Synaptogenix Inc (SNPX)

[blu_1]

Review of bryostatin-1 by amstocks82:

1) "bryostatin-1" is given as an intravenous infusion. This means that there is significant expense associated with dosing patients. Due to bryostatin-1 being an infusion, it makes it more difficult to get an appropriate dosage. That is because an infusion goes directly into the blood. It is difficult to give infusions every day. That means that sufficient bryostatin-1 must be given to last several days each time it is given but they can't give so much that it causes severe side effects. In the study, they gave 7 doses in 12 weeks. They started with a dose every week for two weeks (loading phase) and then one dose every two weeks. This was administered by an IV over 45 minutes. See the clinicaltrials.gov summary of the trial:

https://clinicaltrials.gov/ct2/show/NCT02431468?term=Neurotrope+Bioscience,+Inc&rank=1

2) The dosage and method of infusing bryostatin-1 has been studied since the early 1990s when it was given to cancer patients and has been studied for Alzheimer's disease for over 14 years

http://www.tandfonline.com/doi/abs/10.1081/CNV-120025095?scroll=top&needAccess=true&journalCode=icnv20&;;

3) Brystatin-1 has been found to have several adverse side effects. The side effects are one of the reasons that bryostatin-1 requires a much longer testing period. The side effects of bryostatin-1 are age dependent getting worse as the patient ages. http://onlinelibrary.wiley.com/doi/10.1111/j.1527-3458.2006.00001.x/pdf,
( http://www.tandfonline.com/doi/pdf/10.4161/cbt.1.4.17see page 411 for toxicity summary )
( https://rd.springer.com/article/10.1023/A:1020694425356 )

A2-73 works well as a tablet or pill taken by mouth and does not have similar negative side effects as does bryostatin-1. There is no question that if bryostatin-1 and A2-73 had similar beneficial therapeutic impact on patients Alzheimer's disease and other diseases of the brain and nervous system, that A2-73 would be the blockbuster drug and bryostatin-1 would be something doctors would regrettably have to try if A2-73 didn't seem to be working.

The lack of major side effects makes testing A2-73 much simpler. With bryostatin-1, the side effects mean that months of follow up are needed to verify that the drug has not caused adverse side effects to each patient. Additionally, side effects limit the amount of time it can be given for.

The fact that A2-73 is given by mouth reduces the costs hugely. An infusion center will charge $800 to $1200 just to give an intravenous infusion. With A2-73, the patient or patient care giver can be issued a bottle of pills with the typical instructions printed on the bottle and on a handout.

Bryostatin-1 is typically given for a short time only due to side effects that get worse over time. In this case, it was given for 12 weeks. If Bryostatin-1 works as well as A2-73 for those 12 weeks, it would not be as effective as A2-73 in the long run simply because A2-73 can be given for much longer periods and can therefore be benefiting patients over a longer period of time.

The next reason that I think bryostatin-1 probably does not have the same impact is because bryostatin-1 is a natural product that scientists/doctors noticed seemed to have a positive neurological impact. It was not created to have an impact on Alzheimer's disease. The impact it does have is an accident of nature just as the side effects are accidents of nature.

I do think the phase 2 results show bryostatin-1 show it has some utility but I think Anavex2-73 is as good or better with fewer side effects and a much more cost effective treatment.

The company is working on an oral version of bryostatin-1 but it is not yet ready. And they can now synthesize the drug in the lab. If they get an oral version working, they will have to restart in the Phase I trials.