October 21, 2014
“The scientific rationale for Glassia to treat T1D is based on the anti-inflammatory and immunoregulatory activities that AAT holds, which support beta-cells recovery processes from autoimmuno-mediated tissue injury. Past studies have shown that despite having normal serum levels, the AAT of diabetic patients is inactive in this respect, and therefore, unable to cope with the developing inflammation in the beta cells,” noted Pnina Strauss, Kamada’s Vice President of Clinical Development and Intellectual Property. “Additionally, a number of recent studies support the rationale for treating T1D early in the disease diagnosis or the ‘honeymoon’ period, during which a critical mass of functional beta cells exists. It is hypothesized that Glassia may halt pancreatic inflammation, thereby allowing the survival of active and operating beta cells that secrete insulin, a survival which may allow the patient to reduce dependence on external insulin and eventually decrease disease complications.”
According to the study authors, “Protection of islets by AAT is consistent across multiple diabetes models. Findings from multiple experimental animal models provide clear evidence that AAT possesses broad anti-inflammatory and immune-regulatory activities, promoting tissue recovery processes in the context of immune-mediated ß cell destruction. The beneficial effect of AAT on diabetes was first demonstrated using virus-mediated gene delivery of AAT to non-obese diabetic (NOD) mice.1”
“This is an important publication because it provides insight into the underlying mechanism of action in support of the use of AAT to treat type-1 diabetes. Moreover, it provides the scientific rationale that corroborates the positive clinical results achieved in our Phase 1b clinical study and validates our continued clinical studies in this serious and life-threatening autoimmune disease,” stated David Tsur, co-Founder and Chief Executive Officer of Kamada. “We continue to enroll patients in our ongoing Phase 2/3 clinical trial. We are very excited about this opportunity as we believe Glassia can be a groundbreaking treatment for newly-diagnosed type 1 diabetes in pediatric patients as it should demonstrate the ability to halt disease progression and allow the pancreas to produce its own insulin.”