Targovax To Expand On-Going Phase I/II CT-TG01-01 Pancreatic Cancer Study With A New Group Of Up To 13 Patients

OSLO--(BUSINESS WIRE)--Immunotherapy specialist Targovax’s lead compound TG01, a novel peptide vaccine against cancer specific RAS mutations, is currently being tested in a Phase I/II study in combination with gemcitabine as an adjuvant treatment in resected pancreatic cancer. The purpose of the trial expansion announced today is to build on the positive findings of immune responses to further optimise the TG01 treatment regimen and safety profile of the combination therapy. The submission for regulatory approvals is planned for the end of March.

“Although we have already achieved the primary endpoints of the study we believe that there is a potential for further optimisation of the combination treatment regimen. Potentially this might further improve the immunological effect of TG01 when combined with gemcitabine as well as reducing the overall number of vaccinations which will enhance the safety profile. Results from the new group of patients will be of great value for us when it later comes to designing our upcoming randomised proof of concept study. Adding a new group of patients in an already on-going study will save us time and money. We aim to start enrolment of patients in May 2015” says Gunnar Gårdemyr, CEO of Targovax.

Background:

CT TG01-01 is a single arm study testing the peptide based cancer vaccine TG01 in combination with gemcitabine for adjuvant treatment of resected/operated pancreatic cancer. TG01 targets cancer specific RAS mutations in pancreatic cancer. Today gemcitabine is the most frequently used standard of care chemotherapy for pancreatic cancer. The primary objectives of the study are safety and induction of TG01 immune response. Secondary objectives are safety, immune response and observation of survival up to two years. The study is being conducted in the UK and Norway. RAS mutations occur in approx. 20% of all cancer cases, and are also frequent in colorectal cancer, non-small cell lung cancer and other cancers. Patients with RAS mutations within these indications have proved to be difficult to treat with current treatments, and there is a significant unmet medical need.