NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

Maybe the Germans are less discerning about value for money.

I doubt it!

Longfellow95,

I hope you can give me some information about the London-Chelsea REC.

This is from NHS Health Research Authority and i have a question about the REC reference (London - Chelsea Research Ethics Committee)

https://www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/dc-vax-brain-phase-iii-trial-for-gbm-current/

DC Vax-Brain Phase III trial for GBM- Current

Research type
Research Study

Full title
Protocol 020221: A Phase III Clinical Trial Evaluating DCVax®-L Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme

IRAS ID
131576

Contact name
Keyoumars Ashkan

Contact email
[e-mail]

Sponsor organisation
Northwest Biotherapeutics Inc

Eudract number
2011-001977-13

Clinicaltrials.gov Identifier
NCT00045968

Duration of Study in the UK
4 years, 6 months, 31 days

Research summary
The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(R)-Brain in patients with newly diagnosed GBM for whom surgery is indicated. Patient must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive standard of care, including radiation and chemotherapy (including temozolomide) and two out of three will additionally receive DCVax-Brain and the remaining one third will receive placebo. Patients randomized to placebo will have the option to receive DCVax-Brain in a crossover arm upon documented disease progression.

REC name
London - Chelsea Research Ethics Committee

REC reference
11/LO/0957

Date of REC Opinion
5 Oct 2011

REC opinion
Further Information Favourable Opinion

The following is from the RES Committee London-Chelsea Annual Report 01 April 2014- 31 March 2015 and the RES Committee London-Chelsea Annual Report 01 April 2015- 31 March 2016.

I wonder if you know what these amendments mean.

30 April 2014: Maybe it has something to do with Enhancements Of Phase III Trial of DCVax®-L For GBM Brain Cancer???
( NW Bio Obtains Approvals For Enhancements Of Phase III Trial of DCVax®-L For GBM Brain Cancer- https://nwbio.com/nw-bio-obtains-approvals-for-enhancements-of-phase-iii-trial-of-dcvax-l-for-gbm-brain-cancer/)

21 April 2015, 6 May 2015, 22 July 2015 and 12 August 2015: A lot of activity before the change in status of the trial??? (https://nwbio.com/nw-bio-confirms-phase-iii-trial-of-dcvax-l-for-gbm-brain-cancer-is-ongoing/)

London REC annual reports: April 2014 – March 2015

https://www.hra.nhs.uk/documents/630/ar-lon-chelsea-14-15.pdf

RES Committee London-Chelsea Annual Report 01 April 2014- 31 March 2015.

P.27

Table 10.2: Breakdown of current status of all modified amendments reviewed within the reporting period.

Favourable opinion timeline

Amendment REC Reference:11/LO/0957/AM08/1
Title: DC Vax-Brain Phase III trial for GBM
Version: Substantial Amendment 7
Date: 30/04/2014
Number of Days on clock: 5

London REC annual reports: April 2015 – March 2016
https://www.hra.nhs.uk/documents/702/ar-lon-chelsea-15-16.pdf

RES Committee London-Chelsea Annual Report 01 April 2015- 31 March 2016

P.22 and page 23

Table 10.1: Breakdown of current status of all substantial amendments reviewed within the reporting period.

Amendment REC Reference: 11/LO/0957/AM14
Title: DC Vax-Brain Phase III trial for GBM-Current
Version: Substantial Amendment 9
Date: 21/04/2015
Number of Days on clock: 6

Amendment REC Reference: 11/LO/0957/AM15
Title: DC Vax-Brain Phase III trial for GBM-Current
Version: Substantial Amendment 06
Date: 06/05/2015
Number of Days on clock: 11

Amendment REC Reference: 11/LO/0957/AM16
Title:DC Vax-Brain Phase III trial for GBM-Current
Version: Substantial Amendment 10
Date: 22/07/2015 19
Number of Days on clock: 19

Amendment REC Reference: 11/LO/0957/AM17
Title: DC Vax-Brain Phase III trial for GBM- Current
Version: Substantial Amendment 11
Dated: 12/08/2015
Number of Days on clock: 16