NorthWest Biotherapeutics Inc (NWBO)

[maverick_1]

KEY BASIC concern on CAR T:

A downside to CAR-T therapies is that they’re linked with cytokine release syndrome, an immediate complication that can be fatal to patients. In April 2014, Juno was forced to halt its clinical trial of aggressive non-Hodgkin’s lymphoma following the deaths of two patients due to cytokine release syndrome. Juno’s clinical trials since resumed

from: http://www.dddmag.com/news/2015/08/patient-death-unrelated-clinical-trial-says-kite-pharma

Obviously not an expert but:

PERHAPS the following situations may help:
1.Juno's trial had deaths as cited above BEFORE the most recent ones which have been resumed and cleared by FDA.
2. Kite's
3. CYTR did have a clinical halt in 2015 due to a death but did resume their Ph3 which was reported AH Monday.
http://www.prnewswire.com/news-releases/cytrx-announces-partial-clinical-hold-affecting-aldoxorubicin-clinical-trials-283026111.html
4. New Details Emerge About Clinical Trial Tragedy In France with Good overview in Europe's EMA:
http://cen.acs.org/articles/94/i4/Early-Phase-Clinical-Trial-Leads.html

A spokesperson for the European Medicines Agency told C&EN that, “since 2007, approximately 12,500 Phase I clinical trials have been conducted in the European Union without any major incidents being reported.” The last major Phase I clinical trial catastrophe took place in London in 2006, when six healthy men suffered permanent organ damage, and the loss of fingers, from unanticipated severe immune reactions during testing of an arthritis and cancer drug candidate called TGN1412.