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This is great news. I was worried that they would remove the approval based on the study mentioned. The study showed "no significant increase in overall survival". That study did not take into account how Avastin is used in the real world. In the real world it is used in combination with many other things and is a very useful drug. Our virtual trial is tracking the combinations. One that looks exceptionally good (although only 4 patients used the combination) is Avastin plus Optune. 2 of the 4 patients died, but they survived an average of 30 months. The other 2 are alive - one for 22 months so far and the other an amazing over 8 years.
This is a very exciting new treatment for one of the worst diseases that could happen to kids.
This correction just came out. In this article about Avastin for GBMs from 2008, they used the wrong units for the dosage calculation. The correct units are mg per kilogram, not the mg per square meter of body surface area that they originally reported. The difference is huge. For a typical 200 pound 6' tall patient, at 5mg per square meter, the incorrect dose would be about 10mg of Avastin. Using the correct formula, 5mg per kg, it would be about 450 mg. Note that the correct dose of Avastin is not really known. Some use 5mg per kg, some 10mg per kg and some higher doses.
This was only in mice, but it shows that using morphine might make temodar work better.
This research found a new target for these devastating pediatric brain tumors - and there are drugs available that can hit these targets so it may offer hope for these patients. This project was funded by the Musella Foundation. We are saving up for the next step in this research.
This type of research is the key to finding the cure. All of the treatments that have failed phase 2 and 3 trials should be retested to try to figure out why there was enough success in the phase 1 trial to justify the phase 2, then having the subsequent trial fail. Most likely there is a subtype of tumor that IS sensitive to the treatment.
Dr. Peereboom talks about the highlights from SNO
The package inserts warns against using Optune if you have an implanted defibrillator or a programmable shunt. However, they looked at patients in the trials who had these devices implanted and used Optune anyway, and found that there were no safety problems.
The cool thing is that all of the responders still do not have a recurrence. Way too early to be talking about a cure - and it is a small group of patients, but ALL of the IDH1 mutant high grade glioma patients had a complete response, which has lasted 2-4 years so far.
This is a press release about the research I mentioned in a previous news blast article!
After the data that they announced at the last SNO meeting (https://virtualtrials.com/newsarticle.cfm?item=6390), it would be criminal for them to not pay for it.
Dr. Wen talks about the latest clinical trials!
Sounds exactly like what we are proposing, but without the virtual trial concept! We need to get them to consider the virtual trial! See https://virtualtrials.com/fda2017.cfm
This H3 K27M mutation is a marker for the worst prognostic group of brain tumors, and as far as I know, this is the first drug in clinical trials to target this mutation. Aside from being present in some of the worst GBMs, it is present in most DIPG tumors.
This is a gene therapy that is showing some impressive results in an early trial!
I love combinations like this. I believe that it might be impossible to cure GBMs with just a single approach.
This shows that the convection enhanced delivery methods have improved to the point where they can get the drug, on average, to over 75% of the tumor, and it should only get better with more experience. They compare this to the PRECISE trial where the drug only got to about 20% of the tumor.
Here is a link to the poster.
There is a phase 2 clinical trial going on now for this treatment, MDNA55, in patients with recurrent or progressive GBM.
Disclaimer: Medicenna Therapeutics is a sponsor of the Musella Foundation
I am a fan of this drug, which hopefully will be shown to work on unmethylated MGMT patients as well or better than Temodar works on methylated MGMT patients. However, this report is a little too early to tell. Hopefully will have more details at the next SNO meeting.
There is a dose response curve. (Which also should convince the naysayers that the device is effective) The better the compliance, the better the patients do. They have been saying 75% is the target compliance rate but the new data shows that 90% should be the target. Those patients who had a compliance rate of 90% or more, had a survival rate of 29.3% at 5 years, compared to the control group (temodar) which had a 4.5% survival rate, an almost 650% increase in survival rate.
With a compliance of 70-80%, the 5 year survival rate drops to 19.9%. Still much better than the control group... so don't stress too much if you can't hit the 90%, but try.
