Replies to post #11451 on NorthWest Biotherapeutics Inc (NWBO)

[BioInfo]

FDA clearly states this:

The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.

Detailed Description:

Patients who are being screened under protocol 020221 who are not eligible for enrollment due to a) evidence of disease progression or pseudo-progression post chemo-radiation or b) insufficient (<5 doses) vaccine manufactured, and for whom the DCVax-L treatment was manufactured and released are eligible for this study.

Treatment Schedule:

Open label vaccine injections will be give per the associated 020221 protocol. Injections will be given at days 0, 10, 20, and at months 2, 4, 8, 12, 18, 24 and 30. There are no therapeutic restrictions, but guidelines for drug administration are recommended as per the 020221 protocol.

Data collected includes vaccine administration information, and any vaccine related adverse event. Patient MRIs will be collected centrally for future review. Patients will be followed for disease progression and survival.


Wow, even those who had insufficient doses are now being allowed to receive vaccine. you would think this only happens when the therapy is working, they are allowing everyone a chance to get the therapy.

[Pyrrhonian]

I think it would affect the current subgroup(s). It is open-label, but so are all crossovers. It's interesting they mention pseudo progressives there. They are almost surely one subgroup in the L-trial.

One thing's for sure--they wouldn't do this as a study if they weren't going to use the data in some way important to the L trial.