一項評估新型胰腺癌非粒子短距離放射治療臨床試驗，計劃在2005年末之前開始。

BrachySil是由pSivida公司研制開發的，是一種微米大小的顆粒，其中包含磷32同位素。這種顆粒獨特之處是其高效同位素保持能力，從而減少了對正常肝臟組織的放射損傷，或者減少進入循環導致全身毒性的可能。

最近進行的臨床試驗在原發性肝癌中完成，提供的大量資料顯示：這種非粒子的安全性、有效性（在某些病例較小腫瘤出現了100％的腫瘤抑制），能夠通過細針注射給藥。BrachySil在注射部位的保持能力是這些臨床試驗獲得了又一個顯著結果。多中心關鍵注冊臨床試驗計劃在2005年之前開始，目的是獲得結果，以支持這種非粒子被批準用于治療原發性肝癌。

pSivida公司執行主任Gavin Rezos說：“第二項開發方案將為BrachySil已有的藥理學、制造工藝以及臨床經驗提供強有力的基礎，從而建超常規審批程序以及商業化操作的風險?！?
 
Pancreatic Cancer Brachytherapy
 
A study evaluating the efficacy and safety of a novel brachytherapy nanoparticle for pancreatic cancer is planned to start before the end of 2005.

BrachySil, developed by pSivida (Perth, Australia), is a micron-sized particle in which the isotope 32-phosphorus is immobilized. This particle is unique in that it demonstrates a very high degree of isotope retention, thereby reducing the risk of radioactivity effecting normal hepatic tissue or entering the circulation and causing systemic toxicity.

The clinical study currently being done is for primary liver cancer and has provided considerable data showing the nanoparticle’s safety, efficacy (up to 100% tumor regression in some instances for smaller tumors), and ease of administration by way of a fine-gauge needle injection procedure. The ability of BrachySil to remain at the injection site has been another significant outcome of the trials. Multicenter pivotal registration trials are planned to start during 2005 to provide results to support registration of the nanoparticle as an approved treatment for primary liver cancer.

“This second significant development program will benefit enormously from the strong foundation of pharmaceutical, manufacturing, and clinical experience already available for BrachySil, and therefore reduces risk in the pathway to regulatory approval and commercialization,” stated Gavin Rezos, managing director of pSivida.