Heavy! FDA grants Tocagen the status of orphan drug for the treatment of malignant glioma
August 27, 2015 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Malignant glioma is the most common type of brain tumor, which is extremely bad. More than 10,000 patients in the United States suffer from this disease every year. Due to current treatment conditions, the 5-year survival rate of malignant glioma is less than 5%.
Tocagen CEO Harry Gruber said that the company has been committed to the development of new brain tumor treatment drugs, the FDA grant Toca 511 and Toca FC joint therapy orphan drug status, which has a crucial impact on the company's strategic development.
In this combination therapy, Toca 511 is a retroviral replication vector that selectively delivers the gene for cytosine deaminase (CD) into cancer cells. After Toca511 is spread over the tumor, cancer cells that express the CD gene can convert fluorocytosine (5-FC) into the anticancer drug 5-fluorouracil (5-FU), which in turn mediates tumor cell programmed cell death and enhances the body. An immune response to a tumor.
It is reported that Toca 511 and Toca FC combination therapy will be launched in Phase II and Phase III clinical trials this year. According to the clinical interim report, the median survival rate of patients with malignant glioma after the combination therapy is 13.8 months, which is better than 7 months. The mid-term survival rate historical benchmark showed good clinical efficacy.
Last year, Tocagen and Siemens Medical Diagnostics reached a strategic cooperation and jointly developed a companion diagnostic test system, which is also reported to be used in this clinical trial.
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