12-16 weeks for CE mark approval, page-39

Here is the abstract for those who would like to see it.

EP-0692 Practical and Technical Experience of using 32P-OncoSilTM in treating patients with unresectable locally advanced pancreatic adenocarcinoma, in combination with FOLFIRINOX or gemcitabine +nab-paclitaxel chemotherapies. N. H. Patel1, K. S. Nijran1, N. Phillips1, C. Bowen1, J. J. Phillips1, H. Wasan1, C. Wadsworth1, T. Maher2, H. A. Peck1, K. Pudge1, E. Pickford1, K. Desai1, Z. Win1; 1Imperial College Healthcare NHS Trust, London, UNITED KINGDOM, 2OncoSil Medical Ltd, Sydney, AUSTRALIA.

Purpose: To share our experience of treating patients with unresectable locally advanced pancreatic adenocarcinoma using 32P-OncoSilTM, an open-label, single arm pilot study, performed by OncoSil Medical Ltd. Imperial College Healthcare NHS Trust is the highest recruiter in the UK/Europe. 26 patients have been treated in Australia, 5 in the UK and 2 in Belgium, a total of 33 participants worldwide. Method: The study evaluates the safety and efficacy of 32P-OncoSilTM given in combination with systemic chemotherapy, when implanted directly into pancreatic tumours under endoscopic ultrasound guidance (EUS-FNA) using a 22G needle. The activity of 32P-OncoSilTM was calculated by taking 8% of the CT tumour volume and multiplying by the specific activity concentration of 32P OncoSil TM (6.6MBq/ml); giving an intended average tumour dose of 100Gy (+20%). Blood and urine sampling for radioactivity concentration and safety was conducted. Bremsstrahlung imaging was performed within 4 hours of implantation and on day 7 post implantation. 18F-FDG PET/ CT imaging was performed at screening and week 12 to assess metabolic tumour response according to PERCIST criteria. Results and Discussion: Four patients have been treated to date (62-84 years, 2 male, 2 female). Tumour access was easy and the intended activity for implantation (4.8-16.4MBq) was successfully delivered for all patients. Two patients had 32P-OncoSilTM implanted into the pancreas head, one in the uncinate, and one in pancreas head/uncinate. The single deposit method was used for central tumour delivery in two patients with SEMS in situ. In one patient, the tracking deposit method was used because of a cyst in the line of implantation site which was aspirated in single pass prior to implantation. 32P-OncoSilTM distribution in the tumour was estimated to be 26-50% in all patients. In most cases the shielded syringe was easy to attach to the endoscope; there was variable resistance to syringe plunger force during implantation. In one case, resistance encountered required higher plunger pressure and repositioning of the needle. It was easy to dissemble the implantation device and decontaminate the endoscope in all cases. Conclusion: 32P-OncoSilTM was successfully delivered for four patients at our centre. Bremsstrahlung imaging confirmed successful delivery of 32P-OncoSilTM in all cases. In two cases where follow-up 18F-FDG PET/CT imaging has been completed; both demonstrated focal photopenia at the site of 32P-OncoSilTM delivery, with one showing reduction in bulk of the pancreatic mass.