Question: Why aren't they keeping the Ph 2 patients on bryostatin if results were so good? Why are they only going to put the Ph 2 patients back on bryostatin AFTER the drug has been approved? Why not do like Anavex and just immediately extend the Ph 2 trial for those patients that want to continue on the drug in order to track them for longer and avoid a break in treatment? Very strange. Could it be Neurotrope fears if they keep the patients on the drug for longer than 3 months their scores will decline or, even more likely, side effects will appear?
Lets say we accept the notion that bryostatin is safe in cancer patients. So what? This trial is for ALZHEIMERS patients. There's a difference. Alzheimers patients may experience seizures as the disease advances and also behavioral/psyche instability. Synaptogenesis is known to bring on severe, debilitating seizures and behavioral/psyche changes in Alzheimers patients. It increases the probability of those adverse events. If Neurotrope would do a proper trial for longer than just a single dose or 3 months, I expect these adverse events would emerge. I'd expect that bryostatin would increase the incidence of seizures and psyche disturbances in patients with moderate to severe Alzheimers. If Neurotrope conducted a large year long trial of bryostatin for Alzheimers, I think there would be a significant chance that the trial would be halted due to incidences of severe adverse events.
Case in point, compassionate use patient Jenni Spencer experienced debilitating seizures after she went on bryostatin. She often had to be rushed to the ER during these events. During one of the seizures, I believe, she aspirated, and that is what caused the pneumonia which prematurely took her life. Would she have experienced those seizures if she had never gone on bryostatin, or experienced them to a lesser frequency and degree? A responsible, properly designed trial would have given us a better indication of the drug's safety. As it stands now, and even after Ph 2 and Ph 3, we will not know. Neurotrope was indeed shrewd to reduce the trial length for Ph 2b from 6 to 3 months and to plan the Ph 3 to be only 3 months. Sordid and suspicious imo. I've never heard of any prior Alzheimers trial lasting for only 3 months, not in phase 2, and certainly not in phase 3. And the strange handling of allowing the Ph 2 patients to continue receiving the drug, but not until AFTER bryostatin has received FDA approval, which would be a couple years from now! Makes no sense.
The other problem with bryostatin is that it does not address, nor correct, the underlying neurodegenerative disease process going on in Alzheimers. For example, it will not save the microglia and oligodendrocytes, which are the supporting framework for neurons. I do think bryostatin may mask cognitive symptoms, for a time, while the underlying neurodegenerative process continues. The question is, will it create other symptoms during that time, even more debilitating or lethal than cognitive decline?
News 
Market Data 
Discover 
