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Note: The comments under each article title are the opinion of our president, Al Musella, DPM, and do not reflect official policy of the Musella Foundation!

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06/29/20 First annual Dragon Derby!        

 From our good friends at the Dragon Masters Foundation - they will use the funds for brain tumor research!   You can buy a dragon and watch the race live on Facebook. Should be fun!




06/29/20 A phase I/II study of veliparib (ABT-888) with radiation and temozolomide in newly diagnosed diffuse pontine glioma: a Pediatric Brain Tumor Consortium study        

 Unfortunately, this trial was not a success.  I was hoping it would work - this drug did well with ovarian cancer. It is not over yet - it may be worth testing with other combinations. 




06/28/20 David Zagzag, MD, Ph.D. Recognized as a Professional of the Year for 2020 by Strathmore's Who's Who Worldwide        

 Congratulations to Dr Zagzag - he deserves it!    We gave him a research grant a long time ago and he became one of my friends! He is one fo the best neuro-pathologists in the world, 




06/27/20 ERC Belgium Submits Marketing Authorization Application to European Medicines Agency (EMA) for Glioblastoma Immunotherapy, SITOIGANAP        

 

 This is great news for Europe. This vaccine was shown to be very safe, and early results show that it helps some patients, with more than 10 % of recurrent GBM patients survived over 3 years which is pretty good.  They are applying for a conditional approval in Europe. Here in the USA we do not have conditional approvals yet and it will take another few years to make this available in the USA.  I am working on a bill that would allow the conditional pathway to be used here in the USA. I will write a news blast about it in a few days!

 




06/25/20 A Systematic Review of Tumor Treating Fields Therapy for High-Grade Gliomas        
I did not see the full text of this (they wanted to charge $39.95 to see the full article and it doesn't look like it is worth it) so my comments apply to the abstract which is freely available on the internet.
 
From the wording of the abstract, it is unbelievable that a journal like Neuro-oncology would publish this biased nonsense or that it got through the peer review process.
 
There are some doctors that are skeptical about this therapy which is FDA approved.  That is true. There are about 800 hospitals in the USA that  do use it so it is not the majority who are skeptical. That is a subjective feeling about the treatment and it might be ok to say it in the introduction - but does not belong in the conclusion if it is not supported by the research cited. 
 
In the results, they say there were 852 studies, but only included 9 of them, with 1191 patients.  They also say that it improved survival in newly diagnosed glioblastoma (and not in recurrent).
 
  The conclusion should be based on the methods and results which are hard data - not to include subjective pre-conceived notions about "concerns" that some doctors may have.  They never said they surveyed doctors to see how they feel about Optune. 
 
  There has never been a phase 3 trial in adult glioblastoma that had better results than the Optune trial for newly diagnosed.  The concerns about the trial design were dispelled at the Medicare hearings.  (Mostly the question is why not use a sham device in the control group. The answer is it was impractical and unethical as the sham device would require patients to shave their heads and apply a fake device for 2 years without any chance of benefit, and besides, the final endpoint was overall survival which can not be affected by the bias of the doctors knowing who gets the treatment or not).  
 
  The conclusion mentions "concerns" about the  quality of life,  which was addressed in many of the studies.  Who has the concerns?  The majority of patients would prefer a skin rash and annoyance of using the device to using a wheelchair or coffin. Or of using any other treatment that has worse side effects and has not been shown to help as much as Optune. Patients should be given the choice. It is ok if they do not want it but for an author to project their own biases onto patients without research is not typical of a peer reviewed article.
 
It then goes on about concerns over the cost of therapy.  The cost of everything is sky high today (we are working on that with the Promising Pathway Act).   Optune cost about half of the price of Avastin (per month), which has never been questioned. The phase 3 trials reported the largest ever improvement in survival for newly diagnosed patients on Optune compared to NO increase in survival for Avastin.   I know of no patient who wanted Optune that was not able to get it due to the cost. Almost every insurance plan covers it and there are programs to help pay.  
 
And finally they suggest further investigation is needed. There were 852 studies so far. What chance is there that another study is going to sway the handful of doctors who are biased against this treatment? 
 
 I do agree we need more research to find combinations that make it work better, but the way they said it, we need more research to provie it works which has already been proven!
 
Disclosure: The companies that make Optune and Avastin are sponsors of our organization. (And I am a fan of both Optune and Avastin).
 



06/24/20 DelMar Pharmaceuticals Presents Positive Interim Data on VAL-083 Demonstrating Favorable Outcomes in Both Newly- Diagnosed and Recurrent GBM at the AACR Virtual Annual Meeting II        

 This is sort of mixed results contrary to how the headline reads.  In newly diagnosed MGMT unmethylated glioblastoma (this is the worst category of glioblastoma) , they reported about a 2 month improvement in progression free survival compared to historical data on temozolomide, which is good but for recurrent MGMT unmetylated glioblastoma, the did about the same as historical controls. 

Bottom line - more research needs to be done to find ways to make it work better. It obviously has some effect but they need to work on how best to use it, why it doesn't work as well as we hoped and how to fix that. I think it will have a place in the ultimate cocktail, replacing temozolomide for MGMT unmethylated patients. Remember - temozolomide was rejected by the FDA the first time the FDA was asked to approve it because early testing did not show an improvement, but then later studies showed the major benefit that makes temozolomide the standard of care.

 




06/24/20 Musella Foundation Copay Program now closed to new patients        

While we are closed, try goodrx.com to get discount coupons - it may help.

