Dose optimization data from Tolerx's Phase 2 clinical study of otelixizumab

Oct 22 2009

Tolerx, Inc., a biopharmaceutical company developing novel therapies intended to treat diabetes, other autoimmune diseases and cancer by specifically modulating T-cell activity, today presented dose optimization data from its Phase 2 clinical study of otelixizumab in subjects with type 1 diabetes. Otelixizumab is a targeted T-cell immunomodulator currently being evaluated in DEFEND, a Phase 3 clinical study in subjects with new-onset autoimmune type 1 diabetes. Data from the Phase 2 dose optimization study, which were used to determine the dose in the DEFEND trial, were presented at the International Diabetes Federation's 20th World Diabetes Congress currently taking place in Montreal, Canada.

In an oral presentation entitled "Otelixizumab - Dose regimen optimization of a humanized aglycosylated anti-CD3 monoclonal antibody in adult subjects with type 1 diabetes mellitus," Dr. Louis Vaickus, Chief Medical Officer at Tolerx, presented preliminary data from the Phase 2 otelixizumab dose optimization clinical study, referred to as TTEDD.

In a previous investigator-sponsored Phase 2 study, a high dose (48-64 mg) of otelixizumab was shown to preserve natural insulin production for up to 48 months after a single course of treatment. Subsequently, Tolerx initiated TTEDD to investigate alternative dosing regimens that would minimize adverse events, while maintaining durable clinical activity. A cumulative dose of 3.1 mg of otelixizumab administered over 8 days was identified as the optimized dose suitable for further evaluation. In TTEDD, this dosing regimen resulted in preservation of beta cell function (as measured by C-peptide, a common marker for endogenous insulin production) for up to 12 months in patients with autoimmune new-onset type 1 diabetes with no observation of significant safety issues.