Next updates expected between now and the end of January:
* Opening German Clinics for L.
*Opening European Clinics for Direct.
* Initial data regarding Direct's efficacy on first 2 or 3 patients.
* Recommendations from Review board on DCVax-L.
A few things we know/believe from various sources.
1. Germany is still gearing up for opening its clinics/manufacturing/quality control/compassionate use for DCVAX-L -- should happen any day.
2. The Brits are up and running their DCVAX-L phase III trial, manufacturing and parallel compassionate use program.
3. Sarah Cannon -- and perhaps MD Anderson's European sites -- are preparing to begin DCVAX-Direct trials.
4. The equivalent of a less potent version of DCVAX-Direct was used successfully on 10 Humans -- (not just mice)--patients in the Triozzi study way back in 2000, and an amazing 6 out of ten very sick patients had tumor reduction and signs of immunity. In that study, Triozzi amazingly held off on using that product at that time in favor of scientists developing a more "potent" version through development (think about that for a moment). 11-13 years later, NWBO announced through patents, press releases and presentations that it has that more potent version.
5. DCVax-L reached its first interim event juncture when NWBO thought it would. Because NWBO is using a better trial design in phase 3 that allows them to exclude post radiation patients with concurrent tumor progression, we might, might, might submit that the first event juncture and timely prediction thereof was predicated almost exclusively on control arm events. Whereby the trial arm might benefit far more than the control arm ( as anticipated based upon our understanding of past preclinical, clinical and third party experience/results) from the synergistic advances of improved near total tumor resection, chemotherapy/radiation and undetectable tumor progression in the selected patient population at the moment DCVAX-L/placebo treatment is initiated.