 




06/24/20 New class of precision medicine strips cancer of its DNA defenses        

 This is too early to tell if it would help brain tumor patients but it is a new approach - a new class of drug that might help ALL types of cancer!  Will keep an eye on it!




06/22/20 Exploiting Cancer’s Tactics to Make Cancer a Manageable Chronic Disease        

 

 This excellent article explains why Glioblastomas are so hard to treat - it reviews past history of treatments and suggest a new concept to fight glioblastomas. We (the Musella Foundation) gave the author a grant to study the treatment she talks about!  It may eventually result in a breakthrough - although it is at the pre-clinical stage now.

 




06/21/20 Brain Tumor Webinars continue tonight! Sunday 6/21/2020 7pm Eastern Time        

 Another great speaker tonight!  Dr Kesari is an old friend - he is involved in a lot of cutting edge research including the CAR-T cell trial.  

We do not have any more webinars scheduled. If you have any ideas for topics and / or speakers, let me know!




06/18/20 Gallagher, Colleagues Introduce Bipartisan Promising Pathways Act        

 This is one of the most important (if not - THE most important) bill for brain tumor patients ever!  It will drastically speed up the search for the cure, increase your treatment options, increase the amount of research being done, and hopefully decrease the cost of treatments!

    We will soon ask for your help in supporting this bill. Do not do anything yet - we are trying to figure out how best to help. If anyone has experience in this area, contact me!   

Al Musella, DPM
Musella Foundation
888-295-4740
Musella@virtualtrials.com

 

 




06/15/20 Karyopharm Announces Dosing of First Patient in a Phase 1/2 Study of Selinexor in Combination with Standard of Care Therapy for Patients with Newly Diagnosed or Recurrent Glioblastoma        

 This drug is approved for other cancers so it may be available off label, so if the trial reports success, we can use it right away!




06/15/20 The Musella Foundation Awards 2 Brain Tumor Research Grants        

  What a horrible start to the fundraising year!  Last year at this time we gave out 9 grants for $495,000.  This year only gave out 2 grants for $59,432 with another $25-50k possibly going to be awarded soon.

However, these are good projects. unfortunately we had to reject a few other good projects. Hopefully things will get back to normal later this year.




06/15/20 Global Post-Marketing Safety Surveillance of Tumor Treating Fields (TTFields) in Patients With High-Grade Glioma in Clinical Practice        

Now that patients are living longer, safety becomes very important.  At the time Optune was invented, the number of long term survivors was negligible, so we did not worry about long term safety.  Now that there is a chance at becoming a long term survivor, safety matters a lot!  This was a study of over 11,000 patients who used Optune and they found no serious side effects other than skin irritations which were manageable.




06/15/20 Cancer Vaccine Plus Adoptive T-cell Therapy Placed on Fast Track        

 Great news!  This brings the vaccine closer to approval. Early reports showed over a 6 month improvement in survival, which is significant and 23% of patients had tumor reductions.  Fast track designation and orphan designation mean the FDA has looked at the data and shows an interest in speeding it up.  




06/13/20 Brain Tumor Webinar Series continues tonight! 6/14/2020        

 All of the webinars this year have been great - informative, fun and lots of good questions were asked.  All had over 1,000 views!  Although the topic is pediatric brain tumors tonight, it will also talk about Diffuse Midline Glioma, which is relatively common in young adults as well as children.




06/13/20 Global Coalition for Adaptive Research (GCAR) Selects DelMar Pharmaceuticals' VAL-083 to Participate in the GBM AGILE Pivotal Study, an Adaptive Clinical Trial Platform in Glioblastoma Multiforme        

 GBM Agile is the next generation of clinical trial - where multiple drugs are tested against a common control arm, instead of each trial having it's own control arm.  They selected Val-083 to test in one of the arms of the trial. Val-083 is an experimental chemotherapy, similar to Temodar but it works on a different area of the DNA so the MGMT repair enzyme can not undo the damage it does to the tumor. In theory, it should not matter if the MGMT is methylated or unmethylated.  With Temodar, if your MGMT is unmethylated, there is a much less chance that it will help.  This is probably the best and fastest path to FDA approval for Val-083. I wish them luck.




06/07/20 Brain Tumor Webinars continue tonight!        

 

 Tonight's webinar is another great one. Dr Duma is working on a few treatments that may have a huge impact.

We also added another webinar next week - about DIPG / Diffuse midline glioma

 

 




06/05/20 The McDowell Family Lost A Child To Cancer And Now They Are Creating a Tourist Attraction to Fund Research– So Why Are Some Of The Neighbors So Angry?        

 Such a sad story.  This is a friend of mine.  His son died of a medulloblastoma and it was devastating. He got into fundraising for pediatric brain tumor research, and has made some large donations to the Musella Foundation and other research organizations.  He had a vison for a huge fundraiser that will make a huge difference. He was going to create a tourist attraction where the profits go to pediatric brain tumor research.  He bought the land, and drew up the plans but then ran into an "environmental" group who did not want it to happen.  So they protest and sued him and shut down the project for now. 

With all of the things going wrong with the world right now, these people pick saving the lives of kids with cancer to protest. Unbeleivable.

We have so many projects that could get done with the funding.  We are running a major pediatric research project that may have to close down in about 2 weeks as we do not have the funding. I know of a few promising treatments that are just waiting for funding.  




06/02/20 First Patient Treated in Phase 1 Clinical Trial Of Incysus Therapeutics Gamma Delta (?d) T Cell Immunotherapy for Patients With Newly Diagnosed Glioblastoma        

 This is obviously too early to tell how it works but it is an exciting new concept and I wish them luck.




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