Phase III brain tumour study given safety clearance
A study of a new immunotherapy against one of the most hard to treat brain cancers has been given the all-clear in terms of safety.
Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and there are currently few treatments to halt its progress.
US biotech firm Northwest Biotherapeutics is developing DCVax, personalised immune therapy for this and solid tumour cancers, and has just been given clearance regarding safety from an independent data safety monitoring board. (DSMB).
The (DSMB) has made an unblinded review of the safety data of its international Phase III GBM Trial, and has recommended that the trial continue as planned.
However the board is still to release its findings of efficacy data, which is likely to be a make or break ruling on the drug.
Dr. Marnix Bosch, Chief Technical Officer of NW Bio noted: “We are pleased with the recommendation of the DSMB to continue the trial as planned. This is an important step in the ongoing progress of our Phase III trial.”
The Company has a broad platform technology for DCVax dendritic cell-based vaccines. The Company’s lead programme is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM).
The Company is also under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression. The Company also previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company also conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.
There have been few significant advances in treating GBM in recent years. Roche’s Avastin (bevacizumab) is approved in the US to treat the disease, but was rejected in Europe because of a lack of efficacy data. A study published in the New England Journal of Medicine in February this year found there was a four month improvement in progression free survival, but showed no survival benefit in adding the drug to first line therapy,
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