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Targeting memory T-cells in Type 1 diabetes
Date:9/22/2013

WA, Seattle (September 23, 2013) Encouraging results from the T1DAL study (Targeting effector memory T cells with alefacept in new onset type 1 diabetes), led by Mark R. Rigby M.D., Ph.D. from Indiana University and Riley Hospital for Children in Indianapolis and sponsored by the Immune Tolerance Network (ITN) with additional support from JDRF, are published today in The Lancet Diabetes & Endocrinology.

Alefacept, an engineered fusion protein targeting a surface molecule, CD2, found on T-lymphocytes, was the first biologic therapy approved for moderate to severe plaque psoriasis. By binding CD2, alefacept inhibits co-stimulation and induces T-cell depletion. T-cell mediated destruction of insulin producing pancreatic beta cells is a central feature of Type 1 diabetes, but targeting of CD2 has not previously been evaluated in this disease. The T1DAL trial was designed to test whether alefacept would preserve pancreatic beta cell function in newly diagnosed patients.

The Phase II T1DAL study enrolled 49 new-onset type 1 diabetic subjects, ages 12 to 35, who were randomized into two groups: 33 to alefacept and 16 to placebo. Patients received two twelve week courses (separated by a 12 week pause) of either alefacept or placebo. Twelve months from the start of the study, patients underwent a mixed meal tolerance test to measure the C-peptide response (a measure of insulin production). The primary endpoint, a 2-hour C-peptide response, did not show statistically significant differences between treatment and placebo groups; however, a secondary endpoint, a 4-hour C-peptide response, was significantly higher at 12 months in the treatment group compared to the placebo group. Other secondary endpoints including insulin use and rate of hypoglycemic events were significantly lower at 12 months in the alefacept treated group.

Although the primary endpoint was not met, these encouraging results of key secondary endpoints suggest a dise
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Contact: Philip Bernstein, Ph.D.
ITNCommunications@immunetolerance.org
240-235-6132
Immune Tolerance Network
Source:Eurekalert

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