JFR, in reality DNDN developed Provenge many years ago and did get it through the FDA for prostate cancer. Unfortunately it was very expensive and not that big an improvement on the SOC and they went bankrupt as I remember it. They've come back I believe but demand is small, but they should be credited with being first. Our vaccine is far more effective and while the initial approval will probably be brain cancer, the tumor agnostic will certainly be discussed and off label use will become common and covered by insurance with sufficient anecdotal evidence.
The key is still gaining acceptance of the EDEN unit. Frankly I don't know if the EDEN unit could make Provenge, but it's a possibility, if it's price were lower perhaps demand would be greater.
I really can't say that vaccine alone will be curing cancer, but in combination with other therapeutics many more cures will be achieved. We often speak of cancer like it's one disease, we know it isn't. I believe that our vaccine will be more effective than many that don't actually use the tumor to make them, but rather pick specific targets, and mass produce vaccines intended for those targets. Certainly it costs more to make each batch of vaccine for a single patient, rather than mass producing for many, but with the automation we'll be able to achieve with the EDEN, it should be the superior product and therefore sales should be greater even at a higher price. Of course I could be wrong about this, if the generic vaccines achieve the same sort of T-cell responses, they could surprise.
I just heard of someone who had a bone marrow transplant, but I really don't know if any marrow was actually transplanted. Bone marrow was truly transplanted years ago, but it was the stem cells in it that were doing the work. I had stem cells for leukemia, I doubt if any marrow was processed at all, though it's the choice of the donor, it's faster and more painful getting the stem cells out of the marrow, the other choice is spurring extra stem cells which can be harvested, like doing leukapheresis from the bloodstream. It takes longer, but has little pain involved. I was told most people do it that way. I don't know if any disease actually requires the marrow to be transplanted, and when the stem cells are transplanted they don't target them into the marrow, they just put them through the same catheter that other IV liquids come in through. It was somewhat fascinating watching my blood counts come up after the transplant, for a few days there was virtually no count, then gradually the numbers came up a little higher each day. In my case on day 19 I was allowed to go home by a substitute for my Dr. who headed the Dept, but would have held me longer. Initially I had to return twice a week, as they're very concerned about rejection, then once a week, now after nearly a decade I'm still there quarterly as I only recently came off pill chemo.
I actually hope that DCVax-Direct is eventually found to be the answer in certain cancers, without surgery. If it's proven to provide cures to people with inoperable tumors, why not use it before surgery and if the tumor dies out completely, hopefully in time the bloodstream will eventually dispose of the dead matter. I don't know that this is possible, but as I understand it one of the longest living patient from the trial of direct had pancreatic cancer and was still alive the last time the data was updated. I certainly don't know if anyone from the trial is still alive, and if they are, do they still have observable cancer, or are they deemed to be cured. It's a shame that NWBO didn't have sufficient funds to bring both products through clinical trials simultaneously. Hopefully later this year DCVax-Direct will be back in the clinic.
To me, one of the saddest things about the way we develop new drugs is the time from genesis to approval. The preclinical work can take a decade before it sees the first patient in Phase 1, then a decade or more as it moves into a pivotal trial, then years to develop a BLA or NDA and finally at least 6 months to review it. I actually took a drug where in Phase 3 they ended the trial early as they recognized it was saving life in the form of leukemia I had, that was Gleevec. Decades before I remember following it and saying it was a miracle drug for the maker as remissions were sustained as long as people took the drug. Without stem cells I'd have done that, but even after them I was kept on the third generation of Gleevec because it was still possible to come out of remission. My original oncologist actually didn't want me to get stem cells on the initial remission, as that too is risky, but I was shown reports indicating a high percentage coming out of remission and spoke with the head of hematology at UCLA about a much younger patient who they didn't think they'd get into a second remission. You must be in remission to get stem cells. I met the head people at both UCLA and City of Hope and decided on COH, but I'm sure UCLA would have been fine as well. I liked the fact that COH specialized in cancer while UCLA treats everything. I really liked the feeling at COH, I'd be willing to bet that back in the Phase 1/2 period for Gleevec it was seen to work, why shouldn't it have been discovered and approved back then. Many products can be seen to be miracles, yet nearly all must go through a couple decades in development, there should be a better way of handling this.
Gary
