-- Delta-Fly Pharma (TYO:4598) is preparing to begin discussions with the U.S. FDA on its AML drug DFP-10917 following clinical trial results, according to a Thursday filing on the Tokyo Stock Exchange.
An interim Phase 3 study of monotherapy did not meet its primary endpoint but showed higher response rates and signs of survival benefit in certain subgroups.
Combination therapy with venetoclax demonstrated response rates above 50% in early-stage trials, with some patients moving to stem cell transplants.
The company is also in talks with overseas pharmaceutical firms for potential co-development and global trials.