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Brain Tumor News!


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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12/05/22 Our webinar with Dr Linda Liau on DcVax is tonight 12/5/22 at 8:30pm Eastern        

Tonight’s' webinar should be great!  Dr Liau published the results of the DcVax trial recently.  Read that article before watching the webinar.  There has been some misinformation spreading about the trial. Hopefully tonight's webinar will clarify everything and show that this trial was a complete success.  It is the story of the year and a breakthrough brain tumor treatment!



12/05/22 CLINICAL EFFICACY AND PREDICTIVE BIOMARKERS OF ONC201 IN H3K27M-MUTANT DIFFUSE MIDLINE GLIOMA        

 This is the results of 2 trials of the drug Onc-201 for DIPG and DMG.   Bottom line is this oral drug with minimal side effects doubles survival. This is in a tumor type that really has no effective treatments.  This should be made available now on an emergency basis. This is why we need the Promising Pathway Act. If this bill was passed, we would have had approval of Onc-201 years ago. The current system is outdated.



12/02/22 Musella Foundation Brain Tumor Copay Program now open for new and renewal applications!        

  The program will be open probably for a few days but we never know how many applications come in.  Might close sooner.   We have enough money (thanks to those who donated!)  for about 15 grants (of $5,000 each).  Do not be shy about applying - if this can releive some of your stress - it is worth applying!



12/01/22 Cohen Milstein Files Lawsuit on Behalf of Northwest Biotherapeutics Against Major Market Makers for Market Manipulation        

 People always ask me why Northwest Biotherapeutics' stock didn't skyrocket when they released fantastic news that their phase 3 clinical trial was a complete success.  It made people think there was something wrong,  and unless you read the full publication along with the supplemental materials which clearly answers all of the negative comments floating around about the trial, you might be tempted to believe some of the misleading articles that were published about the trial.     This article talks about the main reason why the stock is so low and has gone lower every time the company announced good news.  It is probably  (innocent until proven guilty) because of stock manipulation by a few greedy companies who care more about money than your lives.    This scam has delayed the approval of DCVAX by years - killing many people who might have been saved.   Hopefully this ends now, and we can get back to finding the cure!



12/01/22 Convection-enhanced delivery of Topotecan active in glioblastoma        

 This article talks about a new way to get drugs into the brain.  CED is convection enhanced delivery, and it has been used for a long time as a one shot deal.  Now this system can be used over time, in this case 4 treatments once a week for 4 weeks.  Topotecan is a drug that works great against brain tumors in the test tube, but doesn't cross the blood brain barrier so it doesn't work when given IV.  These researchers tried it with this new form of extended CED and early results look promising. All 5 patients had significant reduction in tumor size. That is great news because the FDA has said it would approve treatments quickly if they had a high response rate.  Topotecan is already approved, and this CED system is not a permanent implant - it is easily removed.  Once it is approved we can try all sorts of drug cocktails personalized to the biopsy.



11/29/22 Novocure's Optune® Approved in Canada for the Treatment of Newly Diagnosed and Recurrent Glioblastoma        

 It took way too long but Optune is now approved in Canada!



11/28/22 Virtual Trials: Causally-validated treatment effects efficiently learned from an observational cancer registry        

 I (along with my team:) published an article in the journal: "Artificial Intelligence in Medicine".  It is about our brain tumor virtual trial. We compared our data to the data from 7 randomized trials around the same time and found that we could have predicted the outcomes in 6 of the trials by using our data. For the 7th trial that was close but not perfect, we went back to look why we missed - we had different patient populations - they had recurrent GBM patients who never had chemotherapy before which is really strange. All of our patients failed Temodar up front, so when we looked at recurrent patients, we got a different readout.   Bottom line, what we did for basically free probably could have replaced trials costing millions of dollars.

  That was our old version of the registry (started in 1993).. biomarkers were missing.  Our new current version (run by our partners at xCures) has complete patient data so should be much better. I would say could possibly be better than a randomized trial if we match for all known prognostic indicators!  


11/24/22 Ulixertinib may change childhood brain tumor treatment        

 xCures is running an expanded access program of this drug for any type of cancer that has  MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.    Low grade gliomas have a high chance of having this mutation. Glioblastomas, Pancreatic Cancer, Colon cancer, Ovarian and more types of cancers also sometimes get this mutation. Check your pathology report for it.

