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Displaying Stories 1 to 20 of 6,064
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.
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.
11/21/16 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 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!!
11/09/16 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.
11/07/16 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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