Interim results
The virus has been designated a breakthrough therapy in Japan.
An interim analysis of a trial of the oncolytic herpes virus G47∆ has shown a 1-year survival rate of 92.3% in 13 patients. This was significantly higher than 15%, the preset control value based on meta-analysis of historical data.
This outcome of the phase II trial was reported at the 24th the Society for Neuro-Oncology, #SNO2019, from November 22 – 24, 2019. The study of G47∆ was performed at the University of Tokyo, Japan.
How was the treatment given?
The researchers administered of G47∆ into the tumors of patients with recurrent or residual glioblastoma, every 4 weeks, for the maximum six times.
In most patients, G47∆ was given in addition to maintenance chemotherapy using Temozolomide, Temodar.
The primary endpoint of the study was the rate of 1-year survival and it was achieved big time!
The injections were well tolerated.
Why was the study stopped?
Statistical significance was above the criteria of early termination, so the trial was terminated early and considered the pivotal study for the new drug application.
G47∆ has proven safe even when injected repeatedly, six times into the brain. Two patients experienced severe fever related to G47∆.
About Glioblastoma
Glioblastoma Multiforme, or GBM, is a type of cancer which originates in the brain and made of brain cells known as “gliomas.”
Gliomas are neuron supporting cells, constituting a part of the nervous system.
Glioblastoma tends to develop into a star shaped formation. They are particularly aggressive tumors with the potential to grow fast and spread to other parts of the brain relatively quickly.
Glioblastoma creates its own independent blood supply which feeds it, promoting its growth and even enabling it to invade additional areas of the brain and establish more foci, hence the name “multiforme.”
GBM is a stage 4 cancer and constitutes about 50% of all brain tumors among patients aged 18 and older. Glioblastoma does not metastasize outside the brain.
The existing standard therapies used for glioblastoma are not curative, and this is a source of the need for innovative and effective treatment strategies in order to fight the disease.
The National Cancer Institute, NCI, highlights the fact that for a certain group of glioblastoma patients, the best treatment option is to join one of the many clinical trials existing worldwide aiming to increase their chances of therapeutic success.
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