Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetic Characteristics of MIT-001 After Subcutaneous and Intravenous Administration in Healthy Subjects

1. Part 1 Randimization, Double blinded, Placebo controlled, Dose escalation(10mg, 20mg, 40mg) of MIT-001 SC or IV single administration to evaluate safety, tolerability and PK in healthy adult.
2. Part2 Randimization, Double blinded, Placebo controlled, MIT-001 SC multiple administration for 7days (20mg & 40mg) to evaluate safety, tolerability and PK in healthy adult.

开始日期2022-05-13

申办/合作机构

Mitoimmune Therapeutics, Inc.

KCT0006696

/ Completed临床2期

A Phase IIa, Multi-center, Dose-finding Clinical Trial to Evaluate the Safety, the Efficacy for Prevention of Oral Mucositis and the Pharmacokinetics of MIT-001 in Patients with Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplantation

开始日期2022-02-04

申办/合作机构

Mitoimmune Therapeutics, Inc.

NCT05493800

/ Active, not recruiting临床2期

A Phase IIa, Multi-center, Dose-finding Study to Evaluate Safety and Efficacy for Prevention of Oral Mucositis and PK of MIT-001 in Patients With Lymphoma or Multiple Myeloma Receiving Conditioning Chemotherapy Followed by Auto HSCT

Evaluate the efficacy and safety for the prevention of oral mucositis and PK of MIT-001 for lymphoma or multiple myeloma patients receiving conditioning chemotherapy for autologous hematopoietic stem cell transplantation(auto-HSCT).

开始日期2022-02-01

申办/合作机构

Mitoimmune Therapeutics, Inc.

100 项与 MIT-001 相关的临床结果

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100 项与 MIT-001 相关的转化医学

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100 项与 MIT-001 相关的专利（医药）

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项与 MIT-001 相关的文献（医药）

2024-04-01·Virus research

In vitro broad-spectrum antiviral activity of MIT-001, a mitochondria-targeted reactive oxygen species scavenger, against severe acute respiratory syndrome coronavirus 2 and multiple zoonotic viruses

Article

作者: Kim, Soon Ha ; Lee, Eun-Woo ; Yoo, Junsang ; Shin, Hye Jin ; Natasha, Augustine ; Kim, Won-Keun ; Shim, Hyun Soo ; Rajoriya, Shivani ; Lim, Taehun ; Im, Hyeonjoo ; Kim, Jong Woo ; Kim, Bohyeon

The COVID-19 pandemic caused by SARS-CoV-2 becomes a serious threat to global health and requires the development of effective antiviral therapies. Current therapies that target viral proteins have limited efficacy with side effects. In this study, we investigated the antiviral activity of MIT-001, a small molecule reactive oxygen species (ROS) scavenger targeting mitochondria, against SARS-CoV-2 and other zoonotic viruses in vitro. The antiviral activity of MIT-001 was quantified by RT-qPCR and plaque assay. We also evaluated the functional analysis of MIT-001 by JC-1 staining to measure mitochondrial depolarization, total RNA sequencing to investigate gene expression changes, and immunoblot to quantify protein expression levels. The results showed that MIT-001 effectively inhibited the replication of B.1.617.2 and BA.1 strains, Zika virus, Seoul virus, and Vaccinia virus. Treatment with MIT-001 restored the expression of heme oxygenase-1 (HMOX1) and NAD(P)H: quinone oxidoreductase 1 (NqO1) genes, anti-oxidant enzymes reduced by SARS-CoV-2, to normal levels. The presence of MIT-001 also alleviated mitochondrial depolarization caused by SARS-CoV-2 infection. These findings highlight the potential of MIT-001 as a broad-spectrum antiviral compound that targets for zoonotic RNA and DNA viruses, providing a promising therapeutic approach to combat viral infection.

2011-10-01·Molecular and cellular endocrinology2区 · 医学

The puzzles of the prokineticin 2 pathway in human reproduction

2区 · 医学

Review

作者: Cecilia Martin ; Lacey Plummer ; Yisrael Sidis ; Nelly Pitteloud ; Ravikumar Balasubramanian ; William F. Crowley ; Qun-Yong Zhou

Prokineticin, 1 (PROK1) and prokineticin 2 (PROK2), are two closely related proteins that were identified as the mammalian homologs of their two amphibian homologs, mamba intestinal toxin (MIT-1) and Bv8. MIT-1 was initially identified as a non-toxic constituent in the venom of the black mamba snake (Dendroaspis polylepis) (Joubert and Strydom, 1980) while Bv8 was identified in the skin secretion of the toad, Bombina variegate (Mollay et al., 1999). All three homologs stimulate gastrointestinal motility thus accounting for their family name "prokineticins" (Schweitz et al., 1990, 1999). However, since its initial description, both PROK1 and PROK2 have been found to regulate a dazzling array of biological functions throughout the body. In particular, PROK1 acts as a potent angiogenic mitogen on endocrine vascular epithelium, thus earning its other name, Endocrine gland-vascular endothelial factor (EG-VEGF) (LeCouter et al., 2002). In contrast, the PROK2 signaling pathway is a critical regulator of olfactory bulb morphogenesis and sexual maturation in mammals and this function is the focus of this review.

