This has positive implications for ICT-107....Phase 1/2 DCVax-Direct clinical trial will not be blinded
This has positive implications for ICT-107: News has come from Northwest Biotherapeutics (NWBO) on its DCVax® personalized immune therapies for solid tumor cancers. The information is an announcement that Phase 1/2 DCVax-Direct clinical trial for all inoperable solid tumor cancers, which is planned to begin within approximately the next sixty days, will not be blinded. This means that the results will be seen as the trial proceeds. Knowing that an efficacy endpoint is tumor shrinkage or elimination), this trial is expected to yield meaningful ongoing results by the second half of 2013......DCVAX is also available for compassionate use in Europe and will probably gain that status in the US shortly
This innovative clinical trial is approved by the FDA for all types of solid tumor cancers (i.e., cancers in any tissues of the body), and is configured to provide rapid results....... DCVAX is also available for compassionate use in Europe.
Jeff, the trial doesn't have a control group so there is no need for them to blind the results. However, I would tell you that we are completely blinded. The trial has been going on for years and we still don't know where they are with enrollment other than between 0 and 312 patients. Before this update, we were supposed to hear results, not completed enrollment, but results in June. Before that, it was one date, before that it was another date. So despite the fact that you have heard that the results will not be blinded, I can tell you that I am completely blind in terms of where they are in the progress of their trial.
Based on the science IMUC should be better due to the targeting of the DCs for the CSCs.....They should be able to combine there 107 and 121, as well and it the DC CSC approach could apply to 80% of Solid Mass Tumors......I started investing in IMUC and IMUC CALLs after three highly respected MD PHDs told me that ICT-107 was revolutionary..... This was about 8 months ago..... I have been following the progress for the last 2 years..... A couple comments: It would seems that orphan drug approval and compassionate use would be awarded with a 6 plus month OS advantage along with a P3 Study. The P3 may not be a randomized/placebo, if the data demonstrates 12 plus month increase in OS PFS. Also this Particular DC-CSC Therapy could....ie all the ICTs could apply to 80% of cancers..... the non-clinical OS for Standard of care for GBM is still around 11-13 months.....I understand that the SOC OS will likely be 18 to 19 for this study.....I do not see any reason to use RT and TMZ in future care....apply the ICTs as quickly after surgery as possible to avoid massive up regulation of growth hormones during the post surgery healing process....the ICTs DC-CSC therapy will also likely to be combined with each other and other immuno-stimulants and other adjuncts, which would further increase PSF and OS Less
This design will not pass muster on this side of the pond. The EU can give limited approval after PII (CE Mark)
but, again, the trail design is not optimal for this. At any rate, the biggest problem for NWBO is a debt that is almost 20% larger that their market cap! They recently did a reverse split to try to gain investors but, as is usually the case w/a R/S, it lowered the market cap even more. If this co. survives, it will probably be at the expense of the current investors - again.
Todays press release by NWBO is just another example on what kind of company they are. They try to make themselves look good by trying to throw other companies under the bus and in turn it just looks bad upon themselves. You have to take the high road if you are running a reputable company.
If you read the Seeking Alpha articles on NWBO its clear that the CEO is in this game for keeps and is willing to use her own money to float the boat for as long as it takes.This incredible faith in the vaccine is impressive.