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March 5, 2014
07:14 EDTKMDAKamada initiates Glassia Phase 2/3 clinical trial
Kamada announced the initiation of a Phase 2/3 clinical trial of Glassia. This double-blind, placebo-controlled, multicenter Phase 2/3 clinical trial of 190 pediatric patients with newly diagnosed T1D will evaluate the safety and efficacy of intravenous Glassia to halt disease progression and maintain the ability of the pancreas to produce insulin. This two-year study follows U.S. Food and Drug Administration and European Medicines Agency guidelines for clinical trials evaluating beta cell preservation and will measure C-peptide parameters HbA1C, hypoglycemic events and insulin daily dose, among others. Interim data are expected after approximately 90 patients complete one year of treatment, which will be in approximately two years. Initially, the trial will be conducted at four pediatric T1D medical centers in Israel with plans to expand the scope of the trial to include centers in other countries. Kamada previously reported positive preliminary data from the extension portion of its Phase 1/2 clinical trial of Glassia. That preliminary data showed that at approximately 20 months from diagnosis and approximately 10 months following the last Glassia infusion, 60% of study subjects who participated in the extension portion of the trial had peak C-peptide levels greater than 0.2 pmol/ml, which indicates a functioning beta cell capacity and is considered to be a higher percentage than would be expected without intervention.
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November 12, 2014
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07:10 EDTKMDAKamada reports Q3 EPS (9c), consensus (4c)
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