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Some here have been down this rocky path for too long. We choose not to be victims any longer. It is time for AVXL leaders and staff to perform as appropriate and to move the ball down the field. AVXL shareholders will-can recognize/identify any/all BS and liars by now. Game on.
Can anyone splain wtf is going on? Is this just WS criminals driving SP down while they scheme to load up?
Nice...looking fwd to some up days around here. Thx
xodcode
Ace11...yes, thanks...we are in complete agreement...you called it...excellent.
Any longs here who think (as I do) that last weeks attack/sell off was to get a new bottom established for the expected run which (IMO) is about to begin Monday?
Bingo...that is the beginning of the interview recording I was looking for.
Great find...hope it helps all w/background. If same (long) video then expect Dr Grimmer to begin to peel the core science.
I was very impressed w/the depth and scope (expanded horizons) of his (Dr.G) knowledge-including established CNS diseases . Note: he is not an FDA locked in Amyloid Plaque Homey. I thought him to be a brilliant researcher and that the interview was very well done as they began to peel the CNS Diseases onion.
Thanks and all the best.
Plexrec...this is as close as I can find right now. regrets, not the video that was brilliantly done. this guy (Timo) thinks-presents and talks about multiple variable links like he mixing a salad...brilliant stuff.
BLARCAMESINE IN EARLY SYMPTOMATIC ALZHEIMER DISEASE PHASE 2B/3 RANDOMIZED CLINICAL TRIAL
Presenter
Timo Grimmer (Germany)
Lecture Time
09:10 - 09:25
Abstract
Aims
To assess in early Alzheimer’s disease (AD) patient’s efficacy and adverse events of blarcamesine
(ANAVEX®2-73), an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) designed
to exert neuroprotection through restoration of cellular homeostasis.
Methods
ANAVEX®2-73-AD-004 48-week study was an international, double-blind, multicenter, placebo-controlled
Phase 2b/3 clinical study. 508 patients with AD were randomized to blarcamesine or placebo. The clinical
outcomes (primary, secondary, and exploratory) included ADAS-Cog13, ADCS-ADL, CDR-SB, and CGI-I,
which were analyzed using a mixed model for repeated measures (MMRM) and biomarkers from the A/T/N
spectrum, plasma Aß42/40 ratio and brain volume measured by MRI.
Results
The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48
weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226)
for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early AD.
In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P
= 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while
MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing
treatment to placebo.
anavex_mri.jpg
Conclusions
Among participants with early symptomatic AD, blarcamesine was generally safe, well tolerated and
significantly slowed clinical progression at 48 weeks, which is also corroborated by biomarkers from the
A/T/N spectrum, including plasma Aß42/40 ratio increase and reduction of brain atrophy in several key
regions of the brain measured by MRI.
ClinicalTrials.gov Identifier: NCT03790709.
Hide
It is interesting that Anthony Caggiano, M.D., Ph. D, the CMO and head of R&D at Cognition Therapeutics, a company investigating S2 receptor agonists for the treatment of neurodegenerative diseases, stated on Oct. 16, 2023, “The approval of monoclonal antibody therapies against amyloid beta protofibrils represents an important milestone in Alzheimer’s drug development, but industry experts agree that combination treatments will likely be required to achieve greater impact on the disease.” Dr. Timo Grimmer, an expert in neurodegenerative diseases and a member of Anavex’s SAB, has stated, “We all agree that combination therapy will be needed in the end.” One could argue that Anavex 2-73 is in itself a combination therapy, in light of the multitude of positive effects that it, or S1R agonists in general, have been shown to exert on the cell. This is not to say that it won’t be used in combination with other medications being developed by other companies. I believe it will.
This is excellent news. Dr. Grimmer (as shown on previous AVXL thread) is a WW AD medical-researcher leader example (IMO) . If this presentation work reveals what I "Think it will "...then the combination of Dr. Grimmer skills, excellence of AVXL products-W/research findings will be (BOOOM) explosive WW. IMO, this helps to ensure early approvals by E U Medical leadership. BRILLINATLY DONE.
IMO, this work may (overnight) project AVXL to an CNS world leadership position. . BRILLIANT STUFF ...I PREDICT GREAT THINGS EVOLVING FROM HERE.
IMO, Dr. Grimmer presents the deep knowledge and skills of a "Systems Thinker". (see dr. Peter Senge, M.I.T. Leader)
[Saturday March 9, 2024, Just two weeks from TODAY!!!