 


11/22/22 Musella Foundation 2022 Highlights        

 At this time of year we like to reflect back on the year so far and share the highlights with you!  I also need to ask for donations.   The highlights letter linked below is part of a package we send out once a year by mail  to all of the people who have donated to us in the past - where we also ask for more donations!

I hate to ask our members for donations - I understand most families dealing with brain tumors have enough problems, but if you are in a position where you can make a donation - please do!  Ask your friends to donate in your honor!  If you can't - do not worry about it - I understand.

Have a Happy Thanksgiving!



11/22/22 The accelerated approval pathway is evolving in plain sight, with or without congressional help        

 This is completely unacceptable to the brain tumor community. The FDA is taking it upon itself to use it's regulatory flexibility to change the way accelerated approval works. The article hints that this will add more than 3 1/2 years to the process of getting approval.   The cause of this change seems to be a mistake they made with approving a drug for Alzheimer’s disease.   There are a few drugs that should have already received accelerated approval for brain tumors and I am being told the FDA told these companies they couldn't even apply yet, and that they want a final phase 3 placebo controlled trial fully enrolled before the FDA would accept an application for accelerated approval. This will kill thousands of patients needlessly and reduce the number of treatments available to us.  This is the same FDA that told me they do not have the regulatory flexibility to grant accelerated approval to a treatment that has been shown to work well in phase 3 trial, but only in certain subgroups that made sense.  They wanted a repeat of the phase 3 randomized trial in those  subgroups, which makes perfect sense from a scientific viewpoint but wound up making the company go out of business, forcing us to lose the treatment forever, and probably killing 1,000- 2,000 brain tumor patients a year needlessly.   

I am working on a fix. I invite other foundations who are also interested in this to contact me.  My original plan was the promising pathway act, which would create a new conditional approval pathway to allow treatments to get approved after a phase 2 trial, but require all patients who use the drugs approved under this pathway to participate in a virtual trial until efficacy was proven, or failure was shown.   That bill is still in Congress - so it has a chance - but I have thought of another possible way forward. Change accelerated approval to require all patients who use drugs approved by the pathway to participate in a virtual trial, instead of requiring the confirmatory trial. This would go on until we either proved the drug works or not.  This would give us more knowledge as we learn from every patient.  



11/22/22 The children's brain tumor network (CBTN) - Accelerating research in pediatric central nervous system tumors through collaboration and open science        

 The Children's Brain Tumor Network (CBTN) is a multi-institutional international clinical research consortium created to advance therapeutic development through the collection and rapid distribution of biospecimens and data via open-science research platforms for real-time access and use by the global research community.  We are proud to be a foundational partner!



11/22/22 PHASE II TRIAL OF SURVAXM PLUS TEMOZOLOMIDE FOR NEWLY DIAGNOSED GLIOBLASTOMA        

Impressive results for newly diagnosed GBM with a "stock" vaccine - this is not custom made for each patient but instead targets Survivin, which is overexpressed in over 95% of GBM patients.  This is now in clinical trials for newly diagnosed GBM as well as children with progressive or relapsed brain tumors including GBM, AA, medulloblastoma,  Ependymoma and others. For DIPG, the trial accepts non relapsed DIPG (After radiation).  



11/21/22 DCVAX webinar: Monday Dec 5, 2022 at 8:30 PM Eastern        

 This is a must see by anyone involved with brain tumors. DCVAX is an experimental vaccine therapy. The results of the phase 3 trial were published recently Excellent results in newly diagnosed as well as recurrent GBM. Dr Liau is the co-inventor of the vaccine and ran the clinical trial.  As always, our webinars are free, however donations are appreciated. If you make a donation (by clicking the DONATE button on the webinar page), mention in the comment you want the donation to be used for vaccines only and we will use 100% of your donation to help speed up the approval of vaccine therapies.



11/19/22 - Real world clinical outcomes of patients with diffuse midline glioma in a longitudinal outcomes registry        

This is the results of our Onc-201 expanded access program for DIPG and DMG.  I am one of the authors! The results are outstanding. We compared patients in our registry with DIPG and DMG who took Onc-201 compared to those that did not take Onc-201 but instead did other treatments including clinical trials.  There was a significant increase in median survival, but more importantly there is a long tail of about 25% of the patients went on to do well, whereas those without Onc201 all died.  And this is only the start.  Once it gets FDA approved, we will be experimenting to find the best combinations and hopefully move that tail up to 100%!  There were a lot of interesting reports of treatments at SNO this week that might be amenable to combining with Onc-201, but the key is getting the approval from the FDA so we can try these combinations!   

