瑞士已批准西北生物治疗(NorthwestBiothera—peutics)公司的世界首个治疗脑癌疫苗(vaccineforbraincancer)上市．商品名为DCVax-Brain。脑癌可能发生在人各年龄段，是20岁以下儿童癌症死亡的主要原因。脑癌是致死最快的癌症：治疗受限，即使新诊断出的患者平均存活率仅14．6个月。
在临床研究中，新诊断出和复发的患脑癌者用DCVax—Brain脑癌疫苗治疗后的存活期(新诊断出的患者超过33个月．因仍存活着尚未获得中位数数据)是未采用DCVax—Brain脑癌疫苗治疗患者的2倍。此外，采用DCVax-Brain脑癌疫苗治疗与化疗不同：不产生任何使患者衰弱的不良反应。瑞士当局同意该公司在美国生产DCVax-Brain脑癌疫苗，在瑞士选择的医疗中心治疗脑癌患者。
西北生物治疗公司的DCVax是一可望应用于大多数癌症的技术平台。
DCVax通过调动所有免疫反应：
先天的和后天的，而不是仅单一抗体或单一T细胞的单种免疫剂。如此．DCVax以自然途径调动患者的免疫系统使其功能恢复至正常．这从两方面来提高疗效而无毒性问题。与普通抗癌药不同，DCVax不造成任何使患者衰弱的不良反应。
DCVax药品个性化用药．由从患者自身肿瘤获得或显示的癌症标记结合患者自己的主免疫细胞(树状细胞)制成。主免疫细胞的前体持续在患者血液中循环，通过血液抽提获得。此主免疫细胞通过一系列专利技术步骤使其成熟和激活，随后通过接触患者肿瘤生物标记”教育”后对臂或大腿皮下简单注射几滴即可再返回患者体内。与许多正在开发的个性化治疗不同．DcVax为低本高效(cost-effective)。
西北生物治疗公司历经10年的开发，采用批量生产工艺(单批生产至少可供特定患者治疗3年的疫苗)专利是低本高效的关键。药品单剂瓶装冷冻储存，易于使用。此种储存高度可靠和成本低。该公司还正在美国对141例患者进行关键的Ⅱ期临床研究，希望2009年初在美国和欧盟获准上市。届时，作为罕用药品的DCVax-Brain脑癌疫苗在美国和欧盟分别有7年和10年的专卖权。
DCVax®-Brain
DCVax®-Brain is an experimental autologous cellular therapy designed to create a specific immune response against a patient’s cancer. DCVax®-Brain utilizes a patient’s own dendritic cells (DC), and an extract of the patient’s own tumor cells to achieve an immune response. The tumor from surgery is shipped to a manufacturing facility, as are blood cells, in order to prepare the DCVax®-Brain. DCVax®-Brain is then shipped frozen to the clinic for administration to the patient. DCVax®-Brain is usually manufactured in sufficient quantities for treatment of at least one year, and often for two or more years.
Brain Cancer Facts
Brain cancer is diagnosed in about 200,000 patients per year with approximately 40,000 being primary brain cancer, and the remainder the result of metastasis from other distant primary cancers such as breast, lung and colon. Approximately 60% of brain cancers are diagnosed as astrocytoma of which there are four forms, grade I through IV. Glioblastoma multiforme (GBM) is the most aggressive and lethal form of astrocytoma and is classified as grade IV. Brain tumors are the leading cause of solid tumor cancer death in children under the age of 20.
Glioblastoma multiforme represents about 50% of the astrocytoma, and is the most lethal form of brain cancer for which there are currently few treatment options that significantly influence disease outcome. In the United States, the incidence of GBM is about 10,000 -12,000 cases per year, prevalence is approximately 25,000, and there is no gender or age bias as well. Worldwide, the incidence and prevalence is approximately double that number. Survival at one year is about 28%, at two years 8% and at five years < 3%.
Standard of Care
Patients newly diagnosed with GBM are generally eligible for surgery, and following surgery receive a regime of external beam radiation therapy with a median survival outcome of about 10-12 months. Over the last two or three years, several chemotherapy drugs were approved as adjuvant therapy to surgery and radiation. First is the Gliadel Wafer that is inserted into the cranial cavity at the time of surgery, and which continuously, and locally delivers the chemotherapeutic agent carmustine over the next several weeks to the remaining tumor cells in the cranium. Studies by Brem et al show a survival advantage of about 2 months, survival improving from a median of 10.1 months for surgery + radiation to 12.6 months for surgery + radiation + Gliadel Wafer. The second approach uses the drug temozolomide following surgery, and concomitant with radiation and post radiation. This regime showed a survival advantage also of about 2 months, from 12.1 to 14.6. Clearly, there is an unmet medical need for improved treatment outcomes for patients with GBM.