Targovax announces that the open label Phase I/ II clinical trial of TG01 in combination with gemcitabine of patients with resected pancreatic cancer is fully recruited.
A total of 32 patients have been included in the trial, with 13 patients in the modified cohort.
“We are happy to announce that we have completed the recruitment of our study. The patients will be monitored for the next 24 months” says Anne-Kirsti Aksnes, VP Clinical Development in Targovax. “We are on track for final results, including two-year survival data in both cohorts, in 1H 2017 and 1H 2018 respectively.”
The trial is an open label, phase I/II study of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. In the second cohort, the patients have received a modified vaccination regiment.
In April 2016, Targovax announced preliminary immune activation data from this second cohort, which showed that a modified vaccination schedule also induced an immune response at week 8, after the induction phase.
In March 2015, Targovax announced the immune results from the first cohort of the trial, indicating that 18 out of 19 patients were eligible for immune response assessment and 15 patients had established a detectable immune response.