To address some of the BS elsewhere: there is a good reason why recruitment has been slow for the Brilacidin-OM clinical trial.
The exclusion criteria are very strict. Patients accepted into the clinical trial have to be getting their very first treatments for the cancer at the same time. The concern is that someone who has already been through chemo or radiation may have oral mucosa that were damaged by having had oral mucositis once already. Thus, Bril-OM might appear not to work, because there might be no chance of success in damaged mucosa. (Of course, it also might work just the same -- this is an unknown that can be addressed if Bril-OM succeeds in these early clinical trials.)
So, you have to get previously untreated patients, at the major medical centers where the studies are being done. Many people get their first treatments in their local hospitals, and then if it doesn't work, they're referred elsewhere -- to the study centers. So, they're not eligible because they were already treated once. The only patients who could possibly be eligible are the ones who go to the test sites for their very first treatments, which is probably a smaller percentage of the patients.
And, there are other clinical trials going on. What if someone says: you can be in this study to try to make the side effects less bad, or, you can be in this study for an experimental drug that might save your life. Which would you choose?
So I see no reason whatsoever for alarm because of the slow recruiting. The company is addressing that by increasing the number of clinical trial sites. This is a good solution to a problem that one could not have anticipated during the trial design.
Anybody who wants to can post this elsewhere or paraphrase it. Just don't use my name with it or they will delete it.
The exclusion criteria are very strict. Patients accepted into the clinical trial have to be getting their very first treatments for the cancer at the same time. The concern is that someone who has already been through chemo or radiation may have oral mucosa that were damaged by having had oral mucositis once already. Thus, Bril-OM might appear not to work, because there might be no chance of success in damaged mucosa. (Of course, it also might work just the same -- this is an unknown that can be addressed if Bril-OM succeeds in these early clinical trials.)
So, you have to get previously untreated patients, at the major medical centers where the studies are being done. Many people get their first treatments in their local hospitals, and then if it doesn't work, they're referred elsewhere -- to the study centers. So, they're not eligible because they were already treated once. The only patients who could possibly be eligible are the ones who go to the test sites for their very first treatments, which is probably a smaller percentage of the patients.
And, there are other clinical trials going on. What if someone says: you can be in this study to try to make the side effects less bad, or, you can be in this study for an experimental drug that might save your life. Which would you choose?
So I see no reason whatsoever for alarm because of the slow recruiting. The company is addressing that by increasing the number of clinical trial sites. This is a good solution to a problem that one could not have anticipated during the trial design.
Anybody who wants to can post this elsewhere or paraphrase it. Just don't use my name with it or they will delete it.
3
