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Re: sokol post# 47902

Sunday, 01/03/2016 5:31:32 PM

Sunday, January 03, 2016 5:31:32 PM

Post# of 459496
Sokol, I posted the following awhile back regarding Solanezmab. It scared my nurse wife s***less as to the side effects and possible consequences. With so few temporary side effects and when compared to Lilly's AD drug and probably Biogen's, too, Anavex should scare BP as to what it can accomplish in treating this disease.

Lilly's Solanezumab and its risks

Several years ago, I enrolled in the AD study at a major Chicago hospital, not for any memory issues but to be a part of something revolutionary.

When I reached 65 recently, I was asked to become a participant in its Phase 3 trial on solanezumab. The hospital sent the standard consent form with the following "risk" paragraph:

Quote:
RISKS: There are known and unknown risks with this study. You might
experience all, some, or none of the side effects listed. The main risks involve
the study drug. The drug has been used in humans before. Serious symptoms
that have occurred more often in people receiving solanezumab include chest
pain, heart failure, and fainting.
[ORA: 13111101-IRB01-CR01 Date IRB Approved: 3/11/2015 Expiration Date: 3/11/2016
Template Version Date: 02/07/2012 A4 US ICF v3.0 23-SEP-2014
Consent Version Date: 12/08/2014 2 of 18].
There were 43 deaths that occurred during completed long-term studies of
solanezumab. Of these, 24 subjects had received solanezumab and 19 subjects
had received placebo.
Other risks involve study activities such as blood collection, electrical heart
activity tests, brain scans, and spinal fluid tests. Study risks are further
explained in the detailed section below. We take your privacy seriously. To
protect your privacy, we will label your data and samples with a special code.
We will store your name and contact information in a separate, secure place.


Anavex 2-73 risks are: stomach and headaches during the first few days and possible rash.

It understandable why Dr. M would have an easy sell on 2-73 advantages for a trial study, if only from a risk stand point, over Lilly's drug and maybe, Biogen's as well.

P.S. I did not join the trial and told the hospital when it brings Anavex into their trials, I'll jump at joining then.

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