tempol (MBM-02) / DMK Pharma, Matrix Biomed - LARVOL DELTA

Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients. (clinicaltrials.gov) - P2/3 | N=248 | Terminated | Sponsor: Adamis Pharmaceuticals Corporation | Recruiting ➔ Terminated; Study did not demonstrate statistical significance of its primary endpoint of clinical resolution of COVID-19 symptoms at day 14 versus placebo

Trial termination • Infectious Disease • Novel Coronavirus Disease

Treatment of Metastatic Cancer in Terminally Diagnosed Patients (clinicaltrials.gov) - P=N/A | N=N/A | Available | Sponsor: Matrix Biomed, Inc.

New trial • Oncology

Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients. (clinicaltrials.gov) - P2/3; N=248; Recruiting; Sponsor: Adamis Pharmaceuticals Corporation; Not yet recruiting ➔ Recruiting; Trial completion date: Jan 2022 ➔ Sep 2022; Trial primary completion date: Dec 2021 ➔ Jun 2022

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate the Effects of Tempol (MBM-02) in COVID-19 Patients. (clinicaltrials.gov) - P2/3; N=248; Not yet recruiting; Sponsor: Adamis Pharmaceuticals Corporation; Initiation date: May 2021 ➔ Aug 2021

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Adamis Sends Letter to Stockholders Regarding Its Strategic Focus on Tempol as a Potentially Potent Treatment for COVID-19 (Businesswire) - "The clinical members of the DSMB include Dr. Michael Ison...The purpose of the DSMB is to provide oversight and monitoring of the conduct of the clinical trial, and to ensure the safety of the participants and the validity and integrity of the study."

Media quote • Infectious Disease • Novel Coronavirus Disease

Adamis Provides Update on Clinical Trial Start-Up Progress for Tempol in the Treatment of COVID-19 (GlobeNewswire) - "Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that clinical trial start-up activities are underway for examining the effects of Tempol...Commenced activities include site identification and initiation, data base production, vendor management, and the establishment of an independent data safety monitoring board of infectious disease experts...Clinical trial drug product and placebo have also been obtained. The goal of the trial...is to examine the safety and activity of Tempol in COVID-19 patients early in the infection."

Trial status • Infectious Disease • Novel Coronavirus Disease

Adamis Highlights National Institute of Health Study Identifying Tempol as a Potential Antiviral Drug for COVID-19 (GlobeNewswire) - "According to a study of cell cultures conducted by NIH researchers, Tempol demonstrated an ability to limit SARS-CoV-2 infection by impairing the activity of a viral enzyme known as RNA replicase. The NIH researchers also found that Tempol 'doses used in their antiviral studies could be likely achieved in tissues that are the primary targets for the virus'....The NIH study follows studies conducted in collaboration with Galveston National Laboratory and the University of Texas Medical Branch at Galveston....The TEMPOL-treated animals showed decreased lung inflammation compared to controls....Results from the NIH study also support the design and implementation of the protocol in Adamis’ Investigational New Drug Application to study Tempol in early COVID-19 infection."

Preclinical • Infectious Disease • Novel Coronavirus Disease

MBM-02 (Tempol) for the Treatment of Glioblastoma Multiforme (GBM) (clinicaltrials.gov) - P2; N=55; Not yet recruiting; Sponsor: Matrix Biomed, Inc.

Clinical • New P2 trial • Brain Cancer • Glioblastoma • Neutropenia • Oncology • Solid Tumor

MBM-02 (Tempol) for the Treatment of Biochemical Recurrent Prostate Cancer (clinicaltrials.gov) - P2; N=55; Not yet recruiting; Sponsor: Matrix Biomed, Inc.

Clinical • New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Adamis Pharmaceuticals Announces IND Submission to FDA for Tempol for the Treatment of COVID-19 (GlobeNewswire) - "Adamis Pharmaceuticals Corporation...announced today the submission of an Investigational New Drug (IND) to FDA for the investigational use of Tempol for the treatment of Coronavirus (COVID-19). The submission of the IND to FDA followed a Pre-IND meeting with FDA...The Company plans to seek government and/or non-government funding to study the treatment and prevention of COVID-19 with Tempol....In animal models, Tempol has been shown to decrease proinflammatory cytokines (cytokine storm), and through its potent antioxidant activity has been shown to decrease the harmful effects of ROS. In addition, Tempol has been shown to decrease platelet aggregation..."

Cytokine storm • IND • Preclinical • Infectious Disease • Novel Coronavirus Disease

Adamis Pharmaceuticals Announces 2020 Financial Results and Business Update (GlobeNewswire) - "'We also intend to commence our Phase 2/3 clinical trial for Tempol in the second quarter of this year, to evaluate the use of Tempol for the prevention of hospitalization of patients with COVID-19.'"

Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Adamis Pharmaceuticals Announces Tempol Reduces Lung Inflammation in the COVID-19 Challenged Hamster Model (GlobeNewswire) - "...in studies conducted at Galveston National Laboratory (GNL), University of Texas Medical Branch (UTMB) at Galveston, hamsters challenged with the virus that causes COVID-19 (SARS-CoV-2), resulted in decreased inflammation in the lungs of animals treated with Tempol compared to controls. This is the first data demonstrating that Tempol, a novel antioxidant, can reduce inflammation in animals given the virus (SARS-CoV-2) that causes COVID-19....Tempol has now been shown to: (1) Decrease the proinflammatory cytokines (cytokine storm) in animal models (lipopolysaccharide induced), (2) Suppress cytokines in stimulated COVID-19 positive human cells, and (3) Reduce inflammation in hamsters challenged with COVID-19."

Cytokine storm • Preclinical • Infectious Disease • Novel Coronavirus Disease

Adamis Pharmaceuticals Cleared to Proceed with Human Studies of Tempol for the Treatment of COVID-19 (GlobeNewswire) - "...U.S. Food and Drug Administration ('FDA') has completed the safety review of the Company’s Investigational New Drug ('IND') application and has concluded that Adamis may proceed with the proposed clinical investigation of Tempol for the treatment of COVID-19....'If this trial is successful, we would likely petition the FDA to consider Emergency Use Authorization for Tempol as a therapeutic treatment for COVID-19'."

Cytokine storm • IND • Infectious Disease • Novel Coronavirus Disease

Study to Evaluate Tempol (MBM-02) to Help Prevent Hospitalizations in COVID-19 Patients. (clinicaltrials.gov) - P2/3; N=310; Not yet recruiting; Sponsor: Adamis Pharmaceuticals Corporation

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

Adamis Pharmaceuticals and Human Immune Monitoring Center at Stanford University Announce Preliminary Tempol Data in Cells from COVID-19 Patients (GlobeNewswire) - P=NA, N=NA; "Adamis Pharmaceuticals Corporation...conducted a study to investigate the effects of Tempol on immune cells from COVID-19 patients. Preliminary data from that study shows that Tempol decreases cytokines from stimulated cells from COVID-19 patients....'This is the first data that we know of that shows Tempol has a positive impact in decreasing cytokine production from COVID-19 positive patient cells. These data further support the need for clinical studies of Tempol in COVID-19 patients.'"

Clinical data • Cytokine storm • Infectious Disease • Novel Coronavirus Disease