The data from the BrachySil trial was presented at the ESTRO conference in Budapest on 3 May. Here is the abstract for the presentation:
Proof of concept of novel 32P Brachytherapy device in hepatocellular carcinoma (HCC) in man
A.Goh1, R. Lo(1), T.N. Lau(1), A.Y. Chung(1), D. Ng(1), W.K. Yu(1), S. Loong(2), M. Chng(1), S. Somanesan(1), B.C. Lim(3), S. Connor(4), P.K.Chow(1)
1 Singapore General Hospital
2 National Cancer Center Singapore
3 pSiOncology Pte Singapore
4 pSiMedica Ltd, Malvern UK
Hepatocellular carcinoma (HCC) is the 4th most important malignancy worldwide. The vast majority of HCC are however unresectable and therapy in this group remains poorly efficacious and the prognosis dismal. Interstitial brachytherapy of solid hepatic tumours such as HCC is potentially advantageous but the requisite for widespread clinical application is a delivery vehicle with properties that can reliably confine the radiation source to the implantation site. A novel implantable medical device comprising 32P and proprietary porous silicon, BioSilicon(™) (BrachySil(™)) was investigated in eight patients with non-resectable HCC in an open label single dose trial. Patients received single intratumoural implantations introduced percutaneously under sonographic / imaging guidance into a maximum of three tumours (4 MBq/ml tumour). The procedure was very well tolerated by all patients. Follow-up assessment at close intervals up to 12 weeks demonstrated no significant product-related adverse clinical or haematological effects. Examination of blood parameters suggested no extrahepatic leakage of radioactivity from the device implanted. Although the primary objective of the study was to determine safety and tolerability, the anti-cancer activity of BrachySil™ was confirmed with CT evaluations showing significant tumour regression at all implantation sites. The study establishes proof of principle for BrachySil(™) in the treatment HCC as a tolerable and effective brachytherapy agent.
Pess
PSD
psivida limited
