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

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.
Part2 Randimization, Double blinded, Placebo controlled, MIT-001 SC multiple administration for 7days (20mg & 40mg) to evaluate safety, tolerability and PK in healthy adult.

Start Date13 May 2022

Sponsor / Collaborator

Mitoimmune Therapeutics, Inc.Startup

KCT0006696 / RecruitingPhase 1/2

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

Start Date11 Feb 2022

Sponsor / Collaborator

Mitoimmune Therapeutics, Inc.Startup

NCT05493800 / Active, not recruitingPhase 2

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).

Start Date01 Feb 2022

Sponsor / Collaborator

Mitoimmune Therapeutics, Inc.Startup

100 Clinical Results associated with MIT-001

100 Translational Medicine associated with MIT-001

100 Patents (Medical) associated with MIT-001

Literatures (Medical) associated with MIT-001

01 Apr 2024·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

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

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.

13 Oct 2023·International journal of molecular sciences

Mitigating Age-Related Ovarian Dysfunction with the Anti-Inflammatory Agent MIT-001.

Article

Author: Kim, Yu Jin ; Lee, Jae Ho ; Cho, Min Jeong ; Kim, Soon Ha ; Koo, Yun Dong ; Jang, JuYi ; Kang, Min-Hee

Ovarian aging is a major obstacle in assisted reproductive medicine because it leads to ovarian dysfunction in women of advanced age. Currently, there are no effective treatments to cure age-related ovarian dysfunction. In this study, we investigated the effect of MIT-001 on the function of aged ovaries. Young and old mice were utilized in this study. MIT-001 was intraperitoneally administered, and the number of follicles and oocytes was analyzed. Each group was then retrieved for RNA and protein isolation. Total RNA was subjected to mRNA next-generation sequencing. Protein extracts from ovarian lysates were used to evaluate various cytokine levels in the ovaries. MIT-001 enhanced follicles and the number of oocytes were compared with non-treated old mice. MIT-001 downregulated immune response-related transcripts and cytokines in the ovaries of old mice. MIT-001 modulates the immune complex responsible for generating inflammatory signals and has the potential to restore the function of old ovaries and improve female fertility.

01 Oct 2011·Molecular and Cellular EndocrinologyQ2 · MEDICINE

The puzzles of the prokineticin 2 pathway in human reproduction

Q2 · MEDICINE

Review

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

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.

News (Medical) associated with MIT-001

06 Apr 2021

·www.biospace.com

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:

Collaborate

100 Deals associated with MIT-001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	Phase 2	KR	Mitoimmune Therapeutics, Inc.Startup	01 Feb 2022
Squamous Cell Carcinoma of Head and Neck	Phase 2	KR	Mitoimmune Therapeutics, Inc.Startup	21 Jun 2021
Squamous Cell Carcinoma of Head and Neck	Phase 2	US	Mitoimmune Therapeutics, Inc.Startup	21 Jun 2021
Stomatitis	Phase 2	KR	Mitoimmune Therapeutics, Inc.Startup	21 Jun 2021
Stomatitis	Phase 2	US	Mitoimmune Therapeutics, Inc.Startup	21 Jun 2021

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2023	Phase 2	Stomatitis	16	MIT-001 5 mg	jipgjybxhz(zeqqhxkctr) = igjwqaxlpz jacmyllyds (sjttyywzes ) View more	-	09 Dec 2023
				MIT-001 10 mg	jipgjybxhz(zeqqhxkctr) = juiklvgnjm jacmyllyds (sjttyywzes ) View more

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