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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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"!



11/16/22 xCures presents clinical and translational research with two posters at the 2022 SNO Annual Meeting        

 One of these posters will present the results of our expanded access program for Onc-201 in DMG/DIPG.    I am an author.  If you are at SNO this week, look for the poster:

BIOS 03 Real world clinical outcomes of patients with diffuse midline glioma in a longitudinal outcomes registry.  If not going to SNO, I will post the poster in the next news blast as it is embargoed until Friday!

The other poster is EPCO 10: Systems biology based therapeutic predictions with gbmSYGNAL and clinical correlates in the real world longitudinal outcomes registry XCELSIOR which is about our registry and some of the neat things you can do by just analyzing the data it contains!

 
You are going to be hearing a lot about xCures as they are at the forefront of the effort to speed up the search for the cure.  I was a co-founder of xCures and am a paid consultant to it. They (along with our other partner,  Cancer Commons) help run our patient navigation program and the registry. They also ran our expanded access program that will be described in the poster.   I started the first online brain tumor registry back in 1993 and it was impossible to get regulatory grade data. All data entry was manual, and usually missing important documents or events. We couldn't scale it as it was so labor intensive.  It took weeks to get complete records when we were able to do so. We now outsource all of that work  to xCures, and in most cases they can get complete medical records within 15-30 minutes and crunch them into a structured format and give a beautiful patient summary report of all of the highlights, They can then search their database of treatment options and the registry and find the best options for patients.  Most of this is automated so it can scale to unlimited patients.  We started with brain cancer but expanded to all cancers with an emphasis on pancreatic, lung, colon and breast cancers.
To learn more about xCures, watch this short video or visit the xCures.com website!


11/16/22 CTIM-27. AUTOLOGOUS TUMOR LYSATE-LOADED DENDRITIC CELL VACCINATION IMPROVES SURVIVAL IN PATIENTS WITH NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA: SURVIVAL RESULTS FROM A PHASE 3 TRIAL        

 This is the abstract for Dr. Linda Liau's presentation of the DCVAX trial results at the SNO meeting this weekend!  The trial was a major success for both newly diagnosed and recurrent glioblastoma! I will have more details after she presents it!



11/14/22 Giving Tuesday Contest        

I hate asking our members for donation - I understand most families dealing with a brain tumor have enough financial stress that I don't have to add to it.  However, this is a simple and free way to help us raise a few thousand dollars!  Just vote for the Musella Foundation on Facebook, Instagram and Twitter in this contest!

 Of course, if you aren't having financial stress - donations are appreciated!  We are held back from doing even more by lack of money.  

And don't forget to use smile.amazon.com when you buy from Amazon this holiday season.   We get a small % of your purchase amount and it doesn't cost anything!  Just select "Musella Foundation" as your charity.  We also participate with Walmart's Round Up program. When you buy something at Walmart.com, it will ask if you want to Round Up for charity.  It will cost you less than a dollar, but they add up quickly since so many people buy from Walmart.com.  Just make sure to select "Musella Foundation".

Having said that - we do send out one mailing a year to all of our donors, telling you about our accomplishments for the year and asking for another donation.  Of course - if you are stressed,  ignore it! We serve everyone the same regardless of if they donate or not.   I will send the list of accomplishments out next week. We have a huge one coming up this Friday!



11/14/22 Musella Foundation collaborates with the DIPG/DMG Collaborative to give out $198,436 grant for a low side effect innovative clinical trial for DIPG/DMG        

 The Musella Foundation has been a foundational partner of the DIPG/ DMG Collaborative for the last 6 years and we have helped them fund over $15 million dollars of research grants. All of them are special and important but this one is extra special to me.  Dr. Marcus has been working on Sonodynamic therapy for 20 years and has been able to cure mice with it.  He finally got to try it - with success - on adults with Glioblastoma recently and tried it on one child with a DIPG. He came to the Collaborative to ask for funding to launch a clinical trial in kids with DIPG and DMG.  In this video, he doesn't know that his request was approved - we spring it on him!  This is just 8 minutes long - worth watching!



