Additional phase I/II results show continued safety of NBI-6024 in adolescents.(Brief Article)

2002 JUL 17 - (NewsRx.com & NewsRx.net) -- Neurocrine Biosciences, Inc., (NBIX) announced that all doses of NBI-6024 were well tolerated when administered subcutaneously in adolescent patients with type I diabetes, at the 62nd annual meeting of the American Diabetes Association (ADA) in San Francisco. NBI-6024, which Neurocrine is developing in collaboration with Taisho Pharmaceutical Co., Ltd., is a therapeutic vaccine developed using Neurocrine's Altered Peptide Ligand (APL) technology. The authors concluded that these safety findings support the expanded investigation of NBI-6024.

This phase I/II trial was conducted in 35 adolescent patients ages 12-17 years with insulin-dependent type I diabetes to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of NBI-6024. The trial was a multicenter, randomized, double-blind, placebo-controlled, multidose, dose escalating study. Three cohorts received three dose levels of NBI-6024 or placebo biweekly over a period of 8 weeks for a total of 5 doses. Two additional cohorts received two dose levels of NBI-6024 or placebo biweekly and monthly for a total of 5 doses over a 12-week period. Overall the safety profile and incidence of adverse events for all dosing cohorts was similar to that of placebo. In addition, there were no detectable anti-6024 antibodies following single and multiple dose administration. No significant increase in anti-insulin, anti-GAD, and anti-ICA 512 levels relative to placebo was observed and cell mediated immune response was also not affected.

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