GAD65

US Partial Clinical Hold on Diamyd® Phase III Trial Lifted by the FDA

Retrieved on: 
Monday, November 28, 2022
Vitamin D, Diamyd Medical, Insulin, Haplotype, Regeneration, Food, HLA, Type 1 diabetes, Artificial intelligence, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, C-peptide, Hypoglycemia, Phase, FDA, Glycated hemoglobin, GAD65, Meta-analysis, Genta (company), Precision medicine, Ageing, Uppsala University Hospital, Safety, Probability, Pharmaceutical industry

STOCKHOLM, Nov. 28, 2022 /PRNewswire/ --Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision medicine and antigen-specific immunotherapy Diamyd in individuals recently diagnosed with type 1 diabetes.

Key Points: 
  • STOCKHOLM, Nov. 28, 2022 /PRNewswire/ --Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision medicine and antigen-specific immunotherapy Diamyd in individuals recently diagnosed with type 1 diabetes.
  • The FDA issued a partial clinical hold on the pivotal DIAGNODE-3 trial in September 2021, pausing the start of the trial in the US.
  • Diamyd Medical will immediately resume the process of interacting with clinical sites and institutional review boards with the aim of including US clinical sites in the trial.
  • DIAGNODE-3, a confirmatory Phase III trial is actively recruting patients with recent-onset Type 1 Diabetes in eight European countries.

US Partial Clinical Hold on Diamyd® Phase III Trial Lifted by the FDA

Retrieved on: 
Monday, November 28, 2022
Vitamin D, Diamyd Medical, Insulin, Haplotype, Regeneration, Food, HLA, Type 1 diabetes, Artificial intelligence, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, C-peptide, Hypoglycemia, Phase, FDA, Glycated hemoglobin, GAD65, Meta-analysis, Genta (company), Precision medicine, Ageing, Uppsala University Hospital, Safety, Probability, Pharmaceutical industry

STOCKHOLM, Nov. 28, 2022 /PRNewswire/ --Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision medicine and antigen-specific immunotherapy Diamyd in individuals recently diagnosed with type 1 diabetes.

Key Points: 
  • STOCKHOLM, Nov. 28, 2022 /PRNewswire/ --Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision medicine and antigen-specific immunotherapy Diamyd in individuals recently diagnosed with type 1 diabetes.
  • The FDA issued a partial clinical hold on the pivotal DIAGNODE-3 trial in September 2021, pausing the start of the trial in the US.
  • Diamyd Medical will immediately resume the process of interacting with clinical sites and institutional review boards with the aim of including US clinical sites in the trial.
  • DIAGNODE-3, a confirmatory Phase III trial is actively recruting patients with recent-onset Type 1 Diabetes in eight European countries.

A new analysis that supports the effect of the diabetes vaccine Diamyd® will be presented at a scientific conference on 13 October

Retrieved on: 
Thursday, September 23, 2021
ISPAD, Clinical trial, Diamyd Medical, International Society for Pediatric and Adolescent Diabetes, Hyperglycemia, GAD65, Society, Hannelius, ASHG, Diabetes, Patient, Type 1, Glycated hemoglobin, Eli Lilly and Company, Pediatrics, Continuous glucose monitor, International Society of Sculptors, Painters and Gravers, CEO, Blood, Meta-analysis, Company, Adolescence, Congress, Uppsala University Hospital, Human genetics, CGM, Hypoglycemia, Insulin, IIB, HLA, Nasdaq, EASD, Regeneration, Pharmaceutical industry

The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.

Key Points: 
  • The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.
  • Complete results will be submitted for publication in a scientific journal later this year.
  • The diabetes vaccine Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production.
  • A vaccine manufacturing facility is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd.

A new analysis that supports the effect of the diabetes vaccine Diamyd® will be presented at a scientific conference on 13 October

Retrieved on: 
Thursday, September 23, 2021
ISPAD, Clinical trial, Diamyd Medical, International Society for Pediatric and Adolescent Diabetes, Hyperglycemia, GAD65, Society, Hannelius, ASHG, Diabetes, Patient, Type 1, Glycated hemoglobin, Eli Lilly and Company, Pediatrics, Continuous glucose monitor, International Society of Sculptors, Painters and Gravers, CEO, Blood, Meta-analysis, Company, Adolescence, Congress, Uppsala University Hospital, Human genetics, CGM, Hypoglycemia, Insulin, IIB, HLA, Nasdaq, EASD, Regeneration, Pharmaceutical industry

The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.

Key Points: 
  • The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.
  • Complete results will be submitted for publication in a scientific journal later this year.
  • The diabetes vaccine Diamyd is an antigen-specific immunotherapy for the preservation of endogenous insulin production.
  • A vaccine manufacturing facility is being set up in Ume for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd.