We're heading into a 4 day trading week that just might be the greatest in our history, or it could bring nothing really new, we won't know until things just happen. What could possibly happen. The release of the Journal and/or the official TLD statement. An announcement of the Experts Theater presentations, and possibly some indication of what will be presented there. Finally, just the simple anticipation of ASCO and what's expected at this massive conference that's purely based on oncology.
Many investors here and elsewhere tend to look at nearly all treatments for cancer as Chemo, of course they aren't, but I really don't know if we'll ever be so successful with other treatments that anything that truly is chemo can be eliminated. I believe that DCVax-L is a major stride forward that may have benefits in many cancers, but one of them most certainly will be making other therapeutics more effective, and that includes those that truly are chemo's.
It's been over a quarter century since my wife's successful treatment for breast cancer. In her case the Dr. believed she got all of the cancer, but surgery was followed by radiation and chemo to be certain. I believe that today the treatment would be much the same. I can't say that refinements haven't improved what's done, but my point is that Doctors can't be certain they got everything, so radiation and chemo follow.
I don't know what percentage of breast cancer patients are cured by this initial treatment, but for the sake of discussion let's say it is 75%. Now let's say that we wished to try DCVax-L against breast cancer, but only in patients where the Dr. believes all cancer has been removed. Do we abandon the radiation and chemo and only use DCVax-L and see what happens, or do we add it to the existing protocol. I suspect most regulators will want it added to existing therapies. If in reality DCVax-L could be more effective than the current protocol with no radiation or chemo, the only way we'll ever know it is if patients demand to be treated that way, and anecdotal evidence proves it's true.
In both my wife's case, and my case with leukemia, either of us could have told our Doctors that we wanted nothing more after her surgery, or my stem cells, and the Doctors would have permitted it, but it would be against their advice and statistically our odds of survival would be dramatically reduced, but some people do it. Such people might be great subjects for a trial with DCVax-L if that was their choice, but only if they did it by choice. If my 75% was a correct figure and the addition of DCVax-L increased the outcome to 80%, some would say it isn't that much, on the other hand it's a 20% improvement, I have little doubt that it could be approved. Of course we'd love to hear that no one came out of remission once treated with DCVax-L, but that's doubtful.
A totally different approach might be taken with breast and other cancers, don't add it to the treatment after it's surgical removal, but hold the tumor properly and only make the DCVax-L if the cancer comes out of remission. I'm not suggesting this, just pointing out a different approach if normal treatment failed. Regardless of how it's done, for the cancers that kill slowly, the trials could take decades to get really significant data.
I would hope that the regulators would consider the use of DCVax-L in solid cancers if we took on another really deadly solid cancers and proved it's efficacy. I would think that positive data in pancreatic cancer would impress the regulators. I don't know, but if a method could be found to remove sufficient lysate from patients with pancreatic cancer not eligible for the Whipple procedure it would really be impressive if improvement was clearly being seen. This would also be a great place to test DCVax-Direct if it's impossible to make DCVax-L.
I would love to see the regulators just say DCVax-L may be utilized in all solid cancers based on the GBM trial, I just don't believe any of them would take that large a step forward. I frankly doubt it even if we took on pancreatic as well. Perhaps the answer will be tons of anecdotal evidence where Doctors and patients agree to give it a try and success is seen in many cases.
Gary
