Kamada announces new data from Glassia Phase I/II study in pediatric patients with type 1 diabetes

Oct 31 2013

Kamada Ltd. (Nasdaq and TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today reported preliminary data from the Company's ongoing extension study of a Phase I/II clinical trial with its lead product Glassia® to treat pediatric patients with a recently diagnosed type 1 diabetes (T1D).

In T1D endogenous insulin production is compromised, and with time progressive deterioration of beta-cell reserve occurs due to the continuous autoimmune attack. New interim data from the ongoing extension study showed that at ~20 months from T1D diagnosis and ~10 months following the last Glassia infusion, 60% of study subjects who participated (12/20) in the extension portion of the Phase I/II trial had peak C-peptide levels greater than 0.2 pmol/ml (average >0.4 pmol/ml), which indicates a functioning beta cell capacity and is a higher percentage than expected without intervention.

In addition, patients continued to attain ISPAD (International Society for Pediatric and Adolescent Diabetes) treatment targets with an average HbA1C of 7.5%, and the majority of patients (75%) presented HbA1C levels even lower than 7.5%, which is the clinically desired level for glycemic control in pediatric diabetic patients who usually demonstrate a more severe or volatile form of T1D disease compared with adults.

No safety issues were reported.

David Tsur, CEO of Kamada, stated, "We are delighted that these interim data from the extension study continue to demonstrate the positive signals seen in our analysis of study results. These positive data may potentially represent a breakthrough in the treatment of this disease, and encourage us to actively move forward with plans to advance the clinical development of Glassia in this indication. Importantly, the preservation of beta cells may allow patients to reduce dependence on external insulin and eventually decrease disease complications such as cardiovascular disease, kidney failure, eye disease, severe wounds and more. These complications remain an unmet need that is still inadequately answered with existing therapies, which include insulin, diet and behavioral treatment. Moreover, these complications have direct correlation with the extent of glycemic control the patient reaches during early disease phases. These complications compromise the patient's normal life routine, require considerable healthcare resources, have economic impact on the general work capacity of the diabetic employees and reduce their life expectancy."

Kamada plans to initiate a Phase II/III trial with Glassia with newly diagnosed T1D pediatric and young adult patients. The goal of the double-blind, placebo-controlled, multicenter study is to assess the efficacy of Glassia in treatment of new onset type 1 diabetes, as expressed by beta cell function and glycemic control. The clinical study will initiate in Israel, with potential plans to expand the scope to include other countries. The two-year study will randomize approximately 190 patients and will measure C-peptide parameters, HbA1C levels, hypoglycemic events, insulin daily dose and other diabetes-related analytes, as well as safety and tolerability parameters.