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12/09/16 NW Bio Provides Update About Phase 3 Trial Of DCVax®-L for Newly Diagnosed Glioblastoma Multiforme Brain Cancer        

Very exciting news.  Nobody knows why the trial was placed on hold. Usually that is a bad sign but there are many reasons a trial can be placed on hold that have nothing to do with how good a treatment is.  See www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm .  I doubt it is for safety reasons, as there were no safety issues at all in the first few trials and in similar trials. That is the one we would worry about if it were true.  There are many other reasons. One possibility is that the FDA thinks that the trial will not prove anything.  There has been arguments back and forth about appropriate endpoints. At one time the FDA allowed progression free survival as an endpoint, but then the Avastin trial showed excellent progression free survival but no increase in overall survival, so the FDA changed its stance and said it wanted overall survival as an endpoint and that progression free survival is not enough. This happened after the trial was designed. The primary endpoint is progression free survival.  This trial allows patients in the control group to cross over and get the vaccine when they have a recurrence.  This messes up the endpoint of overall survival because you will be comparing people who get the vaccine to people who get the vaccine.  The FDA may think it is futile to try with the current design and may want the trial redesigned and done over again, which would probably be too expensive and lead to abandoning of the treatment.  I would protest that it is unethical to not allow cross over for the control group. (Let alone that it is unethical to have a control group in the first place).

 

 

Anyway - this press release says they have stopped enrollment in the trial and will just analyze the results they have.  They already enrolled 331 patients, which should be enough to tell how it looks. IF it shows a progression free survival benefit, we will be fighting to get it approved based on this trial and hopefully not have to go through another phase 3 trial.




12/07/16 Take a survey - get $75!        

 We have worked with these people before.. make sure to tell them you were refered by the Musella Foundation and they will also make a donation to us!

 






12/07/16 First report of tumor treating fields use in combination with bevacizumab in a pediatric patient: a case report.        

 The FDA approval for Optune limited it to use in patients 22 and old because that was the youngest patient in the trial and it hasn't been tested on younger patients. Obviously, it should help younger people.  It can be prescribed for pediatric patients, off label, but insurance companies might try to reject it based on that FDA label restricting age.  Reports like this help us fight the insurance companies!

I think the only real limit is the size of the head - the arrays are large and won't fit on a young child.




12/01/16 New edition of the "Brain Tumor Guide for the Newly Diagnosed"        

 Pleased to announce a new version of the guide!  The big change is the inclusion of a section on Optune. There were many smaller changes - worth taking a look at again even if you read it before.




11/30/16 Israel firm has high hopes for new cancer-busting drug        

 They reported great phase 2 trial results - a doubling of the % of recurrent glioblastoma patients alive at the 1 year point, compared to historical controls. They also showed a great dose response curve, which indicates that the treatment effect is real. They are now doing a large phase 3 trial for recurrent gbm. https://virtualtrials.com/Clinical_Trials_Details.cfm?nct=NCT02511405




11/26/16 Society for Neuro Oncology annual meeting, Scottsdale Arizona, November 17-20 2016        

 The SNO meeting is the most important brain tumor meeting of the year.  There were an overwhelming number of excellent presentations. This is Stephen Western's (our medical writer) thoughts on the most important ones.  We will be discussing them in our online support group, braintumor-treatments (https://virtualtrials.com/braintumor-treatments.cfm).  Feel free to join the conversation and add your highlights!

These presentations show steady progress. We are getting close to a major breakthrough. I have been going to these meetings for many years and have never seen so many talk about 8 to 10 year and even longer survival in so many patients.




11/25/16 Clinical and Pre-Clinical Data on Mustang Bio’s MB-101 (IL13R?2-specific CAR T cells) for the Treatment of Glioblastoma (GBM) Presented at the 21st Annual Meeting and Education Day of the Society for Neuro-Oncology        

 CAR T Cell therapy has been one of the most promising therapies in other types of cancer (although a large CAR T Cell trial for leukemia was recently placed on hold due to a few treatment related deaths). Here the researchers bring it to GBMs, and shows early signs of it helping.  More work needs to be done to optimize the delivery and the targets (Other researchers are using CAR T Cells targeting EGFRvIII see clinicaltrials.gov/ct2/show/NCT02664363) .  This study targeted IL13Rα2, which is another good target, but neither target is presnet in 100% of tumors. Perhaps combining them would reach the majority of patients.




11/25/16 ZIOPHARM Announces Clinical Data on Ad-RTS-hIL-12 Demonstrates Survival Benefits in Patients with Recurrent Brain Cancer        

 Very impressive results for a new type of gene therapy.  




11/24/16 Dr. Reardon on the KEYNOTE-028 Trial of Pembrolizumab for GBM        

Pembrolizumab (Keytruda) is approved for other types of cancer and can be used off label for GBMs.  This shows pretty good results, but it is a small trial and more research needs to be done.




