So we can look forward to the A3-71, full PDD results in the near term. 100% AD enrollment shortly after that.

OHCH!! Today hurt. Hopefully tomorrow is Tuesday PR day with PDD data!

Regardless of what the SP is doing, we got good news today. A change to one of the three trials probably would have caused long delays or worse! Keep your eye on the ball.

He was referring the Biogen meeting.

Keep in mind how many shares and options the CEO already has, he could possibly become a billionaire in the not too distant future. He doesn’t have a real good reason to buy more stock than he already has.

$16 today??..or should I say holding $16 today??

Here is a DSMB review for Rett back in 2019.
_________________________________________________________________________________________

Anavex Life Sciences Reports Recent Data Review by the Independent Data Safety Monitoring Board for its U.S. Phase 2 Clinical Trial of ANAVEX®2-73 in Patients with Rett Syndrome



NEW YORK – July 31, 2019 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that the Independent Data Safety Monitoring Board (DSMB) for the Company’s U.S. Phase 2 Rett syndrome study of its investigational compound ANAVEX®2-73 (blarcamesine) has completed its recent pre-planned review of the preliminary Phase 2 study data.

The DSMB reviewed the preliminary efficacy and safety data for the ANAVEX®2-73 Phase 2 Rett syndrome clinical study ANAVEX®2-73-RS-001.

Upon review of the most recent data, the DSMB made the following recommendation:

The DSMB recommendation is to continue the study without modification.

Another solid block in the foundation. A recommendation change in trial would have been a huge setback.
Short term thinking is worried about maintaining a small SP increase.

We will get there! In the mean time, it’s good for the stock to stabilize in the mid teens for a while on no news.

$16 today??

A2-73 as a treatment for high blood pressure.
——————————————————————————————————————
[An additional benefit of the therapeutic regimen disclosed herein is the beneficial control of systolic blood pressure in AD subjects taking daily oral dosages of A2-73 of from about 10 mg to about 50 mg. Systolic blood pressure was monitored over the first 25 days of dosing. A1-41 and A19-144 are similarly useful therapeutics.

[0075] Table 3 shows that A2-73 therapy significantly reduced systolic blood pressure in hypertensive subjects with greater reduction for increasingly hypertensive subjects. And further surprisingly, systolic blood pressure rose is subjects that exhibited high-normal systolic blood pressure.

Something leaked???

$16 today??
Someone on stock twits reported the Charles Schwab upgraded AVXL to BUY but I couldn’t find it anywhere.

And the great thing is, the even more potent A3-71 is coming up next on the pipeline! I am thinking it might even have curative possibilities in many indications.
And then there is 1066 . A whole other path to a blockbuster drug.
I think we are witnessing a tip of the iceberg, small biotech on the verge of becoming a major player in the pharma world!
Many on this MB are about to become very wealthy.

I lost my ash on ambs. But it is how I discovered AVXL so I guess it was a blessing in disguise.

https://www.fiercebiotech.com/medical-devices/amarantus-anavex-team-up-for-alzheimer-s-biomarker-dx

Does any “old timers “ remember this deal that never materialized?
This when I first started accumulating AVXL! Been buying ever since. Now holding a pretty sizable position.

I hope you understand that I didn’t mean that the trial administrator isn’t actually “winking “ at the good Dr.., but he IS getting subtle feedback.
If you don’t believe that frrol, I think maybe you trust that rules are always followed 100% to the T. In the real world it doesn’t work like that,

I agree with with what you said about “blinded “ trials Jimmy. I have always contended that secrecy of the blinded trials only goes so far.
In the real world, if patients in a trial are improving, doctors, caregivers and family notice and word spreads.
They might not run to the media with the news, but they talk.
No one can tell me that a little girl with Rett ,after four weeks in the trial, starts having less seizures, having better moods or other improvements, that the parents won’t be able to contain themselves and tell their families and others in the Rett community.
Others on this MB also contend that Dr Missling doesn’t know anything that is going on in the trial until the final results are released to him. I’m calling BS on that!
He certainly doesn’t get daily updates on how he patients are doing but he certainly gets winks and nods to know how the participants are progressing.

Also if approved for Rett, Ana would also be awarded the PRV worth around $100m!!

Shouldn’t that be 1066?

It would be great if they were also testing A3-71 along with 2-73 for the study.
I have always had a feeling that 3-71 will be the shining star of the Anavex line up in the future!

It’s Biden fault not Missling’s!

Let’s just take out the gap at 10.90 and get it over with!

You would have thought that with the new IR firm, they would have taken this opportunity to PR this patent news.

I think you meant Simply Wall Street.

I wonder if they will PR it. Hey, why not?
Or is considered a “fluff “ PR?

Thanks Foodman. Great information! I think I remember you from the old yahoo MB.