11/14/22 Starving Cancer Cells Without Starving You        

The guest speaker on this episode of xCures' "Target Cancer Podcast" series is Dr. Siddhartha Mukherjee.  He is a Pulitzer prize winning author (and my favorite author), researcher and Harvard trained cancer physician at Columbia Univerisity Medical Center in NY.  He has interesting new ideas about how diet (precision nutrition) can be used to help treat cancer.   Forget trying to reduce sugar. His approach is to figure out which essential ammino acids the tumor needs more than the normal cells, and then provide a diet that minimizes those amino acids.He co-founded Faeth Therapeutics to test his ideas. He is using xCures to help run a clinical trial of precision nutrition for the treatment of metastatic pancreatic cancer.    

This is not directly related to brain tumors but if it works, we can apply the same concept to all cancers.

Disclaimer: I am a co-founder of xCures and am a paid consultant.



11/14/22 First Patient Enrolled in Phase 1 Study of MTX-110 (MAGIC-G1 Study) in Patients with Recurrent Glioblastoma        

 MTX110 is a reformulation of Panobinostat, which is an oral medication approved to treat multiple myeloma.  In the test tube, it worked great against brain tumors (actually tested as the most promising anticancer agent of all 84 drugs tested) but unfortunately it doesn't cross the blood brain barrier well.   Midatech Pharma reformulated it so that it could be injected directly into the tumor using CED (Convection Enhanced Delivery). There are ongoing trials using it for DIPG and Meduloblastoma.  This is the first time it is being used for recurrent Glioblastoma. 



11/13/22 Souped-up oncolytic virus warms up cold brain cancer tumors        

 Sounds like a great idea.  Will be watching it.



11/12/22 Candel Therapeutics Announces Late-Breaking Oral Presentation at SITC Annual Meeting        

 This is the results of a new treatment for brain tumors.  Early results look promising!



11/11/22 Novocure Secures CE Mark for New Array        

 The new arrays will be more comfortable and should work better than the current arrays. These arrays will soon be available in Europe and they are working on getting it approved by the FDA in the USA.  Will let you know when they are available here!



11/11/22 Concurrent chemoradiation and Tumor Treating Fields (TTFields, 200 kHz) for patients with newly diagnosed glioblastoma: patterns of progression in a single institution pilot study        

 First - the abstract states that Tumor Treating Fields (Optune) is now the standard of care for Glioblastoma.  

Next - they present the results of a clinical trial of starting Optune earlier - at the same time as the start of radiation instead of the usual 4-6 weeks after radiation ends.  They found the progression free survival to be 9.3 months, which means that this adds about 2.5 months to the progression free survival of using Optune the standard way, and is adds 5 months to the expected progression free survival from Temozolomide without Optune. It is such a simple change and buys more time for other things to work, it is worth trying it. 



11/11/22 Alpheus Medical Treats First Patients in First-In-Human Clinical Trial for Novel High-Grade Glioma Brain Cancer Treatment        

There are a few Focused Ultrasound trials, all trying different but related ways of treating brain tumors. The difference between this trial and the others is that this trial treats the tumor and a large area around it, but most of the others treat just the tumor area.  The idea being that there are tumor cells outside of the main tumor mass that will just grow back if not addressed.   We will see which way is better and safer when the trials are over, but for now, I like any of them.  I think focused ultrasound is going to play a major part in the ultimate cocktail approach.



11/09/22 Navigating Emotional Wellbeing as a GBM Caregiver: A Conversations with Mental Health Experts        

 This is from our good friends at Roon.care   This is a new community for Glioblastoma patients and caregivers.  It is worth taking a look at roon.care  it is free to join. They are having a webinar on caregiving tomorrow.



11/09/22 Starting with ADC, FDA calls for fully enrolled confirmatory trial prior to accelerated approval submission        

 This article is not  about brain tumors directly but it says the FDA now wants to change the rules for accelerated approval. In the past, they required a confirmatory trial after accelerated approval was granted. Most drug companies obviously wanted to slow down the process because if the results were bad, they lose the approval. If it is good, they gain nothing. Duh.   Many of the trials never complete because why would you enter a randomized trial for a drug and have a chance at getting a placebo (or standard of care) OR the drug when you can just get the drug directly. The entire system is insane.  Anyway - the FDA is now telling this drug company (and it infers this will be the rules going forward) that the confirmatory trial not only has to start, but the FDA wants the trial to be fully enrolled before they can get acceslerated approval.    This will cut maybe a year off of the regular process of FDA approval, but would also add a few years and tens of millions of dollars to the accelerated approval process. Not only is it wasting time and lives, but the additional wait time and costs will drive the prices of the drug way higher.

