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# FDA Gives Gibson a Rare Pediatric Disease Designation
- URL: https://www.fdaweb.com/fda-gives-gibson-a-rare-pediatric-disease-designation/
- Published: 2018-12-13T12:00:00.000Z
- Updated: 2026-09-15T00:50:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143039

FDA has granted Gibson Oncology a Rare Pediatric Disease Designation for LMP-400, the company’s novel small molecule topoisomerase 1inhibitor for treating Ewing sarcoma, a rare pediatric cancer. LMP-400 has completed multiple Phase 1 human clinical trials as a single agent in advanced stage cancer patients, with the therapy demonstrating anti-cancer activity and improved safety attributes over first generation topoisomerase inhibitors, the company says. Ewing sarcoma is the second most common bone malignancy among children and adolescents.

Gibson says it is planning to conduct Phase 2 trials with LMP-400 that will employ a recently discovered biomarker called Schlafen11 to select pediatric patients most likely to respond. In a previous study at the National Cancer Institute, cancer cells expressing high levels of Schlafen11 were hypersensitive to LMP-400, it says, adding that Ewing Sarcoma patients commonly have very high expression levels of Schlafen11.