ARTICLE | Top Story
Matrix to submit NDA by year end
May 22, 2000 7:00 AM UTC
MATX released data from two Phase III trials of its IntraDose cisplatin/epiniphrine injectable gel to treat head and neck cancer, which the company said will allow it to submit an NDA with the FDA before the end of the year. An 86-patient North American trial showed a 34 percent response rate versus 0 percent for placebo (p=0.001). The second trial, a 92-patient study conducted outside North America, showed a 25 percent response rate compared to 3 percent for placebo (p=0.007). ...