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CTAD Poster
poster
ARIA-H, microhemorrhage (%) 38 (6.9) 88 (16.2) 102 (18.6) 31 (5.7) 85 (15.5) 98 (17.6)
Human data, page 49:
BIIB presentation
Can you link this failed science? Tia
https://clinicaltrials.gov/ct2/history/NCT02756858?A=1&B=3&C=merged#StudyPageTop
click the link and scroll down. 2018 dates were changed to 2020. (I personally think they updated the wrong version, which is why it is somewhat confusing, but nevertheless, it was recently updated to 2020).
Hoping for some commentary on....
Well, the other week, we received a post that had an update from AVXLs PR firm (see post#218596). That update included...
It was pointed out the the 2b/3 for Alz has an updated timeline. Next I noticed a change in the Alz 2a extension trial. That is 4 updates on the same date. This is getting me thinking... anyone else have thoughts for why all at the same time?
What I am the most perplexed by is,... the trials should be running independently. Last week someone posted "enrollments curtailed a bit with FDA independent regulatory agency reviews". Why would both trials enrollment be curtailed? Also, why would both trials be updated with new timelines at the same time?
What will you do with all of your spare time?
I'm really rooting for A 2-73 to cure all kinds of neural disorders.
Can anyone help shed some light on what this means?...
Lots of posts regarding AVXL are fiction. This one included.
No it won't. No 10-Q this quarter. 10-K will come out 2nd week of December.
Clinical trials was updated for the US Rett trial. The only change I noticed was total enrollment changed from 15 to 21:
https://clinicaltrials.gov/ct2/show/NCT03758924?term=anavex&draw=2&rank=4
I think someone (maybe flash) posted the PDD clinical trial from a European site that had the 10 and 20 mg listed.
My recollection from ALZ 2a is that 14 mg is the calculated minimum dose for efficacy in ALZ. Now we are starting to see 5 mg work well for Rett, so to me, this seems increase chances of efficacy in PDD.
Curious what everyone thinks regarding the dosing in the PDD trial now? I mean Rett was only 5 mg. PDD was 10 and 20 if I'm not mistaken...2x and 4x the dose. Thoughts?
Edit: Also, 14 weeks vs. 7...?
This is a fantastic post. Thanks so much for finding this!
My eyes, your eyes, our eyes need to focus on one particular thing...
Seizures
If we reduce seizures,.... HOLY COW
fingers crossed for Friday
I think concrete information is as unlikely as attaching value to "very"s...
Trial sites in AUS are included in the PDD trial:
https://clinicaltrials.gov/ct2/show/NCT03774459?term=anavex&rank=2
Same trial, Spain and AUS sites... so definitively same protocols
Beautiful!
My only change would be...
They are doing it this way - not to save money, but to give investigators access to trial data without breaking the blinding.
Edit : I read you post again and I get your point. Saving money by not having to run another trial. I fully support you post, but left my old reply just to avoid confusion.
100% agree
So, what is most peculiar to me is...
Missling's explanation " based on the request from investigators in AUS" - sorry, more of a paraphrase, not a quote.
Well, with a double (quadruple?) blinded trail, investigators in AUS don't have access to the trial data, so...
Were they interested before the trial started? only during the trial? only when enrollment reached a certain point?
Why not do a separate trial in AUS, like Rett with AVATAR?. If slow enrollment, well, they expanded sites in Spain at the same time...so even if enrollment slowed in Spain, the extra sites there alone (+19 already recruiting) should have filled the trial in relatively short order.
Why not just do a separate trial in AUS?
Juggling vpns can be a hassle. After iPix inks it’s next deal, those confused souls will pull a Houdini
My goodness, this looks like it could explode upwards again.
Glad, I read this a second time. I almost thought something HUGE was coming tomorrow. Boy do I feel silly now
LOL. Then I won't hold my breath. I will wait until the meter reads "very, very, very, very" before making any more prognostications
for now let me rephrase...
we will learn of US rett full enrollment..... soon.
Kinda of, yes. I think they opened up a hospital where they knew they had a patient or 2 close by.
Separately, I think the clinical trials website was updated after the site had been open for a period of time already.
