Kamada, announced positive preliminary interim results from a Phase I/II clinical trial of D1-AAT, which includes the Alpha 1 protein, for the treatment of type 1 diabetes. D1-AAT may slow the progression of the type 1 diabetes, and may greatly reduce or eliminate, the need for insulin. This would stabilize the condition of diabetics and/or reduce or prevent serious complications of the disease. D1-AAT was approved orphan drug status for the treatment of type 1 diabetes by the FDA in 2011.
The trial found stabilization and even improvement in diabetes measures of the patients, and a high safety profile in the 20 children and adolescents tested. Kamada cautions, however, that the trial was limited in time and that the patient sample was small. These facts should be taken into account when drawing conclusions from the interim report.
The interim report includes data collected in the ten months since the start of clinical trial in June 2011, during the three months of continuous treatment of the children and adolescents who had recently developed type 1 diabetes.
The company expects to publish the final report on the clinical trial in late 2012.
Kamada is conducting the clinical trial at Schneider Children’s Hospital and Assaf Harofeh Hospital in Israel.