Bio-Path stated that the Phase I clinical trial is a dose-escalating study to determine the safety and tolerance of escalating doses of L-Grb-2. The pharmacokinetics of L-Grb-2 in patients will be studied, making it possible to investigate whether the delivery technology performs as expected based on pre-clinical studies in animals. The trial is expected to evaluate five doses of L-Grb-2.
Peter Nielsen, president and CEO of Bio-Path, said: “Liposomal Grb-2 is the first cancer drug candidate in Bio-Path’s lipid vehicle delivery platform to begin clinical trials.
“A second important outcome for the Phase I clinical trial is the ability to assess the performance of the company’s delivery technology platform in human patients.
“Being platform technology, a successful demonstration of the delivery technology in this study will allow the company to immediately begin expanding Bio-Path’s drug candidates by simply applying the delivery technology template to multiple new drug product targets.”