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Bayhill Therapeutics and the Juvenile Diabetes Research Foundation announce research collaboration
Date:10/30/2008

itive and the announcement of top-line results is expected in the second half of 2009.

Clinical Trial Results to Date

In the BHT-3021 phase I/II clinical trial, 44 patients have thus far been randomized to four different dose cohorts of BHT-3021 (0.3 mg, 1 mg, 3 mg, or 6 mg). BHT-3021 has demonstrated safety and tolerability, with no increase in adverse events relative to placebo. Preliminary data from the 1 mg dose cohort indicate that treatment with BHT-3021 may cause beta cell preservation as well as the induction of immune tolerance to pancreatic autoantigens. Clinical Trial Criteria

Key inclusion criteria for this trial include: a diagnosis of type 1a diabetes mellitus based on ADA criteria, ≤5 years since T1D was diagnosed, ≥ 18 years of age, ≤ 40 years of age at the time of diagnosis of Type 1 diabetes, detectable fasting C-peptide level, C-peptide increase during screening mixed meal tolerance test, and presence of antibodies to at least one beta cell antigen (insulin, GAD-65, or IA-2). ClinicalTrials.gov Identifier: NCT00453375.


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Contact: Leslie Schwartz
lschwartz@jdrf.org
212-479-7553
Juvenile Diabetes Research Foundation International
Source:Eurekalert

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