胃泌激素17疫苗——Aphton: Anti-gastrin 17免疫原,G17DT。

文章的细节

引用

复制到剪贴板

作者不明

胃泌激素17疫苗——Aphton: Anti-gastrin 17免疫原,G17DT。

BioDrugs。2003;17 (3):223 - 5。

PubMed ID

12749761 (在PubMed

]

文摘

Aphton发展anti-gastrin疫苗(anti-gastrin 17免疫原,G17DT Gastrimmune],以助中和胃泌激素17激素和Gly-G17激素。胃泌激素17是胰腺癌的生长因子,胃和结肠直肠癌的有力刺激胃酸分泌。G17DT anti-gastrin的免疫原,由一个大的载体蛋白,称为白喉类毒素(DT)。合成肽,它类似于17部分胃泌激素激素(GT),是连接到载体蛋白。这些都是包含在液体悬浮车。当管理病人,G17DT诱发免疫反应产生的抗体,并抵消目标激素从而防止交叉反应与致病或参与细胞的相互作用。Aphton已经进入一个协议与安万特巴斯德的营销G17DT在所有人类癌症迹象在北美和欧洲。根据协议条款,Aphton负责产品开发、临床试验和监管机构的批准。该协议最初是与巴斯德Merieux守诺,Rhone-Poulenc的子公司。然而,1999年12月,Rhone-Poulenc与赫斯特合并形成安内特。由于合并,巴斯德Merieux安万特巴斯德诺接受了名称的改变。 In July 2002, Aphton announced that it would negotiate with companies wanting to licence the vaccine in territories other than North America and Europe. In February 2003, Aphton announced it had received fast track designation for G17DT in combination with cisplatin and fluorouracil for use in stage IV gastric cancer to improve overall survival. In July 2002, the US FDA granted G17DT orphan drug status for the treatment of gastric cancer, an indication that was broader than the indication Aphton originally sought. The vaccine was also granted orphan drug status in Australia for gastric cancer in December 2002. In July 2002, Aphton announced that the US FDA had granted G17DT orphan drug status for the treatment of adenocarcinoma of the pancreas. In September 2002, the US FDA also granted G17DT, used in combination with gemcitabine, fast track status for the treatment of pancreatic cancer patients. In addition, the vaccine was also granted orphan drug status in Australia for pancreatic cancer in December 2002. In March 2003, Aphton announced that the Committee for Orphan Medicinal Products had recommended to the European Commission that G17DT be granted orphan drug status for both pancreatic and gastric cancer in the EU. Aphton expects this will be approved and ratified within a few weeks. In August 2002, Aphton filed an IND with the US FDA, as well as the European equivalent, to conduct clinical trials for patients suffering from gastro-esophophageal reflux disease (GERD). The trials will assess, among other endpoints, the efficacy of G17DT in providing symptomatic relief to patients with GERD. In November 2002, Aphton announced that it had received approval to initiate a clinical trial in Europe. Additionally, Aphton has agreed with the FDA to conduct toxicology and other preclinical studies prior to initiation of a trial in the US. Patient recruitment for the European study was scheduled to begin in January 2003.

DrugBank数据引用了这篇文章

药物

G17DT