NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Well. Expert horizon-scanning bodies like the NIHR in the UK and PCORI in the US, clearly believe that DCVax-L has disruptive potential.

NIHR in the UK.

Press Release- April 16, 2013.


NW Bio’s Phase III Trial With DCVax®-L For Brain Cancer “Adopted” As A National Priority Trial In UK.

Trial Sites Will Receive Support from UK Health System.

BETHESDA, Md., April 16, 2013 — Northwest Biotherapeutics (NASDAQ: NWBO)
(NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that the Company’s Phase III clinical trial for Glioblastoma multiforme (GBM) brain cancer has been “adopted” as a national priority trial in the UK, under the
“adoption” program managed by the National Institute for Health
Research (NIHR), which is part of the UK’s National Health System.

This “adoption” of the Company’s Phase III trial constitutes a significant validation, and also carries with it resources and operational support for the trial sites.

The NIHR maintains a “portfolio” of clinical trials that have
been “adopted” as high priorities for the UK. In order to be
selected for the NIHR Portfolio, a proposed clinical trial must go
through multiple layers of review and evaluation. The evaluation includes the potential significance of the new medical technology being tested, the quality of the trial design, the feasibility of the trial, and numerous other factors.

Trials that are selected (“adopted”) for inclusion in the NIHR Portfolio are monitored closely by the NIHR and the trial sites receive several types of financial and operational support. For example, the NIHR provides resources and funding for additional staff (e.g., nurses) at the trial sites to help accelerate the trial. The NIHR also oversees the performance of the sites, and imposes penalties on the sites for
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,” noted Linda Powers, CEO of NW Bio. “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.”

https://nwbio.com/nw-bios-phase-iii-trial-with-dcvax-l-for-brain-cancer-adopted-as-a-national-priority-trial-in-uk-2/