Greenwich LifeSciences (GLSI) said Thursday the European Medicines Agency has approved the enrollment of both HLA-A*02 and non-HLA-A*02 patients in a phase 3 trial evaluating GLSI-100 in preventing breast cancer recurrences.
The company said all 170 to 180 clinical trial sites in the US and Europe are now operating under the same protocol and are enrolling both HLA populations.
Greenwich said it was still awaiting feedback from UK and Canadian regulators and that it now has a pathway to pursue approval of its investigational immunotherapy for both HLA populations.
Shares of the company were up more than 5% in premarket activity Thursday.