Date: 2014-10-21
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in the Journal of Diabetes Science and Technology
Company: Kamada (Israel)
Product: Glassia® (alpha-1 antitrypsin)
Action
mechanism: protein. Glassia® (Alpha1-Proteinase Inhibitor -Human) is the first available ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with alpha-1 antitrypsin (AAT) deficiency. Glassia is administered once a week to augment the levels of AAT in the blood to normal values. AAT is a protein derived from human plasma with known and newly discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue protective and antimicrobial properties. Glassia® is approved by the FDA for the treatment of AAT deficiency. It is marketed through a strategic partnership with Baxter in the United States.
Disease: type 1 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial details:
Latest
news: * On October 21, 2014, Kamada, a plasma-derived protein therapeutics company focused on orphan indications, announced that a comprehensive review of the data available in the literature in support of the mechanism of action of Alpha-1 Antitrypsin (AAT) for the treatment of Type-1 Diabetes, was published in the August 2014 edition of the peer-reviewed, Journal of Diabetes Science and Technology. The online version of the review article, titled, “Mechanistic Evidence in Support of Alpha-1 Antitrypsin as a Therapeutic Approach for Type-1 Diabetes” can be accessed at:http://dst.sagepub.com/content/early/2014/08/23/1932296814547096. “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.”
“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 ? 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.”
About Glassia