11/23/16 Help Us Better Understand Glioblastoma Multiforme (GBM) Patient Experiences        

 This is from our friends at the Patient Alliances. They are looking for patients or caregivers to fill out a survey.   Please help out! They are making a donation to the Musella Foundation to encourage people to help!  If you contact them, tell them the Musella Foundation referred you!




11/21/16 ImmunoCellular Therapeutics (IMUC) Announces Presentation of Updated ICT-107 Phase 2 Data in GBM        

 Amazing long term data presented for the phase 1 trial of ict-107.  This was a small trial (16 patients) for newly diagnosed gbm patients.  Results:19% of patients had long-term remission of greater than 8 years. Also, 38% of patients demonstrated long-term survival of greater than 8 years.  At the time the trial started, expected survival was less than 18 months for standard treatments.   A subsequent larger trial showed early results that was good but not this good.  Hopefully as the data matures, the tail of long term survivors will jack up the average survivals! This is a relatively simple treatment with minimal side effects.




11/21/16 Society of Neuro-Oncology Annual Meeting Abstract Now Available Online!        

 I just got back from this amazing conference. It will take me a while to go through all of the materials and I hope to soon present a summary of what we think are the highlights.  We can discuss these in the braintumor-treatments online group. To join go to:   groups.yahoo.com/neo/groups/BrainTumorTreatments




11/21/16 Tocagen Presents Updated Clinical and Preclinical Data at Scientific Meetings        

 This is an  experimental gene therapy that is showing exciting results.   There were many presentations on this  at the recent SNO conference.  Most impressive was a subgroup analysis of the recurrent gbm patients who received the highest dosage ( this is the dose being used in the current trial)   Of 24 patients, 41% had a clinical benefit.   Of these, 3 patients had a complete response and 2 had a partial response where tumors shrunk more than 25%.   All 5 of these patients are still alive now, at 24 to 43 months.   So in that trial, a minority's of patients responded to it, but all of the responders had durable responses that are unheard of with recurrent gbms.  They have improved the delivery of the toca 511 to the tumor so hopefully this trial will do better! 

 

Disclaimer: Tocagen is a sponsor of the Musella Foundation, and the Musella Foundation helped fund some of this research!!

 




11/18/16 Long-Term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Successful Interim Analysis Results and Demonstrates Superior Two- and Four-Year Survival Rates        

 This is what we have been waiting for. The final results of the Optune trial for newly diagnosed GBM.  There was some resistance to accepting Optune as the standard of care because the results presented 2 years ago were "just preliminary". The final results are actually better than the preliminary results!

Now the next step is getting insurance to pay for it. Already most non-Medicare plans do pay for it, but Medicare has been hesitating. We had a petition a while ago to help nudge Medicare toward paying for it.  I presented it to them and we did come close and I think it did help - but we had that problem of results being preliminary.  We are going to try again. I resurrected the survey - and updated it to show current results.  Please sign it and have your friends and family members sign it.  IF you already signed it last time - you do not need to sign it again - it is still valid.  If you aren't sure, email me your name and address and I will check it for you.  Go to https://virtualtrials.com/activism.cfm for details and to sign! 




11/09/16 Musella Foundation Co-payment Assistance Program is now closed to new patients        

  I am sorry to say, the program is now closed to new applicants.  I am trying to raise more money - and will reopen it as soon as we can.

We have awarded $4,025,000.00 to over 800 patients so far with this program!




11/09/16 DNAtrix Announces First Patients Treated in Phase 2 Trial with DNX-2401 and KEYTRUDA        

 This is an exciting combination.  The immunotherapies have had some impressive results in some patients, but not everyone was helped.  Adding a checkpoint inhibitor may allow more - or all - patients to be helped!




11/09/16 New vaccine for brain cancer brings hope to those fighting the disease        

 This is a new vaccine for GBM patients.  Nice video - they say "Doctors say for many of the patients, there is no evidence of recurrence and those newly diagnosed with glioblastoma may be the best candidates for this treatment."  Of course, there aren't enough patients treated yet to prove it works, but it is fantastic to have patients respond for long periods of time.




11/08/16 Posttranslational Regulation of O(6)-Methylguanine-DNA Methyltransferase (MGMT) and New Opportunities for Treatment of Brain Cancers.        

 This is another interesting way to enhance the ability of Temodar to work on patients who have unmethylated mgmt.




11/07/16 Novocure Announces 38 Presentations on Tumor Treating Fields at 21st Annual Scientific Meeting of the Society of Neuro-Oncology        

 It looks like Optune is finally getting the respect that it deserves. When it was first introduced, I would say most neuro-oncologists dismissed it without looking at data, based solely on preconceived notions that it couldn't possible work.  Now, most seem to at least allow their patients to try it, if not encourage them to try it.  The holdouts tell me that the data is preliminary and they will wait for the full report. Well - that will come out next week!  I did not see it yet, but I assume from this press release that it is favorable.  Hopefully that will remove the last doubt that this should be part of the standard of care for newly diagnosed Glioblastomas.

It is very significant that most of the presentations are from researchers not associated with the company.  That shows broad acceptance in the field. 




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