综合生物谷、丁香园消息，据美国知名电视新闻栏目《60 分钟》报道，美国杜克大学的Gromeier开发的利用基因工程改造过的脊髓灰质炎病毒治疗恶性胶质瘤的疗法获得了FDA的突破性疗法认证。FDA 的突破性资格将大大加速开发的进程。该项研究移除病毒部分遗传物质，使其可以特异性的在恶性胶质瘤细胞中增殖但并不影响周围健康组织的生存。
原文：Duke’s oncolytic virus study gains FDA Breakthrough: CBS
After tracking an early-stage academic research project that uses a genetically engineered form of the poliovirus to help shrink certain brain tumors for a year, CBS’ 60 Minutes reports that the treatment has now been given a “Breakthrough” status from the FDA.
The topical TV news program has reported that Duke University’s Dr. Matthias Gromeier has been given the Breakthrough status for his studies in patients with glioblastoma--a particularly aggressive brain cancer with high mortality rates and few effective treatments.
In a Phase I study Dr. Gromeier--a molecular biologist at Duke who has been working on the treatment for quarter of a century--removed part of the virus’ genetic material so that it would not kill healthy cells, and then multiply in only cancer cells, thereby, the theory goes, killing the tumor but leaving surrounding tissue alone.
Last year, the university reported some success in this approach, with early-stage results reported in March 2015 showing that while 11 of the 22 patients treated by that point had died, the other 11 saw their tumors shrink, with three featured in a 60 Minutes report being at the time free of cancer.
This treatment works with just one dose and is designed to keep attacking cancerous cells until they are destroyed.
Cue 60 Minutes throwing the words “miracle” and “cure” around, declining to add that necessary caveat that this is early-stage research that still requires many more years and many, many more patients before efficacy can truly be found and proved.
It’s also of course not the only group looking to use oncolytic viruses as a form of immunotherapy in cancer research. Back in October last year, Amgen ($AMGN) gained FDA approval for the first oncolytic virus-based drug Imlygic (talimogene laherparepvec), which gained the U.S. regulator’s approval for the treatment of melanoma lesions in the skin and lymph nodes.
Amgen gained access to the drug, which uses a re-engineered form of the herpesvirus, in 2011, when it paid $425 million--plus $575 million in potential milestone payments--to acquire Imlygic from its original inventor, Biovex.
Amgen’s drug however had a rocky road to approval with several trial hiccoughs, and is estimated by analysts to only make around $200 million a year in peak sales.
A handful of other smaller biotechs, such as Canada’s Oncolytics Biotech and the Pink Army, founded and run by former Amgen scientist Andrew Hessel, are also looking to create similar therapies.
But many of these drugs are now also being tested alongside other immunotherapies, such as checkpoint inhibitors, to expand efficacy.
This is in fact true of both Amgen and Oncolytics, which have both (separately) teamed up with Merck ($MRK) and its checkpoint inhibitor Keytruda in a Phase III and Phase I test respectively.
A Breakthrough from the FDA greatly speeds up the development process and will be a boon for the researcher and the university. In more practical terms, it will also likely see a greater interest from investors to help push studies into the tougher and pricier realms of mid- to late-stage studies.
The news is being reported by CBS, but details have not been released by Duke University. Its flagship program 60 Minutes said it would provide a further update on Sunday.
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