FDA Clears Lantern Pharma, Starlight Therapeutics to Begin Phase 1 Trial for Pediatric CNS Cancers

Lantern Pharma and Starlight Therapeutics have received clearance from the U.S. Food and Drug Administration (FDA) for their Investigational New Drug (IND) application for STAR-001. The approval allows the companies to proceed with a planned Phase 1 clinical trial targeting pediatric central nervous system (CNS) cancers. This trial will focus on evaluating the safety, tolerability, and initial efficacy of STAR-001 in children diagnosed with these aggressive forms of cancer.

The upcoming Phase 1 trial marks a significant step in advancing research into treatments for pediatric CNS cancers, which remain among the most challenging to treat. Lantern Pharma and Starlight Therapeutics aim to assess STAR-001’s potential therapeutic benefits through this study. The FDA’s clearance follows a review of preclinical data submitted by the companies, which included information on STAR-001’s mechanism of action and its potential impact on tumor cells in laboratory settings. Further details regarding the timeline or specific locations for the trial were not disclosed at this time.

https://www.geneonline.com/fda-clears-lantern-pharma-and-starlight-therapeutics-to-begin-phase-1-trial-of-star-001-for-pediatric-cns-cancers/