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Clinical trial using bryostatin-1, anybody has any experience
This one seems very promising. There are peer reviewed results from previous phase 2 study where the drug showed very good results.
And now they are trying to duplicate those results on larger ongoing phase 2b study.
I think it's the only active trial for severe patients which may be particularly interesting to many but unfortunately the study is fully enrolled already. But once the results are ready in August/September and if they are positive I assume this treatment will be expedited so that it could become available fairly soon.
Is anybody here familiar with the drug or these trials?
I don't think there's anything that makes it to work just for the severe patients. That just seems to be a way to proceed quicker towards approval. If I would have to guess I would say the company will run trials for earlier phase patients if they get good results from the current trial.
What seems especially exciting is that the amount of improvement they reported from previous phase 2 was bigger than any other drug has ever reported. And the improvement seemed to increase until the end of the trial. So there's a possibility that patients will keep getting even better once they are dosed longer.
Anyway, I think everyone should check the results and I was interested in hearing if anybody have any first hand experience on this drug or have any friends that have talked about it.
The previous phase 2a results were for just nine patients with mild Alzheimer's disease. Neurotrope presented the results as follows:
An additional secondary objective of the study was the evaluation of efficacy following a single dose of bryostatin. As expected with a single dose of bryostatin, there was no measurable improvement in cognition in this mildly impaired patient population. It is important to note that in previous animal studies improvement of learning and memory was first observed following multiple doses of bryostatin.
It is possible that multiple doses would have made their condition better but it may also have made their condition worse (even for late Alzheimer's disease lower doses work better than higher doses). I suppose at some date in the fairly distant future, Neurotrope may come back to this "population."
In any case, when the company began to see improvements in compassionate use patients with late stage Alzheimer's disease that is when they began to test the drug for later stages in the disease. They saw improvements in moderate to severe Alzheimer's patients not taking Namenda, but there were also some improvements in some individuals taking the placebo. The common element in the placebo and the drug group was a compound called povidone (polyvinylpyrrolidone) which increases the stability of antioxidants. In the end, bryostatin may show a statistically significant improvement in cognition for moderate to severe Alzheimer's disease over placebo, but that is what we are waiting to see for certain.
I think they chose the severe cases for two simple reasons.
1. There's no other treatment potent enough to even try to treat this patient group. So there's essentially no options and no competition. And therefore the path to approval is quickest in this group.
2. It takes just a relatively small amount of patients and a short period of time to prove the efficacy in this patient population. So they save time, money and can get the treatment available for patients sooner.
If they can prove the efficacy for severe cases, the company and FDA will certainly expedite the treatment to cover mild cases as soon as possible. And after the first proof of efficacy they will have the resources to do it or most probably bigger pharma company will buy them out and will take care of pipeline expansion.
But all that will happen only if they can get positive results from the current confirmatory trial. And since the results so far have been better than any other treatment has ever generated, it's really very exciting to see what those will be like in the Summer. Positive results could offer immediate hope for all patients and caregivers that are dealing with disease that is too far progressed for anything else to offer any help or hope.
Overall, here is a positive report about the effects of bryostatin-1 on late Alzheimer's disease.