Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!
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Det giver åbentbart god mening at køre sine forsøg uden for US. Der er 60% besparelse på den post, og nok ikke lige så indspiste som FDA ... Australien https://www.australianclinicaltrials.gov.au/why-conduct-clinical-trial-australia
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Anavex Helt enig BioShare, men Motley Fool har ellers notorisk været negativ på Anavex og tror faktisk, at de har en hel del følger.
Har ofte haft det indtryk/mistanke, at Motley Fool har været en slags "shortindikator", forstået på den måde, at negative omtale fra MF ofte faldt sammen med et efterfølgende pres på Anavex`s aktiekurs.
Omvendt kunne derfor selv en tyndbenet positiv artikel, signalerer et tegn på at påbegynde inddækning af short positioner?
Men der er nok ingen sammenhæng overhovedet - dette ville aldrig forekomme i US:)
Stoler efterhånden så lidt på US markedet, at man med tiden er kritisk for næsten alt, hvad der kommer af udmeldinger fra div. såkaldte analytikere mm.Så derfor gerne Anavex indlede en dialog med EMA eller Australien - i US kræver det næsten nødvendigvis en BP som partner for at blive anerkendt!
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" Så derfor gerne Anavex indlede en dialog med EMA eller Australien - i US kræver det næsten nødvendigvis en BP som partner for at blive anerkendt!"
Missling har vist kapital til at fedte rundt i 4 til 5 år, så det bliver vel tidligst først i 2025. Spøg til side, jeg er enig i forhåbningen.
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Kursen er ligegyldig (for mig) med mindre man er daytrader.
Data afgør fremtiden og de kommer vel indenfor de næste måneder.
Her er lidt spændende læsning omkring Ariana og Anavex:
#pharma #lifesciences #drugdevelopment #artificialintelligence #ai #neurology #alzheimers #parkinsons | Ariana Pharma
A review published last week by Harald Hampel, MD, PhD, MSc and Team mirrors the development over the past decade of personalized neurology for Alzheimer's and other neurological diseases at Ariana Pharma. Thanks for sharing this great work! Working together with Anavex Life Sciences, Ariana Pharma has identified variant and gene expression patient selection, pharmacodynamic, and surrogate biomarkers for ANAVEX2-73 in Alzheimer's, Parkinson's and Rett neurological diseases. These biomarkers have had a major impact on the other requirements for personalized neurology identified in this paper. https://lnkd.in/deiS-4XS #pharma #lifesciences #drugdevelopment #artificialintelligence #ai #neurology #alzheimers #parkinsons
LinkedIn (www.linkedin.com)
Ved læsning af artiklen i Neurosciences får man det indtryk, at man også benytter Ariane til at vælge deltagerne i forsøgene. Det kan forklare, hvorfor det tager tid at rekruttere til bl.a. Excellence. Fornuftigt at de rekrutterede pts er repræsentative for populationen og antallet er dækkende til analyse af div varianter, man vil analysere selvstændigt.
Glæder mig til at se, hvad der kommer ud af analyserne. Se bl.a. indlæggene under det der linkes til. Cancerforsøg, hvor der er fundet en sammenhæng mellem effekt og nogle biomarkører.
Fremgangsmåden og de analyser der kommer ud af metoden giver efter min vurdering langt større chance for en approval i mindst en delmængde af patienterne. De patienter behandling ikke virker på spilder ikke deres tid og de der betaler spilder ikke deres penge. Win win.
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Anavex Lidt Seeking Alpha og en You tube video med 2-73 i Parkinson.
Enig Solsen - kun data tæller i sidste ende!
Har kun taget en kopi af det der vedr. Anavex, hvis linket skulle lukke for fuld adgang igen.
Anavex: Drug Treatments For Early Alzheimer's Disease
Jan. 17, 2023 5:10 PM ETAnavex Life Sciences Corp. (AVXL)BIIB, ESALF, ESALY, LLY28 Comments
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Lane Simonian profile picture
Lane Simonian
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SummaryAnavex 2-73/blarcamesine at high concentrations in early Alzheimer's disease leads to improvements in cognition and activities of daily living that are largely sustained for 148 weeks in most individuals.
