Another site has enrolled its first patient in RenovoRx’s Phase III trial evaluating a drug-device combination therapy to treat locally advanced pancreatic cancer.
The latest enrolment – at the University of Nebraska Medical Center (UNMC) – joins other clinical sites across the US and Belgium.
RenovoRx’s chief clinical officer Leesa Gentry said in a 14 August statement: “We believe UNMC will help drive enrollment of the TIGeR-PaC trial to completion next year because they treat a larger number of patients diagnosed with pancreatic cancer.”
The TIGeR-PaC study (NCT03257033), which has an enrolment target of 190 patients, is trialling RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) therapy platform, which aims to facilitate the penetration of chemotherapy drugs into the tumour.
UNMC associate professor Kelsey Klute said: “One of the biggest challenges in treating pancreatic cancer is that the tumour cells build a thick layer of scar tissue around the tumour, and this scar tissue makes it difficult for drugs to penetrate the tumour itself.”
Kelsey says this is one of the reasons that many investigational drugs in pancreatic cancer trials fail as they simply aren’t reaching the tumour at a high enough concentration to have an effect.
RenovoRx’s TAMP is designed to administer chemotherapy through the layer of scar tissue via pressure-mediated delivery. The therapy consists of the drug and an FDA-cleared dual-balloon infusion delivery system. The therapy is delivered into an artery next to the pancreatic tumour, which then perfuses across the vessel wall.
After an induction period, pancreatic adenocarcinoma patients in the randomised trial will either receive Eli Lilly’s chemotherapy drug Gemzar (gemcitabine) intra-arterially alone or Gemzar with another chemotherapy drug Abraxane (nab paclitaxel). The treatment regimen will last for 16 weeks or until progression.
Both groups will then receive either IV Gemzar and nab-paclitaxel or oral capecitabine following the four-month course and be assessed for survival for five years. The trial’s primary endpoint is overall survival within this period while secondary endpoints include reduced side effects compared to standard-of-care.
There are a host of pancreatic cancer candidates in clinical trials as companies aim to go beyond the efficacy of current chemotherapies. Alligator Bioscience and Verastem Oncology reported data for their respective candidates at this year’s American Society of Clinical Oncology (ASCO) annual meeting, with improved objective response rate and overall survival compared to chemotherapy. BioNTech, meanwhile, has made waves with its mRNA vaccine for the cancer – the asset is currently in a Phase II trial.
