Synaptogenix Inc (SNPX)

[grich1]

Anavex having problems recruiting in AD. ( Added Dr notes)

Trial is 450 patients. First patient dosed 8/28/18. Recruiting at 16 sites. Other sites enroll 7 to 10 patients. #1 site is at 31 goal is 50. Dr said recruiting will go into early 2021.

Math not adding up to 450.
Give #1 site 50 which is top end of goal.
Give the other 15 sites top end of their goal of 10 for 150 total.
That’s only 200 patients total.

Looks like we are 250 patients short and again Dr has already admitted recruiting in 2021.

Sorry this news is not good. Drs math is not adding up.

ANAVEX trial- A phase 2b/3, double-blind, randomised, placebocontrolled 48-week safety and efficacy trial of ANAVEX2-73 for the
treatment of Alzheimer’s disease

Associate Professor Macfarlane’s study team has been
involved in testing the ANAVEX2-73 molecule since 2014
and were heavily involved in writing and editing the
previous phase 2a, and current phase 2b/3, protocols.
ANAVEX2-73 is a novel compound that is thought to act on
the sigma 1 intracellular receptor.
Its mode of action is unique in that most (if not all) other
molecules developed thus far to treat Alzheimer’s Disease target
the removal of a single type of toxic protein (either beta amyloid
or Tau). In contrast, ANAVEX2-73 is thought to remove all forms of
misfolded proteins from brain cells.
While involved in the phase 2a study, Associate Professor
Macfarlane and his team saw positive (and at times drastic)
increases in cognition and functioning in study participants, and
are pleased to be involved in the phase 2b/3 study. The study will be
recruiting throughout 2019 and most likely 2020 and into early 2021.
Some key achievements of the HammondCare site in relation to
this study include:
1. Associate Professor Stephen Macfarlane has been appointed
as the global study lead for this study
2. The Malvern site was the first site in the world to be initiated
3. Ours is the global No.1 recruiting site (most sites average 7-10
patients per study, whilst Malvern already has 31 patients on
study and aims to recruit 40-50 patients)
4. This trial is currently being conducted at over 15 sites globally
and will run for another 24 months



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