneous inactivation of RZ-1 and PRC2 blocked germination and synergistically derepressed NCEDs and hundreds of genes. At NCED6, in part by promoting H3 deacetylation and suppressing H3K4me3, RZ-1 facilitates transcriptional silencing and also an H3K27me3 accumulation process that occurs during seed germination and early seedling growth. Genome-wide analysis revealed that RZ-1 is preferentially required for transcriptional silencing of many PRC2 targets early during seed germination, when H3K27me3 is not yet established. We propose RZ-1 confers a novel silencing mechanism to compensate for and synergize with PRC2. Our work highlights the progressive chromatin silencing of ABA biosynthesis genes via the RNA-binding protein RZ-1 and PRC2 acting in synergy, a process that is vital for seed germination.

2020-03-01·Pathogens and disease4区 · 医学

Bacillus subtilis RZ001 improves intestinal integrity and alleviates colitis by inhibiting the Notch signalling pathway and activating ATOH-1

4区 · 医学

Article

作者: Li, Zhongyuan ; Zhang, Tengxun ; Gai, Sailun ; Wang, Nan ; Song, Yajian ; Luo, Xuegang ; Geng, Meng ; Qi, Wei ; Li, Yanru ; Zhang, Tongcun ; Guo, Congcong

ABSTRACT:

Intestinal mucosal barriers help the body resist many intestinal inflammatory diseases, such as inflammatory bowel disease (IBD). In this study, we identified a novel bacterium promoting the repair of intestinal mucosa and investigated the potential mechanisms underlying its activity. Culture supernatant of Bacillus subtilis RZ001 upregulated the expression of mucin 2 (MUC2) and tight junction (TJ) proteins in HT-29 cells in vitro. Oral administration of B. subtilis RZ001 may have significantly reduced symptoms such as the dextran sulfate sodium (DSS)-induced decrease in body weight, shortening of colon length and overproduction of proinflammatory factors. The number of goblet cells and levels of MUC2 and TJ proteins were significantly increased in adult mice fed with B. subtilis RZ001. B. subtilis RZ001 cells upregulated the levels of MUC2 in the intestinal organoids. Furthermore, culture supernatant of B. subtilis RZ001 could suppress the Notch signalling pathway and activate the expression of atonal homolog 1 (Atoh1). The transcription factor Atoh1 is required for intestinal secretory cell differentiation and activates transcription of MUC2 via binding to E-boxes on the MUC2 promoter. Taken together, B. subtilis strain RZ001 has the potential for treating IBD. The present study is helpful to elucidate the mechanisms of B. subtilis action.

2014-12-01·Phytotherapy research : PTR2区 · 医学

Anti‐inflammatory Effects of Ginsenosides Rg₅, Rz₁, and Rk₁: Inhibition of TNF‐α‐induced NF‐κB, COX‐2, and iNOS transcriptional expression

2区 · 医学

Article

作者: Lee, Sang Myung

In the course of this experiment on the anti‐inflammatory effect of ginsenosides, protopanaxdiol ginsenosides have shown inhibition activities in inflammatory responses: NF‐κB, COX‐2, and iNOS were induced by TNF‐α. The responses of this experiment were evaluated by NF‐κB‐luciferase assay and RT‐PCR experiment of COX‐2 and iNOS genes. The NF‐κB expressions were inhibited by ginsenosides Rd, Rg5, Rz1, and Rk1 in a dose‐dependent manner. The IC50 values were 3.47, 0.61, 0.63, and 0.75 μM, respectively. Particularly, ginsenosides Rg5, Rz1, and Rk1 as converted ginsenosides from primary protopanaxdiol ginsenosidess significantly inhibited COX‐2 and iNOS gene expression. These inhibition levels were similar to sulfasalazine as reference material. Copyright © 2014 John Wiley & Sons, Ltd.

项与 RZ-001 相关的新闻（医药）

2024-11-25

·PRNewswire

Rznomics announces to secure the Expanded Access Program for patients with Glioblastoma (GBM)

SEONGNAM, South Korea, Nov. 25, 2024 /PRNewswire/ -- Rznomics, Inc. announced to secure its expanded access program (EAP) from the United States Food and Drug Administration (FDA) for RZ-001, RNA editing gene therapy product for the treatment of patients aged 18 and older with Glioblastoma (GBM). Generally, the EAP also known as 'compassionate use,' is a pathway provided by the U.S. FDA that allows patients with serious or immediately life-threatening conditions to gain access to investigational medical products (drugs, biologics, or medical devices) outside of clinical trials. GBM is known as the most malignant tumor in Central Nervous system with high mortality rate but lacks effective therapies. TERT promoter mutations, which are associated with TERT upregulation, are found in up to 80% of glioblastoma (GBM) patients. This increased TERT expression is strongly linked to a poor prognosis, reflecting the aggressive nature of the disease. RZ-001, the RNA replacement enzyme-based cancer gene therapy, targets and cleaves hTERT mRNA and replaces the mRNA with the therapeutic gene RNA. This induces anti-cancer activity and cytotoxic effect by reducing hTERT expression and simultaneously trans-ligating an HSVtk-encoding sequence into the reprogrammed hTERT mRNA. "We are excited to offer RZ-001 through this EAP, providing a potential new treatment option for GBM patients with limited alternatives," said Dr. Chiocca, Professor at Harvard Medical School executive Director of the Center for Tumors of the Nervous System at Mass General Brigham Cancer Institute. Seong-Wook Lee, PhD, CEO of Rznomics, stated, "We hope RZ-001 can serve as a good alternative for patients who have had difficulty with existing treatments." He also assured that the Rznomics team is committed to expediting the clinical development process to secure timely market authorization. In previous releases, Rznomics noted that RZ-001 has received Fast Track designations and Phase I/IIa IND approval for RZ-001 from the FDA and the South Korean Ministry of Food and Drug Safety (MFDS) in Glioblastoma and the clinical trial has been investigating the safety, tolerability, and efficacy of RZ-001 in patients with GBM. A clinical trial has recently commenced, marking the start of RZ-001 administration. About Rznomics As a biopharmaceutical company founded in the laboratory of Professor Seong-Wook Lee, Dankook University Department of Bioconvergence Engineering, Rznomics is researching with the goal of developing new RNA-based gene therapeutic bio-drugs for cancer and incurable diseases. Rznomics' core platform technology is based on an RNA replacement enzyme, known as trans-splicing ribozyme, which can edit target RNA through simultaneous destruction and repair (and/or reprogramming) to yield the desired therapeutic RNA, thus, selectively inducing therapeutic gene activity in cells expressing the target RNA. For more information, please visit SOURCE Rznomics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究快速通道临床申请基因疗法

