FDA grants orphan drug designation to LP-184 for pancreatic cancer
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The FDA granted orphan drug designation to LP-184 for the treatment of pancreatic cancer.
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.
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.
Discussions are underway on the design of first-in-human studies of LP-184.
“Receipt of orphan drug designation is an important accomplishment for the LP-184 program and for our company,” Panna Sharma, president and CEO of Lantern Pharma, said in the release. “We are excited to advance this groundbreaking research to help patients suffering from this devastating disease where the benefits of current treatment options are very limited.”
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.
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