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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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07/11/20 Comparative Epidemiology of Gliosarcoma and Glioblastoma and the Impact of Race on Overall Survival: A Systematic Literature Review        
This is similiar to an article I posted a few weeks ago, both show that there is a large discrepancy in both clinical trial participation as well as overall survival by race.    This is not acceptable. We are working on leveling the playing field by collaborating with the Society of Neuro-oncology as well as a group of research and other organizations to remove barriers to participation in clinical trials. 
 
Our copayment assistance program was a major help in this regard - as a major part of the survival difference is inability to afford treatments - however we ran out of money and our program is closed to new patients. We get calls every day asking for help and right now there are no copay programs open to help people on Temodar.  Many patients are sadly going without it.
 



07/09/20 Ziopharm Oncology Doses First DIPG Patient in Phase 1/2 Trial of Controlled IL-12 for the Treatment of Pediatric Brain Tumors        

 This is a fascinating gene therapy that can be controlled by an oral drug - the gene therapy is injected into the tumor and it inserts a gene that when activated by the oral drug produces IL-12, which is an immune enhancer.  The problem is too much IL-12 causes severe problems so there is a need to be able to control it. They use this oral drug to control it and can turn off the gene therapy if needed simply by stopping the oral drug. 

They announced the first use of it in a DIPG patient.  They used it on over 175 other patients with other cancers, mostly glioblastoma, with relatively good results.   I wish them luck!

 




07/08/20 Musella Foundation awards another brain tumor research grants!        

 This grant will be combined with grants from many other charities, and it will allow the onc201 program to reopen soon for a few months. After that we will try to fund it on a month to month basis as long as needed (until FDA approval).




07/07/20 Survival, Costs, and Health Care Resource Use by Line of Therapy in US Medicare Patients With Newly Diagnosed Glioblastoma: A Retrospective Observational Study        

 This is pretty shocking. They looked only at Medicare patients, aged 66 or older with glioblastoma..  and this study covered the years 2007 - 2013 so it doesn't reflect the benefit (and costs) of recent treatments like Optune (as Medicare only approved payments for Optune last year) and GammaTile.

They found that the average survival for GBM was ony 5.9 months for those who had surgery and only 3 months for those that did not have surgery.  The numbers we usually see include young people who do much better.

This underscores the need for us to change the entire system. We have the opportunity to make a major change now but I need your help contacting your legislators (not even asking for donations!) . See virtualtrials.com/activism.cfm     This will make a huge difference and give us 5-10 new treatment options within months after the bill passes. I could see it easily doubling average survival - just by you taking 5 minutes of your time.




07/03/20 Everolimus improves the efficacy of dasatinib in PDGFRa-driven glioma        

 Look at your pathology report to see if you have the PDGFRα mutation...  if so it might be worth considering this combination!  It is early work but they did the research the right way - they came up with a theory, tested it in the lab and in animals, then tried it on a small group of people and it did pretty well.   The Musella Foundation helped support this project through our collaboration with the DIPG Collaborative.




07/03/20 Valganciclovir as Add-on to Standard Therapy in Glioblastoma Patients        

 Impressive gains for a relatively easy treatment. Valganciclovir (Valcyte) is approved for the treatment of cytomegalovirus so it is easily obtainable off label.  Small study and needs to be confirmed but might be worth considering!




07/03/20 Is polio the answer to curing brain tumors?        

 This experimental treatment is available in clinical trials at Duke (North Carolina), UCSF (California) and the University Hospitals (Ohio).




07/01/20 Early Imaging Marker of Progressing Glioblastoma: A Window of Opportunity        

 Interesting concept:  use advanced imaging to find progression faster than the current methods - perhaps early treatment would improve results?  




06/30/20 Musella Foundation awards two more brain tumor research grants!        

Wanted to say a big thank you to Wizathon.com, as well as our many volunteers and participants in the National Walk To End Brain Tumors.  Wizathon helped us turn our live 5k events into virtual events.  They did not do as well as in years past, but did much better than I expected considering the circumstances!

Hopefully things will get back to normal next year!




06/29/20 We need your supprt for the Promising Pathway Act        

I feel that this is the most important bill we have ever came across for brain tumor patients. 

 We need tens of thousands of people to do this to have a chance of a quick passage of this bill. Please pass it along on social media - facebook, twitter and even TikTok!

Contact me if you have questions about this bill!  musella@virtualtrials.com

 




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!




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