HUMAN GENOME SCIENCES REPORTS RESULTS OF HGS-ETR2 STUDY
Human Genome Sciences has announced that the results of two Phase I clinical
trials demonstrate that HGS-ETR2 is well-tolerated and can be administered safely
and repetitively in patients with advanced solid tumors, and support further
evaluation in Phase II trials. Stable disease was observed in a number of patients
in each of the studies.
The trials were open-label, dose-escalation, two-center studies. Patients participating
in the studies previously received multiple cancer treatment regimens, including
chemotherapy, immunotherapy, radiotherapy, hormone therapy and/or surgery. The
patients were enrolled into six cohorts and received HGS-ETR2 administered intravenously
on a 21-day schedule, with dosing to disease progression in the absence of dose-limiting
toxicities.
Results demonstrated that HGS-ETR2 was well-tolerated, with minimal toxicity
at doses up to 10 mg/kg, and could safely be administered intravenously every
21 days. Dose-limiting toxicity (DLT) was defined at a dose of 20 mg/kg. No
DLTs occurred at the 10-mg/kg dose level. The pharmacokinetics of HGS-ETR2 were
found to be linear across a 200-fold dose range. Stable disease was observed
in 11 of these heavily pre-treated patients, including patients with refractory
sarcoma.