Ganite (gallium nitrate) / Seattle Children's Hospital, University of Washington, Cystic Fibrosis Foundation, Genta - LARVOL DELTA

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Chris Goss | Trial completion date: Jun 2025 ➔ Mar 2027 | Trial primary completion date: Jun 2025 ➔ Mar 2027

Trial completion date • Trial primary completion date • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

IV Gallium Study for Patients with Cystic Fibrosis Who Have NTM (ABATE Study) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Chris Goss | Trial primary completion date: Sep 2024 ➔ Jun 2025

Trial primary completion date • Cystic Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Do Cannabis Users Require More Anesthesia During Third Molar Removal Under Intravenous General Anesthesia When Compared to Non-Users? (AAOMS 2024) - "Secondary outcome variables included mg of midazolam, micrograms (mcg) of fentanyl, mg bolus of propofol, propofol infusion (mg/kg/min), and mg of ketamine. The results suggest that CUs require 55% more total propofol and increased procedure time in CU compared to NCU during IVGA for M3 removal. This study is the first to propose specific questions for identifying high-risk cannabis users undergoing IVGA, with our findings suggesting critical cutoffs for duration exceeding 2-3 years and a frequency of multiple daily use."

Addiction (Opioid and Alcohol) • Anesthesia

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Chris Goss | Phase classification: P1b ➔ P1 | Trial primary completion date: Sep 2023 ➔ Sep 2024

Nontuberculous mycobacteria • Phase classification • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (clinicaltrials.gov) - P1b | N=40 | Recruiting | Sponsor: Chris Goss | Trial completion date: Sep 2024 ➔ Jun 2025

Nontuberculous mycobacteria • Trial completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

Modifying Macrophage Phenotypes to Dampen Airway Inflammation in Chronic Lung Diseases (ATS 2022) - "Daily maintenance azithromycin, which can slow lung function decline and decrease frequency of exacerbations in the people with cystic fibrosis (PwCF), is being studied in other chronic airways diseases and is thought to exert its effects by modulating immune cell phenotypes...Gallium nitrate is being evaluated as an antimicrobial therapy for chronic infections in PwCF... Gallium altered macrophage responses to TLR agonists in vitro, and in vivo reduced inflammation and altered macrophage gene and surface receptor expression following ALI. These data suggest that gallium shifts lung macrophages to less inflammatory phenotypes, and has the potential to provide immune modulation to prevent excessive deleterious inflammation people with chronic airways diseases."

Acute Lung Injury • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immune Modulation • Immunology • Infectious Disease • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • CXCL13 • IFNG • IL6 • ITGAM

[VIRTUAL] Modifying macrophage phenotypes to dampen nonresolving CF airway inflammation: Gallium nitrate as the next azithromycin? (NACFC-I 2021) - "Gallium altered macrophage responses to inflammatory stimuli in vitro and reduced markers of inflammation and altered macrophage gene expression and surface markers in vivo. These data suggest that gallium shifts lung macrophages to less-inflammatory phenotypes. Studies are ongoing to further characterize gallium’s effects on macrophage subsets in vivo and to identify the mechanism by which gallium alters transcriptional responses."

Acute Lung Injury • Immunology • Infectious Disease • Inflammation • Non‐Cystic Fibrosis Bronchiectasis • Nontuberculous Mycobacterial Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • CXCL13 • IL6 • ITGAM

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Chris Goss; Trial completion date: Apr 2023 ➔ Sep 2024; Trial primary completion date: Dec 2022 ➔ Sep 2023

Clinical • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) (clinicaltrials.gov) - P1b; N=40; Recruiting; Sponsor: Chris Goss; Not yet recruiting ➔ Recruiting; Initiation date: May 2020 ➔ Feb 2021

Clinical • Enrollment open • Trial initiation date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

FDA awards six grants to fund new clinical trials to advance the development of medical products for the treatment of rare diseases (FDA) - "Today, the U.S. Food and Drug Administration announced that it has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years....Seattle Children's Hospital (Seattle, Washington), Christopher Goss, phase 1b study of IV gallium nitrate for the treatment of cystic fibrosis patients colonized with nontuberculosis mycobacterium – $3 million over four years."

Grant • Cystic Fibrosis • Nontuberculous Mycobacterial Disease