DIAMYD FILES US IND FOR PHASE III TRIAL WITH DIABETES VACCINE
Press Release, Stockholm, Sweden, December 21, 2007 – Diamyd Medical AB (www.omxgroup.com, ticker: DIAM B; www.otcqx.com, ticker DMYDY)
Diamyd Medical announced today that it has filed an Investigational New Drug (IND) application for a pivotal US Phase III clinical trial with the Diamyd® therapeutic vaccine in recent onset type 1 diabetes patients. The application was submitted to the US Food and Drug Administration (FDA).
Similar applications for a parallel European Phase III trial are planned to be submitted to European regulatory agencies. Diamyd Medical anticipates that two successful Phase III studies, each comprising 300 recent onset type 1 diabetes patients, may lead to market approval.
The Diamyd® therapeutic vaccine is intended to arrest or slow down the autoimmune destruction of insulin producing beta cells in type 1 diabetes. Diamyd® has demonstrated significant efficacy in Phase II clinical trials in preservation of beta cell function for at least 21 months. Additionally, no treatment-related serious adverse events have been observed, providing Diamyd® with a strong safety profile.
“A newly diagnosed type 1 diabetes patient might face a lifetime of complications from the disease despite conventional therapy with insulin injections. In this context, Diamyd® has a remarkable potential as a novel therapy filling a desperately unmet medical need,” says Elisabeth Lindner, President and CEO of Diamyd Medical. “The filing of the Diamyd® IND and a receipt of approval thereafter are prerequisites for conducting confirmatory studies in larger patient populations in the US and important steps towards making the Diamyd®-vaccine available to the patients.”
“Preservation of beta cell function in type 1 diabetes patients is an important step towards finding a cure for type 1 diabetes and paving the way for beta cell regeneration, stem cell and transplantation therapies,” says Professor Jerry Palmer, Head of Diabetes Endocrinology Research Center at the University of Washington in Seattle, US, who will take the role as lead investigator in the planned US Phase III study. “Endogenous insulin production makes it easier for the patients to manage their disease and there should be less late-stage complications. I am proud to take Diamyd® to the next level.”
As previously announced, the Phase III trials will evaluate the effectiveness and safety of Diamyd® in patients that have had type 1 diabetes for up to three months. Based upon previous discussions with the FDA, meal-stimulated C-peptide, as a correlate for the patient’s own insulin production, will be the primary endpoint. Insulin requirement and glycemic endpoints will also be measured and results will be evaluated after 15 months.