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03/21/17 VBI Vaccines Building On Duke University Research for New Cancer Therapy
This is an exciting new treatment. IF it is true that most GBMs have the CMV virus, this vaccine should work. As I mentioned in recent stories, it is controversial if that is true. A few researcher say almost all GBMs have it and a few others say NO GBM have it. If this vaccine works, it is more proof of that theory.
03/20/17 Is it time for "Conditional Approvals"?
I have been working on this plan for a while, but I think now is the time for it to actually be approved. Everything is coming together - like the perfect storm:
1. We finally have a few experimental treatments in the pipeline that look really good.
2. The new president is slashing regulations and calling for faster FDA approvals and for slashing drug prices.
3. Computer technology and biostatistics have reached the point where our plan for a registry trial can be just as reliable - maybe more so - than traditional phase 3 trials.
IF this plan is put into effect, I predict we would have an immediate breakthrough in the treatment of brain tumors, and the possibility of a cure in a few years, instead of the decades it would take on the current path.
I need the support of other organizations now, and in a few weeks I may need everyone to be writing letters and making phone calls. I will send out details when it is time!
03/10/17 Trump Chooses Dr. Scott Gottlieb To Head Food And Drug Administration
Sounds like a great pick! I have been working on a plan to speed up drug approvals for brain tumors - and slash the price of new drugs. Maybe Dr Gottlieb would be open to the idea of helping brain tumor patients. Does anyone happen to have a connection to him? Let me know!
03/10/17 Clinical Trial Announcement
Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Glioblastoma at First Recurrence or Progression
Disclosure: the company that makes this is a sponsor of the Musella Foundation
This is an exciting trial. It is similar (although it uses a different target) to a trial done a long time ago that failed because the state of the art in convection enhanced delivery at that time did not allow the drug to get to the entire tumor. Now the technology has improved to the point where it can deliver the drug to just about anywhere we want it to go! A major advantage of this type of treatment over other immunotherapies is that it does not rely on your immune system to help it. The fusion protein binds to the IL-4 receptor (which about 80% of glioblastomas over-express, and normal cells do not express), and carried the toxin to those cells - which makes this a smart bomb type of approach - it should theoretically kill tumor cells and not normal cells.
03/10/17 Role of MGMT Methylation Status at Time of Diagnosis and Recurrence for Patients with Glioblastoma: Clinical Implications.
Good project, but I disagree with their conclusion. They found that 25% of the time, the methylation status changes between the first and second surgery. They conclude that it is insignificant and we shouldn't bother testing the second time as it provides no useful information. They are correct for now, but that should change very shortly as there is now a drug in clinical trials that can work on unmethylated patients. This makes the methylation status very important to determine, and for those 25% of patients with the changed status, it can be a life altering test.
03/08/17 Phase 1b Study PVSRIPO for Recurrent Malignant Glioma in Children set to open soon
This is the polio vaccine treatment for brain tumors that was covered in 2 60 minutes episodes. Very exciting. And I am so proud to announce that the Musella Foundation played a role in getting this trial started for children aged 12-18. The clinicaltrials.gov listing names us as a "sponsor and collaborator"!
It should open soon.
02/26/17 Renowned Neuro-oncologist Joining Northwestern
One of my favorites neuro-oncs is coming to the USA. He twice changed the standard of care for GBMs. Hopefully he will have more resources at Northwestern to speed up the search for the cure. I welcome him and wish him luck!
02/23/17 Tocagen Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Toca 511 & Toca FC in Recurrent High Grade Glioma
This is very exciting news. I have always felt that it is almost criminal that most patients do not have access to treatments like this. They have shown that the treatment is safe, and early results show impressive results - at least a doubling of average survival with some patients still doing perfectly for a long time. This breakthrough therapy designation will speed up the process of approval. It opens the possibility that FDA approval could come based on the phase 2 trial which has completely enrollment and results should be available within a year, which means that FDA approval might be possible by the end of next year. Unfortunately not soon enough for anyone who has a brain tumor now. We still have to work on ways to make it available now to people who need it - possibly using compassionate use or the right to try laws.
02/22/17 UPDATED: Agenus’ lead cancer vaccine flops, investigators read last rites over glioblastoma PhII
Unfortunately, this trial failed. It may have failed because the vaccine was started too late - at the time of recurrence. It makes a lot more sense to try it for newly diagnosed healthier patients. Adding in a checkpoint inhibitor should also help. Lastly, with other vaccines, the early readings of the trial did not look good, but as time goes on, there was a small group of patients who do well for a much longer time than expected.
Displaying Stories 1 to 20 of 6128