If you look at the inclusion criteria, under eligibility, you will see it is still: "Aged ≥ 18 years, inclusive", so this is not part of < 18 upcoming trial.
I think this fits nicely with the Janney Healthcare presentation coming next week with updates. I now suspect we will learn the US trial is 100% enrolled.
US Rett trial added a new site:
United States, South Carolina
Greenwood Genetic Center
[Recruiting]
Greenwood, South Carolina, United States, 29646
Contact: Steve Skinner, MD
https://clinicaltrials.gov/ct2/history/NCT03758924?A=7&B=8&C=Side-by-Side#StudyPageTop
From the conference call transcript, Missling stated that most of the patients are close to 18. I believe that it will be easier to enroll < 18 year-olds than the current > 18 year-olds.
The trial will be international according to the PR, so, yes, that would drastically speed up enrollment.
Also, note the mention of 3 weeks, which is different than the Part B, which is 7 weeks.
I'm not trying to argue, I just think...
Part A - everyone participates in the PK portion for 3 weeks.
Part B - placebo controlled, efficacy measured over 7 weeks of treatment.
I think this was discussed a couple weeks ago and clarified in a PR. The part A is guaranteed because all of the 6 enrolled are part of the PK cohort. Part B in the blinded, which was not mentioned in the FB post.
I think fast track has a bit more meat than:
I have a guess.
Well, after 1 year, they finally expanded the number of sites in AUS for Alz. We also all know that Missling has stated that sites in the US are part of the long term plan for Alz. So maybe, we are getting close.
My guess is that AVXL has APPLIED for fast track, but just can't comment on it yet because it hasn't gotten the approval yet.
Kinda reminds me when we knew the company was granted a patent for Anavex plus, but it took another month or 2 for the patent to be formally issued, therefore, the company couldn't comment for a period.
Just my guess.
Just to keep this topic warm, I'd like to add an excerpt from the Q3 transcript...
"Lastly, a recent third-party peer reviewed scientific publication titled Neuronal Sigma-1 Receptor signaling functions and protective roles in neurodegenerative diseases, details the mechanism of action of sigma-1 receptor, S1R and references ANAVEX 2-73 among the relevant sigma-1 receptor ligands.
The paper summarizes, in conclusion, sigma-1 receptor is incredibly versatile in its ability to foster neuronal homeostasis in the context of several neurodegenerative disorders. We believe that this comment is a confirmation that Anavex is on the right track pursuing this very promising therapeutic approach for targeting patients with devastating rare diseases as well as the largest unmet medical need of aging population, which is Alzheimer’s disease and Parkinson’s disease."
Sure seems to me like the company sometimes comments on articles from third parties.
Alan,
I just wanted to remind everyone of something else that's sitting on the backburner. Yes, the dates are a bit stale, but not the concept. Which deal will come next ??
"Brilacidin—Dermatology Formulation Development
Brilacidin has successfully completed Phase 2 trials in Oral Mucositis (OM), Inflammatory Bowel Disease (IBD) and Acute Bacterial Skin and Structure Infection (ABSSSI). A drug with broad platform potential (pdf), Brilacidin’s innate properties and modes of action, as well as additional pre-clinical work, support the drug’s potential for topical application in dermatology, including: Atopic Dermatitis, Acne, and Hidradenitis Suppurativa. All are areas of large unmet need and comprise highly lucrative markets.
To further these efforts, the Company is in negotiations with a leading drug formulator to develop topical formulation(s) of Brilacidin for these three dermatology indications, starting in 1H2018. The goal of the negotiations is to reach terms on a strategic partnership for addressing these markets. The formulator brings an impressive track record of developing products that have earned billions of dollars for global pharmaceutical companies.
For a discussion on Brilacidin’s potential as a topical agent in dermatology, please read more at the following link:
“Brilacidin’s Potential Application in Dermatology”
Lol, I almost spit out my drink ??
No problem. Just want to make sure we are on the same page.
Nothing that I sent would suggest they are running behind and that's not my point. The "3 week" dosing, Part A, and guaranteed dosing do not exist in the record.
The "Part A" seems to suggest we are doing more than one "Part".