1999-11-19·FEBS letters3区 · 生物学

MIT₁, a black mamba toxin with a new and highly potent activity on intestinal contraction

3区 · 生物学

Article

作者: Moinier, D. ; Diochot, S. ; Lazdunski, M. ; Pacaud, P. ; Schweitz, H.

Mamba intestinal toxin (MIT1) isolated from Dendroaspis polylepis venom is a 81 amino acid polypeptide cross‐linked by five disulphide bridges. MIT1 has a very potent action on guinea‐pig intestinal contractility. MIT1 (1 nM) potently contracts longitudinal ileal muscle and distal colon, and this contraction is equivalent to that of 40 mM K+. Conversely MIT1 relaxes proximal colon again as potently as 40 mM K+. The MIT1‐induced effects are antagonised by tetrodotoxin (1 μM) in proximal and distal colon but not in longitudinal ileum. The MIT1‐induced relaxation of the proximal colon is reversibly inhibited by the NO synthase inhibitor L‐NAME (200 μM). 125I‐labelled MIT1 binds with a very high affinity to both ileum and brain membranes (Kd=1.3 pM and 0.9 pM, and Bmax=30 fmol/mg and 26 fmol/mg, respectively). MIT1 is a very highly selective toxin for a receptor present both in the CNS and in the smooth muscle and which might be an as yet unidentified K+ channel.

项与 MIT-001 相关的新闻（医药）

2021-04-06

·BioSpace

MitoImmune Received FDA Clearance of IND Application for MIT-001, a Novel Anti-Inflammatory/Anti-Necrotic Therapy for Oral Mucositis in CCRT patients with Head and Neck Cancer

- MitoImmune initiates a Phase 2 trial of oral mucositis (OM) prevention in the first half of 2021 in the US and Korea, and is expanding OM treatment into hematopoietic stem cell transplantation clinical trials SEOUL, South Korea, April 6, 2021 /PRNewswire/ -- MitoImmune Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for MIT-001, an innovative new drug candidate for the treatment of oral mucositis. MitoImmune plans to initiate a randomized, double–blind, placebo–controlled, multi–center trial in the first half of this year to evaluate the safety and efficacy of three different doses of MIT-001 compared to the placebo in prevention of OM in 60 patients with head and neck squamous cell carcinoma (HNSCC) who are undergoing concurrent chemoradiotherapy (CCRT) in the US and South Korea. CCRT as a standard therapy for the treatment of a number of cancers can cause various side effects during the patient's treatment process. One of the most serious side effects, oral mucositis, accompanied by intensive inflammation and necrosis in the oral cavity, leads to large restrictions on the patient's dietary intake, increases the risk of severe infection, and even acts as a serious obstacle to CCRT. The unmet medical needs in developed countries remain very high, but there is no effective medical treatment for oral mucositis. "We are very pleased to be advancing our therapy of anti-inflammatory and anti-necrotic agent based on the novel action mechanism of mitochondria-targeted reactive oxygen species (ROS) scavenger into the clinical development in our quest to bring an innovative, better treatment to the patients who need them," said Soon-Ha Kim, Ph.D., chief executive officer of MitoImmune. In addition to phase 2 clinical trial for the patients with HNSCC in the United States and Korea, Mitoimune has recently received the IND approval from the Ministry of Food and Drug Safety (MFDS) in Korea for a phase 2 clinical trial, to verify the safety and efficacy for OM in the lymphoma/ multiple myeloma patients with chemotherapy (CT) undergoing hematopoietic stem cell transplantation (HSCT). The first HSCT patient administration is planned for the 2nd quarter of this year. MIT-001 is a novel class of anti-inflammatory and anti-necrotic agent, specifically scavenging ROS in the mitochondria. This action mechanism of MIT-001 is expected to effectively suppress massive inflammation like oral mucositis occurring in the necrotic ulcers of oral mucous via removing excessive mitochondrial ROS, a major contributing factor in the CCRT-induced inflammation and necrosis. MitoImmune is a leading biotech company focusing on the development of mitochondrial therapeutics providing a breakthrough for life-threatening diseases based on its proprietary structural platform technology, which was scientifically verified through more than 40 published papers. MitoImmune is seeking to expand its R&D pipelines to chronic inflammatory disorders and neurodegenerative diseases. Homepage:

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100 项与 MIT-001 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
血液肿瘤	临床2期	美国	Mitoimmune Therapeutics, Inc.	2022-02-01
多发性骨髓瘤	临床2期	美国	Mitoimmune Therapeutics, Inc.	2022-02-01
局部晚期头颈部鳞状细胞癌	临床2期	美国	Mitoimmune Therapeutics, Inc.	2021-06-21
口腔炎	临床2期	美国	Mitoimmune Therapeutics, Inc.	2021-06-21

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2023	临床2期	口腔炎	16	MIT-001 5 mg	範簾醖遞衊鏇窪鹽鏇鏇(選鹹積窪積繭積觸餘獵) = 壓壓願製製鏇餘襯簾鑰鏇製鑰願餘願觸鏇鏇製 (鹽製網窪壓繭簾築願願 ) 更多	-	2023-12-09
				MIT-001 10 mg	範簾醖遞衊鏇窪鹽鏇鏇(選鹹積窪積繭積觸餘獵) = 餘遞窪憲鹽鑰鑰顧構鬱鏇製鑰願餘願觸鏇鏇製 (鹽製網窪壓繭簾築願願 ) 更多