The single-dose, dose-escalating phase I study examined the safety and tolerability of a single injection of the drug in 24 healthy volunteers.
Biothera plans to initiate a multiple-dose, dose-escalation phase I clinical study in June. The study is designed to generate additional safety data, including pharmacokinetic and pharmacodynamic data.
Biothera is also preparing to launch a phase II clinical program that will include a series of trials featuring a combination of Imprime PGG and various monoclonal antibodies and growth factors to treat a number of indications.
“We are very pleased to have successfully completed our first trial in humans,” said Dr Myra Patchen, executive vice president of pharmaceutical development for Biothera. “We are on track for moving quickly to proof of concept phase II trials.”