The poster also shows that immune checkpoint inhibitors do well if used as part of the treatment plan. Trial after trial of them alone showed no benefit, but in our registry we looked at patients who used immune checkpoint inhibitors vs. those that did not, and those who used them had a much higher tail!  We just need to learn how best to use them, and our (Musella Foundation, Cancer Commons and xCures) registry  / patient navigation program is going to be the fastest way to figure it out!



11/19/22 Northwest Biotherapeutics Reports Positive Top-Line Results From Phase 3 Trial of DCVax®-L for Glioblastoma        

 I am very excited about this treatment.   This is the first trial to ever report extended survival in both newly diagnosed and recurrent Glioblastoma.  For newly diagnosed Glioblastoma, 5 year survival more than doubled  from 5.7% to 13%.  And for recurrent Glioblastoma, survival at 20 months and 30 months also doubled, from 9.6% to 15.7% at 24 months and from 5.1% to 11.1% at 30 months.  This is all with a few simple injections which had no side effects. 



11/19/22 Plus Therapeutics Provides Updates on ReSPECT™ Clinical Trials at the 27th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology        

 Early results but look pretty good. We did a webinar about this trial recently, it is worth watching. This is a new way to deliver radiation directly to where it is needed.



11/19/22 POSITIVE UPDATED INTERIM RESULTS FROM NOX-A12 GLORIA PHASE 1/2 IN BRAIN CANCER PRESENTED AT THE SOCIETY FOR NEURO-ONCOLOGY 2022 ANNUAL MEETING        

 This is a new approach that targets the tumor microenvironment.  See their website for details!  This trial is early, but has very impressive results in a bad patient population - those who have MGMT unmethylated.  90% of patients had tumors shrink, and 40% had a partial response. The median survival has not been reached yet as the patients are still alive after average follow up of 7.9 months.  There is a link to the poster presentation as well as a webinar they will be having about it soon, in the press release linked below!



11/17/22 Vaccine shown to prolong life of patients with aggressive brain cancer        

 This article talks about the results of the DCVAX trial in plain english!  



11/17/22 Novocure Announces 25 Abstracts on Tumor Treating Fields Therapy at Society for Neuro-Oncology 2022 Annual Meeting        

 Optune is the most effective treatment approved for Glioblastoma. By far.  Yet it is still underused, mostly due (I think) to patients making the decision at a time when it has not yet sunk in how bad this disease is.They do not want to shave their heads and wear a device constantly. When they finaly realize, it is too late.  Another reason is lack of familiarity of the doctors with tumor treating fields.  It is a new concept to them, and the older doctors remember a fake electric device that was popular in the 1900s which did not work and they associated Optune with that.

There is a tremendous amount of research on tumor treating fields.  There are 25 research projects on Optune being presented at the SNO meeting which is going on now.  All of them reinforce the importance of Optune in the treatment plan for Glioblastoma and show how to make it even more effective.  One of the keys is using Optune the right way - which is with at least 90% or more complaince. It only works while it is on, so you give the tumor a chance to recover when you turn it off too long.

I think the ultimate cocktail that has a chance to be a cure is going to involve Optune, a vaccine, a checkpoint inhibitor and one or two other therapies.  There are many other treatments being presented at SNO this week that might be able to fill in the gaps and make it so most Glioblastoma patients become long term survivors, and not only survivors - but survivors in great shape. This is within reach now for the rich and hopefully for everyone next year..  We are trying to speed that up!



11/17/22 Association of Autologous Tumor Lysate Loaded Dendritic Cell Vaccination With Extended Survival Among Patients With Newly Diagnosed and Recurrent Glioblastoma        

 This is the peer reviewed publication of the DCVAX trial that we have been waiting for!   Same excellent results that we reported in May but they go into details such as how the external control arm was constructed to account for all of the variables including the fact that the DCVAX trial rejected patients who progressed quickly during radiation.  I feel the article responds very well  to every critisism I heard from the May report..  And it was published in a high impact Journal - JAMA Oncology which has an impact factor of 33, where anything over a 10 is considered "excellent"!



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