An alternative is my promising pathway act.  If that is too radical for the FDA, then just adopt the most important part - the registry. Require all patients who take an accelerated approval drug to be followed in a registry. It may add $1,000 a year to the cost of the drug, which is way less than the added cost under the proposed plan.  By observing all patients who use the drug we quickly will learn how to use it best and if it is worthy of full approval.



11/08/22 Step taken towards non-surgical treatment for schwannomas        

  This is very early work, but it is an exciting idea - to treat Schwannomas (and maybe meningiomas) with a 2 drug cocktail instead of surgery or radiation.  These tumors used to be deadly but today can be cured most of the time. Unfortunately the cure sometimes has side effects - the surgery is long and has a long recovery, there is a chance at deafness, tinnitus, dizzyness and/ or loss of facial nerve function.  There has been very little work on drugs to treat this because the cure rate was so high, but now these researchers are trying! Will keep an eye on this.



11/07/22 Reminder: Webinar tonight (11/7/22 at 7pm Eastern) on Sonodynamic Therapy for Brain Tumors        

 This one is a must to watch. I think Sonodynamic therapy is going to be a breakthrough in the treatment of brain tumors. It is a noninvasive, relatively easy and painless procedure, kills only tumor cells and can be repeated if needed. This is still considered experimental and is in clinical trials now.



11/04/22 OKN-007 Expanded Access for Pediatric Patients with Diffuse Midline Glioma(including DIPG)        

 The Musella Foundation gave a brain tumor research grant back in 2013 to Dr Towner to investigate this new treatment, OKN-007.  A phase 1 trial was done in recurrent glioblastoma, where it was found to be safe to the point where they couldn't find a toxic dose!  Early results in the highest dosage group showed an average survival of 21 months. There were no controls since this was a phase 1 trial, but we know from experience that the average survival for recurrent Glioblastoma is around 8 months.   Clinical trials of OKN-007 are now ongoing for newly diagnosed and recurrent high grade glioma.    Mouse studies were done on DIPG models which resulted in a huge decrease in tumor volume, so we wanted  DIPG and DMG patients to get access. We helped get this expanded access program started, in a way that is really a virtual trial, in that xCures will be observing the outcomes and hopefully the real world data collected can help speed up the FDA Approval provess.   I think it is worth a try. 



11/04/22 Finally, cancer patients have real-time access to their medical records        

 This is big!   For the first time, we are able to collect and distill a patient's medical records quickly and automatically.   This program is the heart of our patient navigation program. The hardest part used to be getting the patient medical records into our database, and creating the patient journey so we could figure out the best treatment options for the patient.   It used to be a process that was manual and took 1-2 weeks and a lot of time from a human.  This limited the number of patients we could help and in some cases, delaying our suggestions until it was too late to implement.  With malignant brain tumors, speed is of the essence.   Now with this new system, the patient journey is automatically created quickly, and the AI program figures out the preliminary treatment options report immediately.    We can then take that report and evaluate it with our medical experts and virtual tumor boards (which feeds back into the AI system to make future reports better), to produce a finished report in much less time.    For those that need to make decisions immediately, that preliminary report will be produced in time and is usually pretty good.

This system is free to use for patients and doctors. It is like getting a free second opinion from a group of experts. For doctors, it also saves a vast amount of time to have the records organized.   I participate in a few tumor boards, and a common problem is the person presenting the case is not completely familiar with the entire patient journey. When a question is asked, they have to flip through the electronic chart looking for date or procedures or tests.   This wastes the time of all of the participants who don't have time to waste.  With the patient journey, everything would be at their fingertips.



11/04/22 Webinar on Sonodynamic Therapy for the Treatment of Malignant Glioma to be presented Monday, Nov 7, 2022        

  Sonodynamic therapy is one of the most promising new treatments available for brain tumors.    Dr Agarwal recently opened a new clinical trial for a new device that can perform this non-invasive procedure.  I have high hopes for this treatment!



10/27/22 Webinar on Sonodynamic Therapy for the Treatment of Malignant Glioma to be presented Monday, Nov 7, 2022        

 Sonodynamic therapy is one of the most promising new treatments available for brain tumors.    Dr Agarwal recently opened a new clinical trial for a new device that can perform this non-invasive procedure.  I have high hopes for this treatment!



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