Recruitment completed for phase I/II study with LTX-315
Lytix Biopharma announces today that recruitment has been completed for the open label Phase I/ II study with LTX-315 in end-stage patients with advanced solid tumors. Thirteen clinical sites in five European countries have participated in this study. A total of 64 patients have been included in three arms receiving treatment with either intratumoral LTX-315 as monotherapy (multiple tumor types) or in combination with ipilimumab (malignant melanoma) or in combination with pembrolizumab (triple negative breast cancer). The main clinical results will be presented at American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago, 1st – 5th June, 2018.
"Completing the recruitment of this clinical study with LTX-315 marks an important milestone that will propel forward its clinical development. We thank the patients and health professionals who participated in this study and we look forward to present the data at the upcoming ASCO" says Edwin Klumper, CEO of Lytix Biopharma ASA.
At ASCO, data on safety (primary endpoint) and on clinical efficacy and immune responses (secondary endpoints) will be presented for LTX-315 monotherapy and for LTX-315 in combination with either ipilimumab or pembrolizumab. Preliminary results of LTX-315 monotherapy, presented previously at the European cancer congress 2015 and at ASCO 2017, demonstrated that intratumoural LTX-315 has a manageable safety profile, induces increased Tumor Infiltrating Lymphocytes (TILs) and partial and complete regression in injected tumor lesions.