pSivida公司用于胰腺癌短距离放射治疗的新产品

一项评估新型胰腺癌非粒子短距离放射治疗临床试验，计划在2005年末之前开始。

BrachySil是由pSivida公司研制开发的，是一种微米大小的颗粒，其中包含磷32同位素。这种颗粒独特之处是其高效同位素保持能力，从而减少了对正常肝脏组织的放射损伤，或者减少进入循环导致全身毒性的可能。

最近进行的临床试验在原发性肝癌中完成，提供的大量资料显示：这种非粒子的安全性、有效性（在某些病例较小肿瘤出现了100％的肿瘤抑制），能够通过细针注射给药。BrachySil在注射部位的保持能力是这些临床试验获得了又一个显著结果。多中心关键注册临床试验计划在2005年之前开始，目的是获得结果，以支持这种非粒子被批准用于治疗原发性肝癌。

pSivida公司执行主任Gavin Rezos说：“第二项开发方案将为BrachySil已有的药理学、制造工艺以及临床经验提供强有力的基础，从而建超常规审批程序以及商业化操作的风险。”
 
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.