腺病毒治疗脑肿瘤积极进行二期临床试验
2012-08-19 16:48:58   来源： 丁香园   作者：  评论：0 点击：

After seeing “tremendous efficacy” in aphase 1 study, a cancer drug firm is preparing for what it thinks will be aphase 2 pivotal study early next year of its virus therapy for brain tumors.

在1期临床研究中看到“巨大的功效”之后，一家癌症药物公司准备在明年初对其脑肿瘤的病毒疗法进行被认为是关键性2期临床的研究。

DNAtrix Inc.’s technology is an oncolyticagent, meaning it’s a virus engineered to destroy cancer cells in the body andleave healthy cells unharmed. When implanted directly into a brain tumor, thecompany’s adenovirus, Delta-24-RGD, invades and self-destructs tumor cells, andspills out to adjacent cells as the virus replicates. “What we think is alsohappening secondarily is that it destabilizes the tumor and may be initiatingan immune response,” said CEO Frank Tufaro.

DNAtrix公司的技术是一种溶瘤药物，即一种被 设计为可以在体内破坏癌细胞且不损害健康细胞的病毒。当直接植入脑肿瘤时，该公司的腺病毒Delta-24-RGD侵入肿瘤细胞并使其自毁，并且在病毒复 制过程中逸出并侵入相邻细胞。首席执行官Frank Tufaro说：“我们认为病毒继发还引起了肿瘤的不稳定和免疫反应的启动。”

Initially, the drug is being studied inhigh-grade gliomas, brain tumors that are rarely curable even with surgery,radiation and chemotherapy.

此药物最初在高分化胶质瘤中被研究，胶质瘤是一种难以用手术、放疗和化疗治愈的脑肿瘤。

Tufaro said the company saw “tremendousefficacy” in its phase 1 study conducted at MD Anderson Cancer Center fortreatment of malignant gliomas, with one patient in remission posttreatment.The DNAtrix team is now designing what it thinks will be a phase 2 pivotalstudy that it plans to take to the U.S. Food and Drug Administration and beginearly next year, he said.

Tufaro说公司在于Anderson博士癌症中心进行的恶性胶质瘤的1期临床研究中看到了该 药物的“巨大的效应”，一例患者治疗后缓解。他说，DNAtrix团队现在正在设计一项被认为是关键性2期临床的研究，这项研究计划将向美国食品药品监督 管理局提交并将于明年初开始实施。

It’s also doing scalable manufacturing inHouston and has recently raised some capital. Since its founding, the companyhas raised about $3.8 million in equity, Tufaro said, but was originallysupported by dollars from the National Cancer Institute. Venture firm DFJMercury and the Texas Emerging Technology Fund have also put money in thecompany.

此药物正在Houston批量化生产并且已经募集了一些资产。Tufaro说，自从其建立以来，公司已向公众募集了380万美金，但是主要靠国家癌症研究所的资金支持。DFJ Mercury风险投资公司和Texas新兴科技基金也向公司投入了资金。

Although DNAtrix initially plans to seekorphan drug approval for treatment of recurrent glioblastoma in patients, earlystudy results have suggested that the drug is definitely killing tumors, andthere could be other applications in other forms of cancer, Tufaro said. In thefuture, it may also test the drug in combination with chemotherapy. Tufaroestimates the company’s initial target market at about 20,000 patients a year,but the American Brain Tumor Association estimates there are more than 124,000people living with malignant brain tumors in the U.S.

Tufaro 说，尽管DNAtrix公司最初是计划寻找治疗复发性胶质母细胞瘤患者的有效孤儿药物，早期研究结果显示该药物在确切地杀死肿瘤，并且可能在其他形式的癌 症中有其他应用。未来还可能测试该药物与化疗联用的效果。Tufaro估计公司最初的目标市场是每年大约20000名患者，但美国脑肿瘤协会估计美国有超 过124000名存活的恶性脑肿瘤患者。

Researchers at Ohio State University arealso working on oncolytic virus technology for brain cancer, and severalcompanies are developing new brain tumor therapies as well. Roche is testingits cancer drug Avastin in brain cancer, and Northwest Biotherapeutics isenrolling patients in a phase 3 study of its DCVax-L immune therapy for GBM.

Ohio州立大学的研究者也在研究脑恶性肿瘤的溶瘤病毒技术，多家公司也在开发新的脑肿瘤疗法。Roche公司正在脑恶性肿瘤中测试其癌症药物Avastin，西北生物治疗公司正在招募患者进行针对胶质细胞瘤的DCVax-L免疫疗法的3期临床研究。

Brain cancer treatment is also the targetof several medical device companies including NovoCure, which had itsnoninvasive device approved last year for glioblastoma multiforme, and MonterisMedical, which developed a minimally invasive laser surgery for brain tumors.

脑恶性肿瘤也是多家医疗设备公司包括NovoCure公司和Monteris医疗公司的目标，NovoCure公司去年在多形性胶质母细胞瘤中验证了其非侵入性设备的疗效，而Monteris医疗公司开发了脑肿瘤的微创激光手术。

Some have hailed oncolytic virus technologyas one of most promising new strategies in treating cancer. Last year, Amgenshelled out $1 billion to acquire BioVex and its OncoVEX, a phase 3 oncolyticvaccine that’s being tested in melanoma and head and neck cancers. These kindsof drugs have a long history in cancer research, but many therapies in the pasthave failed because of safety issues and the inability to only recognize andkill cancer cells, Tufaro said.

一些人认为溶瘤病毒技术是最有希望治疗癌症的新疗法之一。去 年，Amgen公司投资10亿美元收购BioVex及其OncoVEX，OncoVEX是一种目前正在黑素瘤和头颈部癌症中进行3期临床测试的溶瘤疫苗。 Tufaro说，这类药物在癌症研究中有很长的历史，但是因为安全问题和不能仅仅识别并杀死癌症细胞，过去的很多疗法都失败了。

Founded by physicians and scientists atUCSF Helen Diller Comprehensive Cancer Center and MD Anderson Cancer Center,DNAtrix is stationed in Houston, Texas.

DNAtrix公司位于Texas州Houston市，由加州大学旧金山分校HelenDiller综合癌症中心和Anderson博士癌症中心的医生和科学家成立。