Starlight Therapeutics, a wholly owned subsidiary of Lantern Pharma (NASDAQ: LTRN), has achieved a significant milestone with the FDA's clearance of its Investigational New Drug (IND) application. This approval paves the way for a Phase Ib/2a clinical trial evaluating STAR-001 (LP-184) in combination with spironolactone for patients suffering from glioblastoma multiforme (GBM) at first progression. GBM is a highly aggressive form of brain cancer with currently limited treatment options, making this development a potential game-changer in oncology.
The trial will focus on assessing the safety, tolerability, and preliminary efficacy of the combination therapy in recurrent GBM. STAR-001 is a brain-penetrant DNA-damaging agent designed to target DNA repair deficiencies through synthetic lethality, with its effectiveness enhanced by spironolactone, which induces NER deficiency in tumor cells. This innovative approach has already garnered Orphan Drug and Fast Track designations from the FDA, underscoring its potential to address unmet medical needs in GBM treatment.
Leveraging Lantern Pharma's AI-driven RADR(R) platform, the program aims to identify optimal patient populations and accelerate development timelines. This trial builds on promising data from an ongoing Phase 1a trial, highlighting the synergy between advanced AI technology and drug development to bring forth novel therapies more efficiently.
For more details on the press release, visit https://ibn.fm/8ndAq. This development not only represents a significant step forward in the fight against GBM but also showcases the transformative potential of AI in oncology drug discovery and development.
