Replies to post #93984 on NorthWest Biotherapeutics Inc (NWBO)

[H2R]

Embargo mis-handling?

I've worked with World Organizations in Geneva (WTO, WHO, etc.) and before they let anything out on their sites, they first write things up in an embargo section (like a WTO internal section if you want), to be reviewed and finalized. Then they PR as the articles are made public.

I'm just wondering if this is something similar here. Not sure how well you start setup a clinicaltrials entry privately before making it public.

Just a thought...

[Smokey21]

I suspect they will put out the PR when they have good news on the current L trial to combo up with it, or something on the financial front, like maybe some up-front payment from BMY for exclusivity on rGBM indication. Or perhaps they are waiting on the trial to be recruitable.

[sharpie510]

Looks like DCVax-Lung & DCVax-LB were coined by NWBO back in 2002.

http://www.biocentury.com/weekinreview/clinicalstatus/2002-11-11/dcvax-lung-ind-withdrawn-257860

http://www.wikinvest.com/stock/Northwest_Biotherapeutcs_(NWBO)/Dcvax%20-lung%20-lb

This excerpt taken from the NWBO 10-K filed Apr 17, 2007.

DCVax®-Lung/ DCVax®-LB

DCVax®-Lung. was designed to use our DCVax® platform in combination with isolated and deactivated lung cancer cells as antigens. Although we received clearance from the FDA to conduct a Phase I clinical trial to assess the safety of DCVax®-Lung, due to lack of financial resources, we suspended the initiation of this trial.

DCVax®-LB is a further extension of the DCVax® platform for the treatment of resectable solid tumors. Like DCVax®-Lung, DCVax®-LB uses autologous DC pulsed with isolated and deactivated tumor cells for the formulation of the treatment. In addition, the autologous DC used to formulate DCVax®-LB are activated (or matured) with heat-killed and formalin-fixed BCG mycobacteria, analogous to the activation process used in the manufacturing of DCVax-Prostate. We have filed an Investigational New Drug application (IND) containing a protocol for a Phase I trial in non-small cell lung cancer with the Food and Drug Administration (FDA); this IND was cleared to proceed by the FDA in the first quarter of 2006. This clinical trial has not yet been initiated.

Target Market. The American Cancer Society estimated that 213,380 new cases of lung cancer would be diagnosed in the United States during 2007. Approximately 80% of these cases are expected to be attributable to non-small cell lung cancer, the indication we were targeting with DCVax®-Lung and are now targeting with DCVax®-Direct. Deaths from all forms of lung cancer are estimated at 160,390 per year for 2007.

Current Treatments. Existing treatments for non-small cell lung cancer include surgery and radiation therapy, which are used in various combinations. These treatments have significant adverse side effects. In its most recent study, the National Institutes of Health reported that the 1989-1996 five-year survival rate for non-small cell lung cancer patients was only 6.2%. Following initial treatment, virtually all cases of this cancer recur, with a life expectancy of approximately one year following recurrence. No effective therapy exists for these patients.