SAN DIEGO (AP) – Ligand Pharmaceuticals Inc. said it will start a new trial of a potential cancer drug, and if studies are successful, it will seek marketing approval in mid-2013.
Ligand said it plans to start a pivotal trial in early 2012, enrolling about 60 patients with multiple myeloma, a cancer that affects plasma cells in bone marrow. It plans to file with the Food and Drug Administration by mid-2013 if the study is successful. The company is planning to report full results from a mid-stage study during the fourth quarter.
The company is studying a version of the drug melphalan, which is already used to treat multiple myeloma. Ligand said its version of the drug excludes an ingredient that is reported to cause kidney and heart side effects. Those side effects force physicians to use smaller doses of the drug, and Ligand said its version would make it possible to treat patients longer, use slower infusions, and possibly use higher doses safely.
Ligand’s drug candidate has received orphan drug status from the FDA, meaning the company will have up to seven years of marketing exclusivity if it is approved. Orphan drug status is given to treatments for rare diseases and to diseases that have few available treatments.
Date: June 22, 2011
Source: Associated Press
Filed Under: Drug Discovery