Northwest Biotherapeutics yesterday announced its Phase III clinical trial for Glioblastoma multiforme (GBM) brain cancer has been adopted as a national priority trial in the United Kingdom under the adoption program managed by the National Institute for Health Research (NIHR), which is part of the National Health System in the UK. Constituting a significant validation, this adoption of NW Bio’s Phase III trial also carries with it resources and operational support for the trial sites.
The NIHR keeps a portfolio of clinical trials that have been adopted as high priorities for the United Kingdom. To be selected for the NIHR Portfolio, proposed clinical trials must undergo multiple layers of review and evaluation. Included in the evaluation is the potential significance of the new medical technology that is being tested, as well as the quality of the trial design, the feasibility of the trial and various other factors.
Trials selected for inclusion in the NIHR Portfolio are closely monitored by the NIHR, and trial sites receive various types of financial and operational support – for instance, the NIHR supplies resources and funding for additional staff at the trial sites, such as nurses, to aid in accelerating the trial. Additionally, the NIHR oversees performance of the sites, as well as imposing penalties on the sites if there are shortfalls, such as lags in enrollment.
“We understand that it is relatively rare for a small biotech company to have its clinical trial ‘adopted’ into the NIHR portfolio, especially a Phase III trial,” said NW Bio CEO Linda Powers. “This important validation of our trial is an exciting development, and the extra resources and support from the NIHR to the trial sites will be very helpful in accelerating our trial.”
NW Bio is a biotechnology company with its focus on developing immunotherapy products in both the United States and Europe that treat cancers more effectively than currently available treatments – on a cost-effective basis and without toxicities such as are associated with chemotherapies. NW Bio has a broad platform technology for DCVax dendritic cell-based vaccines. The company’s lead program is a Phase III trial in newly diagnosed Glioblastoma multiforme, which is the most aggressive and lethal form of brain cancer.
For more information, visit www.nwbio.com
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