MIT-001 / MitoImmune Therap, LG Chem - LARVOL DELTA

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: MitoImmune Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Head and Neck Cancer • Mucositis • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Stomatitis

Discovery of New Phenyltetrazolium Derivatives as Ferroptosis Inhibitors for Treating Ischemic Stroke: An Example Development from Free Radical Scavengers. (PubMed, J Med Chem) - "Further screening based on this strategy identified NecroX-7 and Eriodictyol-7-O-glucoside as novel ferroptosis inhibitors with highly polar structural characteristics. This approach bridges the gap between free radical scavengers and ferroptosis inhibitors, providing a foundation for research and insights into novel ferroptosis inhibitor development."

Journal • Cardiovascular • Ischemic stroke

Capella: Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: MitoImmune Therapeutics | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2 | Trial completion date: Apr 2024 ➔ Dec 2024 | Trial primary completion date: Oct 2023 ➔ Jun 2024

Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Lymphoma • Mucositis • Multiple Myeloma • Oncology • Stomatitis • CD34

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. (PubMed, Virus Res) - "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."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • HMOX1 • NQO1

Evaluation of the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT (ASH 2023) - "MIT-001 was administered intravenously for 30 minutes once daily before conditioning chemotherapy for four to nine days, depending on the conditioning regimens including high-dose melphalan and BMT (intravenous busulfan, melphalan, thiotepa) for auto-HSCT. The phase IIa part 1 results strongly suggest the therapeutic potential of MIT-001 to prevent severe OM in the patients with lymphoma and MM undergoing melphalan-containing conditioning followed by auto-HSCT."

Clinical • Bone Marrow Transplantation • Hematological Malignancies • Lymphoma • Mucositis • Multiple Myeloma • Oncology • Pain • Stomatitis • Transplantation

Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC Administration in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: MitoImmune Therapeutics | Active, not recruiting ➔ Completed

Trial completion

Alleviation of hippocampal necroptosis and neuroinflammation by NecroX-7 treatment after acute seizures. (PubMed, Front Pharmacol) - "Thus, we investigated the therapeutic effects of a novel small molecule, NecroX-7, in TLE using both a low [Mg]-induced epileptiform activity model and a mouse model of pilocarpine-induced status epilepticus (SE)...Finally, western blot analysis demonstrated that NecroX-7 post-treatment after acute seizures could decrease the expression of mixed lineage kinase domain-like pseudokinase (MLKL) and phosphorylated MLKL (p-MLKL), markers for necroptosis. Taken all together, NecroX-7 has potential as a novel medication for TLE with its neuroprotective, anti-inflammatory, and anti-necroptotic effects."

Journal • CNS Disorders • Epilepsy • Inflammation • GFAP

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: MitoImmune Therapeutics | Trial completion date: Sep 2023 ➔ Dec 2024 | Trial primary completion date: Sep 2022 ➔ Apr 2024

Metastases • Trial completion date • Trial primary completion date • Head and Neck Cancer • Mucositis • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Stomatitis

Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC Administration in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: MitoImmune Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed

The Effect of Necrosis Inhibitor on Dextran Sulfate Sodium Induced Chronic Colitis Model in Mice. (PubMed, Pharmaceutics) - "Overall, the NI improved DSS induced chronic colitis by attenuating the mRNA expression of pro-inflammatory cytokines such as TNF-α. Therefore, NI use is a potential, novel treatment approach for IBD."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • HMGB1 • NF-κβ • TNFA

Capella: Evaluate the Safety and Efficacy for Oral Mucositis Prevention of MIT-001 in Auto HSCT (clinicaltrials.gov) - P2a | N=75 | Recruiting | Sponsor: MitoImmune Therapeutics

New P2a trial • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Lymphoma • Mucositis • Multiple Myeloma • Oncology • Stomatitis • CD34

Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC and IV Administration in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: MitoImmune Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

Clinical Trial to Evaluate Pharmacokinetic Characteristics of MIT-001 After SC and IV Administration in Healthy Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: MitoImmune Therapeutics

New P1 trial

MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: MitoImmune Therapeutics; Not yet recruiting ➔ Recruiting; Trial completion date: Apr 2023 ➔ Sep 2023; Trial primary completion date: May 2022 ➔ Sep 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Head and Neck Cancer • Mucositis • Oncology • Oral Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Stomatitis

MIT-001 Restores Human Placenta-Derived Mesenchymal Stem Cells by Enhancing Mitochondrial Quiescence and Cytoskeletal Organization. (PubMed, Int J Mol Sci) - "In conclusion, while TNF-α/IFN-γ-exposed MSCs lost homeostasis and mitochondrial quiescence by becoming over-activated in response to inflammatory cytokines, MIT-001 was able to rescue mitochondrial features and cellular phenotypes. Therefore, MIT-001 has therapeutic potential for clinical applications to treat mitochondrion-related inflammatory diseases."

Journal • Immune Modulation • Immunology • Inflammation • Metabolic Disorders • IFNG • TNFA

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 (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...for the treatment of oral mucositis...phase 2 clinical trial for the patients with HNSCC in the United States and Korea...The first HSCT patient administration is planned for the 2nd quarter of this year."

IND • New P2 trial • Head and Neck Cancer • Mucositis • Oncology • Squamous Cell Carcinoma of Head and Neck