| | 胰腺癌专题 >> VIRULIZIN 胰腺癌治疗药物 |
|
|
| VIRULIZIN 胰腺癌治疗药物 | |
| VIRULIZIN 胰腺癌治疗药物 Lorus Therapeutics公司Virulizin是一种新型免疫治疗药物，能刺激患者的天然免疫系统，激活巨嗜细胞和NK细胞浸润到肿瘤中。该药已经获得美国FDA的罕见药资格、快速审批药物资格以及特殊协议评价（SPA）的授权。 Virulizin® Immunotherapy is a promising therapeutic method that harnesses the power of the immune system to fight cancer. Virulizin® is a novel immunotherapy agent that stimulates the body’s immune system through several mechanisms, including the activation of macrophages and the infiltration of natural killer cells into tumors. Virulizin® also induces the expression of several cytokine proteins such as IL-12 and IL-17E, which act as chemical messengers to boost the cellular immune response against cancer. These combined activities have significant antitumor effects, while showing a high margin of safety. In preclinical studies, Virulizin® has demonstrated antitumor activity against a wide range of cancer indications, including breast, ovarian, and pancreatic cancers. Virulizin® has been evaluated in hundreds of cancer patients and has demonstrated an excellent safety profile with only a small number of mild adverse events. Virulizin® has completed three Phase I/II clinical studies in solid tumors and pancreatic cancers. Virulizin® has also completed a randomized placebo-controlled Phase III trial for the first line treatment of pancreatic cancer in combination with gemcitabine. Top-line results from the trial did not demonstrate statistical significance in median overall survival but exploratory analysis showed promising trends in specific patient populations and, in line with Lorus’ corporate mission, Virulizin® treatment was well tolerated with no major side effects. Lorus is involved in providing technical assistance and know-hows to its partner Zor Pharmaceuticals who is currently planning for additional clinical studies to confirm the survival benefit associated with Virulizin® in a predefined patient subpopulation. These clinical trials will be designed to support approval of Virulizin® in jurisdictions covered under our license agreement with Zor (North and South America, Europe, and Israel). We also believe that Virulizin® has strong partnership potential for other countries throughout the world. Virulizin® has been granted orphan drug status and fast track status from the United States FDA and orphan designation from the Marketing Authorization Application with the European Medical Evaluation Agency (EMEA) for treatment of pancreatic cancer. Virulizin® is protected by multiple patents worldwide, as part of Lorus’ extensive intellectual property estate. Virulizin ® 免疫治疗是一种很有前途的治疗方法，运用免疫系统的力量，以对抗癌症。 Virulizin ®是一种新型的免疫刺激剂，通过各种机制人体的免疫系统，包括巨噬细胞活化并肿瘤自然杀伤细胞的浸润。 Virulizin ®也诱导，如白细胞介素数因子的蛋白表达- 12和IL - 17E条，其中作为化学信使，以刺激细胞对癌症的免疫反应。这些联合活动有重要的抗肿瘤作用，同时也显示出安全的高利润。 在临床前研究，Virulizin ®表现出对癌症的迹象，其中包括乳腺癌，卵巢癌广泛的抗肿瘤活性，和胰腺癌。 Virulizin ®已被评价的癌症患者数百名，并显示了只有轻微的不良反应事件的少数良好的安全性。 Virulizin ®已完成三个阶段I /在实体肿瘤和胰腺癌Ⅱ期临床研究。 Virulizin ®还完成了一项随机安慰剂对照为胰腺癌的第一线，与吉西他滨联合治疗III期临床试验。从试验前行的结果并没有表现出在中位总生存的统计意义，而且探索性分析表明，在特定的患者群的可喜趋势，并与省Lorus\'的企业使命，Virulizin ®热处理生产线是与没有大的副作用不能容忍的。 参与省Lorus是在提供技术援助和知识hows给其合作伙伴佐尔制药谁是目前更多的临床研究规划确定的生存与Virulizin ®关联的预定义的病人亚群的利益。这些临床试验的设计将支持Virulizin ®批准下，我们与佐尔许可协议涵盖的地区（北美，南美，欧洲和以色列）。我们还认为，Virulizin ®在世界各地其他国家的强有力的伙伴关系的潜力。 Virulizin ®已被授予孤儿药物的地位和美国FDA和孤儿与欧洲指定医疗评估局（EMEA）的营销授权申请的治疗胰腺癌的快车道地位。 Virulizin ®是由多个专利保护，为全球的Lorus\'广泛的知识产权遗产的一部分。 发布时间：2009年11月01日 |
|
| 【推荐好友】 【发表评论】 |