OSLO, Norway--(BUSINESS WIRE)--Targovax has today presented safety data and immunological results from the ongoing phase I/II clinical study CT-TG01-01, testing the therapeutic cancer vaccine TG01 in combination with gemcitabine in patients with resected pancreatic cancer at the 2015 ASCO Annual Meeting in Chicago. The preliminary results from the study indicate that about 80% or more of the patients mount an immune response to TG01.
Totally 19 patients had received TG01 treatment and 18 had received both TG01 and gemcitabine treatment. The regimen was generally well tolerated with related events to TG01/molgramostim being those expected (local reactions and flu-like symptoms) for a peptide vaccine. Grade 3/4 reactions were primarily related to gemcitabine. There were 4 related allergic reactions to vaccination, three of which occurred only after gemcitabine treatment; two of which were severe. Of the totally 17 patients eligible for immune response assessment at the date of analysis, 14 (82%) had established a detectable immune response to TG01. In the main group of patients starting TG01 treatment 3 weeks prior to initiating gemcitabine treatment, 13 of 14 (93%) patients had an immune response and 1 of 3 (33%) in the concomitant group starting TG01 and gemcitabine treatment at the same time. 12 months survival results are expected in Q1 2016.
Professor Daniel H. Palmer, University of Liverpool Cancer Research UK Centre, Liverpool, United Kingdom, says:” I am excited to lead Targovax’s phase I/II clinical trial in resected pancreatic cancer. The results we present at ASCO today show that Targovax’s TG01 cancer vaccine is generally well tolerated and does provoke prevailing RAS mutation specific immune responses detectable in nearly all patients when used in combination with gemcitabine. The successful combination of this active immunotherapy with chemotherapy is very encouraging and it will be very interesting and exciting to follow up the patients as the clinical trial progresses.”
“We are very encouraged by the data produced thus far in the Phase I/II study," said Gunnar Gårdemyr, Chief Executive Officer of Targovax As. "The data confirms the strong result we saw in the earlier Phase I study when it comes to tolerability and immune response. This supports the continued development of TG01 and we are excited to take TG01 into the next development phase"