Otelixizumab
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Formula | C6448H9954N1718O2016S42 |
Molar mass | 145145.09 g·mol−1 |
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Otelixizumab, also known as TRX4, is a
Mechanism of action
Otelixizumab is one of several
Proof of concept was established in a randomized, placebo-controlled Phase 2 study. These data demonstrated otelixizumab's ability to preserve beta cell function, as measured by C-peptide, in patients up to 18 months after dosing, as well as reduce the need for delivered insulin to maintain glucose control.[5][6]
Clinical progress
The efficacy and safety of otelixizumab for the treatment of autoimmune type 1 diabetes was studied in a pivotal Phase 3 study called DEFEND (Durable-response therapy Evaluation For Early or New-onset type 1 Diabetes).[7] DEFEND was a randomized, placebo-controlled Phase 3 trial designed to enroll approximately 240 adult patients, age 18 to 45, with newly diagnosed autoimmune type 1 diabetes. DEFEND was conducted at multiple centers in North America and Europe. The trial was designed to evaluate whether a single course of otelixizumab, administered not more than 90 days after the initial diagnosis, would reduce the amount of administered insulin required to control blood glucose levels by inhibiting the destruction of beta cells.[8] The trial failed to show efficacy of the treatment.[9]
Orphan drug status
Otelixizumab has been granted "
Chemistry
As a monoclonal antibody, otelixizumab consists of two
References
- S2CID 25876507.
- ^ "Windhover Information "GSK buys rights to Tolerx's diabetes antibody otelixizumab"". Archived from the original on 2011-07-18. Retrieved 2009-04-13.
- ^ "TolerRx Inc., of Cambridge, Mass., entered an agree- ment with Abbott Park, Ill.-based Abbott Laboratories for the manufacturing of TolerRx's TRX4 monoclonal antibody" (PDF). Bioworld Today. Vol. 16, no. 228. Thomson Bioworld. 20 November 2005. p. 6. Retrieved 2 December 2009.
- S2CID 11868182.
- PMID 15972866.
- S2CID 36595661.
- ^ Clinical trial number NCT00678886 for "Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1 (DEFEND-1)" at ClinicalTrials.gov
- ^ "DEFEND is a Phase 3 clinical study". Archived from the original on 20 February 2009.
- ^ "Tolerx, Inc. and GlaxoSmithKline (GSK) Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint". Biospace. Archived from the original on 2011-09-29.
- ^ "N.E. drug makers find individual paths into growing diabetes arena". Mass High Tech. May 16, 2008. Archived from the original on February 15, 2009. Retrieved April 13, 2009.
- ^ "Recommended INN List 60" (PDF). WHO Drug Information. 22 (3). 2008. Archived from the original (PDF) on March 7, 2012.