BLARCAMESINE IN EARLY SYMPTOMATIC ALZHEIMER DISEASE PHASE 2B/3 RANDOMIZED CLINICAL TRIAL
Presenter
Timo Grimmer (Germany)
Lecture Time
09:10 - 09:25
Abstract
Aims
To assess in early Alzheimer’s disease (AD) patient’s efficacy and adverse events of blarcamesine
(ANAVEX®2-73), an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1) designed
to exert neuroprotection through restoration of cellular homeostasis.
Methods
ANAVEX®2-73-AD-004 48-week study was an international, double-blind, multicenter, placebo-controlled
Phase 2b/3 clinical study. 508 patients with AD were randomized to blarcamesine or placebo. The clinical
outcomes (primary, secondary, and exploratory) included ADAS-Cog13, ADCS-ADL, CDR-SB, and CGI-I,
which were analyzed using a mixed model for repeated measures (MMRM) and biomarkers from the A/T/N
spectrum, plasma Aß42/40 ratio and brain volume measured by MRI.
Results
The trial was successful, since the differences in the least-squares mean (LSM) change from baseline to 48
weeks between the blarcamesine and placebo groups were -1.783 [95% CI, -3.314 to -0.251]; (P = 0.0226)
for ADAS-Cog13, and -0.456 [95% CI, -0.831 to -0.080]; (P = 0.0175) for CDR-SB in patients with early AD.
In addition, validated biomarkers of amyloid beta pathology, plasma Aß42/40 ratio increased significantly (P
= 0.048), demonstrating strong anti-amyloid effects of blarcamesine in Alzheimer’s disease patients, while
MRI revealed significant reduction in brain volume loss, including whole brain (P = 0.0005), comparing
treatment to placebo.
Good luck and GOD bless,/quote]
The entire Placebo (Rett) trial design logic(oversight) was a massive(dumb) move. Should never have happened, IMO. A DO-OVER is imperative. It cannot be left hanging over our collective heads as is. This should/must be a TOP AVXL management priority.
Missling said that he was going to discuss the path forward with the regulators. That sounds like continuing to pursue Rett to me.
The FDA is going to tell Anavex what the path forward will be. Until Anavex has that guidance from the FDA it is in a holding pattern vis a vis Rett
NasdaqGS - Nasdaq Real Time Price
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USD
Anavex Life Sciences Corp. (AVXL)
Following
5.0100
-0.0100
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This sucks. Owning AVXL is not for sissies.
What your not taking into account here is AVXL board members are insiders with full access to data and planning. This gives them the ability to see much further over the horizon than shareholders. I just don't think they are complaining. If there are disagreements they will likely come out at some point.
FUBAR...
Thank you 123...pls keep up your good work.
Any thoughts on where AVXL will close today? Must admit, I have no idea what is going on. No new news that I have seen ??? Strange...w/1.35 Million volume...strange.
5.20
+0.12
(+2.36%)
Pre-Market: 8:53 AM EST
they are buying at the depressed pricing which they have a hand in creating.
I do believe-emphasize what I wrote. I despise liars.
Continued collusive manipulation, by the FUDsters' handlers, provide additional opportunity
Facts!
Plex?
See if this link works...great interview/ brilliant AD researcher
Share
They had a link to an interview video which (I guess) could not be copied-moved. Regrets.
Thx Plex...IMO, this is brilliant stuff...if one owns AVXL then watch this to feel better.
We know the data in Rett's wasn't all they hoped it would be, but it was based on judgement in which the judges had no idea if the patient received the placebo or not. Placebo patients were viewed to have some improvement, I believe that people see what they're hoping to see, so it's human nature to see some improvement even if there isn't any.
Ge is a reliable resource for many here. He often keeps a theme working and will tend to tie loose ends when possible, Some days he acts as a linkage theme.
we'll see..
The Anavex quiet period, when people within the company cannot tell anyone about inside information regarding GREAT NEWS due to SEC regulations!!!
Good luck and GOD bless,
Jon, Thx. Appreciate the effort.
Now is the right time for expertise, money and infrastructure. For Alz and all other trials.
""We could get a big upside surprise coming out of left field but it sure doesn’t feel that way."
Pretty sure one isn't meant to "feel" a surprise coming out of left field before it happens.
bas2020
Now, it looks like they are poised to begin their next round of accumulation, which will raise the price once again, along with short covering. We must be getting close.