The FDA has also granted orphan drug designation to SGN-40 for chronic lymphocytic leukemia (CLL) providing Seattle Genetics with seven years of marketing exclusivity in the event of market approval, as well as the opportunity to obtain grant funding from the US government. The drug has also been granted orphan drug designation in its multiple myeloma indication.
“We believe that SGN-40 may be an important therapeutic in the treatment of many types of B-cell malignancies,” stated Dr Clay Siegall, president and CEO of Seattle Genetics. “Initiating this clinical trial in CLL and receiving orphan drug designation are important accomplishments toward further expanding our opportunities for this program.”
The single-agent phase I/II study will evaluate the tolerability, pharmacokinetic profile and antitumor activity of a multi-dose regimen of SGN-40 in relapsed or refractory CLL patients. The study design allows rapid transition from the phase I dose-escalation portion into a phase II trial.
Seattle Genetics plans to enroll approximately sixty patients in the phase I/II study at multiple cancer centers in the US.