Agreed. Annoying

He also briefly spoke about the recent undisclosed new trial, and how they were working with the parents and the advocacy’ group.

Go figure. Nasdaq up 300pts, dow up 651pt. Our one trick pony competition SAVA is up over 6 %

Mods- can someone please skicky MayoMobile’s post?


MayoMobile Thursday, 02/25/21 09:09:15 PM
Re: None 0
Post # of 300798
10th Annual SVB Leerink Global Healthcare Conference:

- All compounds protected worldwide until at least 2030-2039 without patent extensions
- 2:45min: Rett syndrome annual sales are projected to be enough to support development of a full fledged pharmaceutical company (Missilng wants to go alone)
- 4:14min: not the end of the story, these are not all the indications we can treat. Plans to move into Fragile X (5x larger market than Rett Syndrome).
- 4:40min: PDD is a phase 2/3 pivotal study, and POTENTIALLY PD will be pivotal as well (that's new info)
- U.S. Rett Syndrome phase 2 study and full PDD data due late 1st quarter or early 2nd quarter
- 8:00min: Missling explains the MOA. SIGMA1R activation is downstream beneficial with inflammation and tau, but also upstream at the nucleus. It prevents cellular stress before and after RNA interference/disturbance. It does this through chromatin remodeling by preventing toxic RNA expressing into toxic proteins. This explains broad therapeutic approach.
- 9:35min: SIGMAR1R activation is critical, and is going to be further confirmed in a soon-to-be published peer-review journal (PDD)
- 10:37min: Missling mentions Anavex 2-73s benefit in autophagy - the only way cells regenerate themselves
- Very low dose in adult Rett study had very pleasing outcome - this is great because it is harder to find signal in adults
- ALL RNA and DNA are analyzed from ALL patients in ALL studies - allows for faster and more robust future studies
- FDA insists on cognitive and daily living for AD studies. Swapped from MMSE to ADAS-COG in the 2/3.
- SIGMA1 Gene and COMT gene exclusion = much stronger signal. All patients vs placebo, and all WT vs. non-WT will be shown. Expect heavy correlation.
- PDD is a tough indication, three failures recently across the industry. PDD has multiple pathologies which makes it so hard to treat. Our data is intriguing because we had a strong signal across the patients. All domains will be readout in the upcoming data release. Dose-dependent improvement in PDD, 30mg stopped decline, 50 mg improved patient. The 50mg patients "came out of the study with less dementia". 70% of this data has direct correlation with ADAS-COG (AD primary endpoint). REM was also improved and so was digital vigilance and episodic memory. No safety issues.
- Anavex is targeting largest markets. Please note the $277B on the slide is ECONOMIC BURDEN, this is NOT market size. Market size is smaller than economic burden.
- Q. What is the bar for good data in the pediatric study and also for the second adult study? Rett study data to date has been clinically meaningful in the low dose adult study, data in higher dose study will likely be greater which is incredible considering they already have clinically meaningful result (effect size was 1.1-1.2 which is very high).
- Q. Acadia drug, what thoughts do you have on that product? Their published data shows mild effect in the higher dose (in pediatric). Our data shows vastly superior data so far even in low dose. Safety is somewhat lesser as well.
- Q. SIGMA1 gene variant, can you talk about that more? The studies we have done have ALL showed patients responding to the drug, but a few patients have a gene that results in lesser efficacy. This gene is found in 10-20% of the population. These patients do still respond however, and may just need more drug or longer dosing period, or both.
- Q. Biogen drug, what do you think of their data/approval chances? Approval of Adu would be positive for the industry because it shows that a signal clinical study is sufficient for approval. However, if the drug is not approved we will still continu

There must be a good reason to continue open recruiting sites when there are only 40-50 patients left to recruit!
Opening new sites costs money, and frugal Dr M wouldn’t spend money like that without a reason other than speed up the trial by a few weeks.

That crossed my mind. I really hope it wasn’t an over zealoused tweeter at the new PR firm.

The word STOP is very bold for normally very conservative Anavex!
Either the new PR firm has a totally different style than the previous,or Anavex is getting very confident in what they have!

At this point, just take it down and fill the gap at 10.90 so we don’t have that hanging over our heads!

Ya, I’m pretty worried about those 800 shares premarket

Walter E. Kaufmann, MD Is listed as one of the researchers at the bottom of the article...interesting!

So it looks like SAVA’s two phase 3 trials will begin in the second half of this year and will enroll 1000 and 600 participants .
Anavex on the other hand, will complete its phase 3 , 450 patient trial enrollment in the next few weeks!

I would take that report with a grain of salt. Rett revenue in another 2-3 years??
Ya, okay.

So apparently Doc, you didn’t listen to the last conference call?
Why are you so insistent on saying we need yet another, larger AD trial after this one when Missling said otherwise??
Of course I already know the answer.