FDA grants orphan drug designation to LP-184 for glioblastoma multiforme
Click Here to Manage Email Alerts
The FDA granted orphan drug designation to LP-184 for the treatment of glioblastoma multiforme and other malignant gliomas.
LP-184 (Lantern Pharma) is a next-generation alkylating agent designed to preferentially damage DNA in cancer cells that overexpress certain biomarkers or harbor mutations in DNA repair pathways, according to a Lantern Pharma-issued press release.
The agent is in development for several targeted indications in oncology.
LP-184 acts by damaging DNA selectively in tumors that express high levels of the enzyme PTGR1. Analyses conducted with RADR — Lantern Pharma’s proprietary machine learning-based artificial intelligence platform — identified glioblastoma multiforme that has elevated PTGR1 expression and harbors defects in DNA damage repair components as a targeted group of genetically defined patients who may benefit from therapy that includes LP-184.
Preclinical data showed LP-184 inhibited tumor growth and improved survival in animal models of glioblastoma multiforme, according to Panna Sharma, president and CEO of Lantern Pharma.
“We believe LP-184's ability to cross the blood-brain barrier, together with its antitumor efficacy and sensitivity correlations with relevant biomarkers, highlight LP-184's potential to be used as both monotherapy as well as a synergistic agent in combination with other drugs to address the unmet needs in glioblastoma multiforme and other aggressive central nervous system tumors,” Sharma said in a company-issued press release.
The FDA previously granted orphan drug designation to LP-184 for treatment of pancreatic cancer.
Results of research conducted in in-vivo mouse models showed LP-184 shrunk pancreatic tumors by more than 90% over 8 weeks. Tumors in untreated mice grew by 11-fold during the same period.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
Read more about
Click Here to Manage Email Alerts