2024-10-15

·rznomics.com

Candidate for Rznomics Glioblastoma Treatment, Approved FDA Expanded Access Program

기사원문 Candidate for Rznomics Glioblastoma Treatment, Approved FDA Expanded Access Program Candidate for Rznomics Glioblastoma Treatment, Approved FDA Expanded Access Program Available to critically ill patients prior to authorization Expect to gain more patient data A gene therapy drug-based anticancer drug being developed by Rznomics can be used for humanitarian purposes to critically ill patients prior to approval. Rznomics announced on the 14th that its candidate "RZ-001" has been approved for sympathetic use (EAP) by the U.S. Food and Drug Administration (FDA). EAP refers to a system that provides humanitarian assistance to patients in critical condition for new drugs that are in the clinical trial stage prior to approval. RZ-001 can be used in patients with glioblastoma in critical condition thanks to this approval. Rznomics is conducting phase 1/2a clinical trial on patients with glioblastoma after obtaining approval for clinical plan (IND) from the Food and Drug Administration and the FDA. "We expect that we will be able to secure more patient data through this EAP," a company source said. RZ-001 was also designated as a fast track by the FDA in November last year. Glioblastoma is a carcinoma that occurs in the brain and has a survival period of less than a year in case of recurrence, which is a disease that has very high medical demand. On the other hand, it is considered a representative refractory tumor with insufficient treatment methods. "We plan to expand the target hospitals starting with Harvard University Hospital, reflecting the high interest of U.S. researchers in RZ-001's EAP," said Sung-woo Hong, vice president of Rznomics. "This program is expected to have positive results in terms of effectiveness as it can apply high-concentration test drugs immediately." Seong-wook Lee, CEO of Rznomics, said, "We hope that it will be a good treatment alternative for patients who are difficult to treat with existing drugs. We will do our best to get permission quickly through efficient clinical development."

快速通道临床申请基因疗法临床研究

2024-08-28

·rznomics.com

Rznomics gets approves U.S. FDA For anticancer Candidate Based On Gene Therapy

Rznomics gets approves U.S. FDA For anticancer Candidate Based On Gene Therapy Rznomics gets approves U.S. FDA For anticancer Candidate Based On Gene Therapy RZ001+T-Sentric + Avastin Approved Phase 1b/2a clinical trial for hepatocellular carcinoma patients Rznomics, a gene therapy drug-based anticancer drug developer, will start clinical trials in the United States that use its candidate and immune anticancer drugs in combination. Rznomics announced on the 19th that it has received approval from the U.S. Food and Drug Administration (FDA) for its phase 1b/2a clinical trial in which the anticancer drug candidate "RZ-001" and immuno-cancer drugs are combined. The plan is to evaluate both effectiveness and safety by co-administering RZ-001 together with the first standard treatment (Tscentrick + Avastin) to about 50 patients diagnosed with hepatocellular carcinoma. RZ-001 is an anticancer drug candidate that is being developed by applying the RNA editing platform technologies owned by Rznomics. It targets telomerase (hTERT) RNA, which is specifically expressed in cancer cells, by delivering RNA enzymes with adenovirus as a vector. Normal cells become shorter in telomeres, and when there is not much time left, they perceive themselves to be 'old' and die without further dividing. However, in cancer cells, telomerase, an enzyme that increases the length of telomeres that is decreasing again, is overactive, and telomeres may continue to lengthen. This is the cause of cancer cells continuing to divide without dying. RZ-001 removes hTERT RNA from hepatocytes that have become cancerous cells so that telomerase is not expressed. It induces apoptosis by making telomeres shorten normally. HSV-TK is also expressed at the cut hTERT site. Antiviral drugs (balgancyclover) administered with RZ-001 selectively attack only cancerous cells in response to this gene. It is a dual mechanism that removes the telomerase gene that causes infinite proliferation of cancer cells and inserts virus-derived genes to cause antiviral drugs to attack cancer cells. The FDA-approved clinical trial was combined with ticentric + avastin, which is the most widely used first-line treatment for hepatocellular carcinoma. If differentiated safety and efficacy are demonstrated compared to existing treatments, it could open the way for them to enter the largest market of first-line treatments. Rznomics plans to collaborate with large domestic and international pharmaceutical companies for this clinical trial. Among the clinical drugs, atetzolizumab has been contracted to receive supply from Roche and bevacizumab from Celltrion. Seong-wook Lee, CEO of Rznomics, said, "As many researchers and institutions cooperate in RZ-001 clinical development, we will do our best to succeed as an innovative anticancer drug."

临床研究临床申请基因疗法

100 项与 RZ-001 相关的药物交易

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