We got out of MSKCC in record time again yesterday and made the 4:40 Virgin America flight out to SFO. Nick is doing fine and we are now waiting on the final results of the Blood, Urine, and Bone Marrow tests. The SCANS are NED!! Woo Hoo on that. Kushner just emailed me minutes ago.
Nick crushed us Tuesday night by demanding Chinese food. He turned down, Campagnola, Scalinatella, Wolfgangs, and others so we had to walk from 64th & 3rd to 39th & Lex and go to the "Green Awning" place by our old hotel. The food is OK but the place is nasty!! It was dirty two years ago and it hasn't gotten any cleaner....oh well! He enjoyed it.
While in New York, I attended a meeting with the Band of Parents board and Dr. Cheung, Dr. Kushner and Dr. Modak. Bottom line, they have amazing treatments that they are working on that the BOP and many of you have helped fund. The following is an email update that was sent to all the parents that make up BOP.
============================================================
Dear Families,
Several board members traveled to New York for a few hours Monday night for our semi-annual board meeting with Dr. Cheung. Dr. Kushner and Modak were also there.
The news is all good! While we are waiting for the manufacturing and testing phase of the HU/CH3f8 project to come to the clinic and in children he had several things to explain to us that are going to be starting in the next few months!!! Here is a "simple" summary of our meeting.
Dr. Cheung was very encouraged with the progress that has been made on the humanizing project. He had a general timeline on a power point slide. He told us a year ago that it would take 1-2 million dollars to get the antibody into testing phase and he is going to be right on target. He is testing not only the Humanized version, but the Chimeric version too. There are 4 humanized constructs and two chimeric he will test. The one that yields the best results is the one that will go into production. This antibody should be in the prototype phase in the next 8 weeks. Dr. Cheung should have a manufacturer picked out and the production, testing and manufacturing stage will then begin. This is the longest phase and he anticipates the drug to be in our children by the last quarter of 2010. This seems like a long way away but in the drug development business it is really pretty remarkable.
In the meeting Dr. Cheung kept emphasizing that we should not stop at the humanized 3f8. He wants target treatments so that our children, especially relapses, will have an arsenal of weapons to attack. It is BECAUSE of the BAND OF PARENTS and their efforts that he is able to move forward on new treatments that may have been much longer in coming. We need an arsenal and we're going to work hard to build the weapons!
All of his efforts are focused on approaching the disease with multiple options because EVERY child has different responses to different treatments. In that light he proceeded to explain several other things he would like the Band of Parents to consider.
1. The regular 3f8 dosage will be escalated 4 times the current dose for standard therapy with a target date of 6 months from now. It is a matter of having enough money secured to open the trial. This will be available for relapses who don't have hama and as the standard therapy. This new dosage allows higher levels of saturation of 3f8. So, in essence one round will be a powerful punch 4 times more potent that the current therapy. The challenges is... it is a lot of antibody and needs a lot of ONGOING funding. Here are the numbers.
Now $500.000.00 covers 80 children for 3f8With the high dose as the standard that number drops to 20 for the same money. They are looking for long term funding of this project. The advantage of the high dose is that hama chances are reduced and the effectiveness appears to be increased. This will be available to relapse patients as well who are not hama positive. It will also be the frontline antibody therapy.
2. 3E7 antibodyDr. Cheung was very excited to talk about this really promising therapy. It is an antibody that was explored twenty years ago at another research facility for other cancers, specifically ovarian cancer. The funding could never be completed but the clinical data was very encouraging and was found to be a good antibody for neuroblastoma. Dr. Cheung strongly believes there is a lot of promise in using this antibody in our "arsenal". Here are his reasons.a. It enters the neuroblastoma cells and infiltrates instead of attach to NB like 3f8b. Because it enters the cells agents can possibly be attached to it which can kill the cells.c. It inhibits proliferation of tumor cellsThere were several other very technical things it does.. all good but complicated to explain! The bottom line is that this is the first antibody besides 3f8 that has a completely different way of attacking the tumor cell. Dr. Cheung had a timeline for this project and a projected cost.He hopes to have it funded and in the clinic in trial by end of 2010Funding needed 1.8 million
3. NKcell strategy with 3f8This would be a relapse option and could be in trial very soon. We don't need to fund this, except for the ongoing 3f8 money. It has been used without 3f8 with leukemia with success so we are just piggy backing on their trial.
A donor would be used to harvest the NK cells on the machine that harvests stem cells. The cells would then be implanted into the patient. The next week the high dose 3f8 would be administered.Their belief is that the 3f8 after the NK cells are implanted would enhance and "fix" what 3f8 alone perhaps didn't do with relapse.
The high dose 3f8 and the NKcell with 3f8 could be starting in the next few months.The HU/CH3f8 is projected to be in the clinic by the last quarter of 2010 if all continues to on target.The 3E7 if funded would also be projected to be in the clinic by last quarter of 2010Please keep in mind that all of these are timeline goals and actual dates can't be assessed.
Now... the VACCINE!Band of Parents has nothing to do with the vaccine. We did ask about it though. It is sitting on the shelf packaged and ready... The internal review Committee at Sloan is meeting next week (July 22nd), and if everyone is comfortable, the protocol will be submitted to FDA. Upon submission, the FDA has 30 days to say "no" to the trial going forward if they have any concerns. So it looks like we are looking at vaccine to start some time in the next couple of months. The vaccine will be ready for relapsed patients who are in a second remission or a case by case scenario. The vaccine trial is a 6 month trial. You get 7 injections with lots of blood work in those 6 months. It is not an iv it is an injection. They are in the process of assembling a list of those patients they believe will most benefit from the vaccine.
So the bottom line is.... the Band of Parents has a great opportunity to move forward and continue to build the arsenal of weapons that Dr. Cheung believes will give many more kids many more options with low toxicity and lots of hope! We need to start a converation among our members as to how best to raise the next 3 million dollars in the next two years. We have pledged to the hospital to finish the last phase of the HU/ch3f8 project as soon as he has a signed contract with the company that will start the production of the project That pretty much uses up the money raised to date. If we help out with high dose 3f8 AND fund a large portion of 3E7 we need some huge donors and huge help!
We need to regroup and refocus and target our money to the next things that Dr. Cheung has on the table.... High Dose 3f8 and 3E7. Please comment and give us your thoughts on how to do build our options quickly!!!!
Thanks so much, Your board of directors