Alzheon's ALZ-801 reduces cognitive decline in ApoE4 carriers by about the same amount as Eisai and Biogen's Leqembi and Aduhelm, but without the risks of brain bleeds and swelling.
Cyclo Therapeutics Trappsol Cyclo by reducing cholesterol levels in the brain inhibits the processes that lead to the onset and at least the early progression of Alzheimer's disease.
These three drug candidates offer the best hope for the treatment of early Alzheimer's disease. In many cases, they may be more effective when used in combination.Anavex Life Sciences Anavex 2-73/blarcamesine
Anavex Life Sciences (NASDAQ:AVXL) Anavex 2-73/blarcamesine is a sigma-1 receptor agonist which inhibits the release of intracellular calcium into the cytoplasm in part by transferring it to the mitochondria. Aricept/donepezil is also a sigma-1 receptor agonist, although it may preferentially bind to acetylcholinesterases. In any case, at high concentrations Anavex 2-73 vastly outperforms not only a placebo at one year (an expected decline of between 4 and 8 points in the Alzheimer's Disease Assessment Scale-Cognitive subscale) but also donepezil (about a 2 point decline in ADAS-Cog scores).
At high concentrations in early Alzheimer's disease and in those with a functioning sigma-1 receptor, Anavex 2-73 led to an average 2 point improvement in Mini-Mental Examination Score at 57 weeks (the rough equivalent of a 4.6 improvement in ADAS-Cog scores). Four out of six patients improved, one remained at baseline, and one declined in this cohort (57 weeks results). At 148 weeks, there was only about a one point mean decline in MMSE scores at high concentrations which would make Anavex 2-73 a disease modifying treatment for Alzheimer's disease (148 week results). The change in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scores was not as dramatic at 57 weeks mostly because there is relatively little change in basic abilities during the early stages of the disease, but the gap grew much larger at 148 weeks.
The phase 2a trial was a very small trial. In the much larger phase 2b/3 trial the combined 30mg and 50mg met the cognitive endpoints as measured by ADAS-cog and CDR-SB (Clinical Dementia Rating-Sum of Boxes) scores (amended CTAD presentation). Moreover, Anavex Life Sciences has said that the findings in this trial were consistent with the phase 2b trial in which the medium concentration group performed no better than placebo but in which the high concentration group performed better than any previous drug or drug candidate for early Alzheimer's disease. In the phase2b/3 trial, those who improved at 48 weeks by more than -.5 ADAS-Cog scores did so by an average of approximately 4 points which is right in line with the high concentration group in the phase 2a study.
Anavex Life Sciences has not released (or perhaps still has not completed) its full data set which has left the company open to various broadsides. However, the only thing that matters is the actual data and how the FDA views it. The negotiations between the company and the FDA may well center around the question of whether there were enough participants in the high dose group to establish statistical significance despite having achieved clinical significance. If the FDA grants accelerated approval, then Anavex would be able to sell blarcamesine, while it undertakes trials in the U.S. with larger numbers of participants taking the high dose. If the FDA requires Anavex to undertake a larger trial before approval that will hurt the company's stock and deplete some of its reserves, although this may be slightly offset by potential approvals in Australia and Europe. In either case, a partnership is likely needed for commercialization of blarcamesine. For investors, it is a matter if it will take a little bit more patience or a lot more patience.
Blarcamesine appears to work as well as it does because it intervenes at a critical junction in the process that leads to the onset and early progression of Alzheimer's disease. By limiting the release of intracellular calcium, blarcamesine produces a myriad of benefits including the following: it maintains levels of neurotransmitters needed for the retrieval of short-term memory, sleep, mood, social recognition, and alertness, inhibits the breakdown of acetylcholine (which is needed for the retrieval of short-term memories), regularizes neurotransmissions, prevents mitochondrial dysfunction, lowers neuroinflammation, allows for the regeneration of neurons, synapses, and axons, and prevents the death of neurons. Perhaps most importantly, it limits oxidation and nitration which is why it ameliorates many of the problems listed above (study). Blarcamesine may also directly limit the influx of calcium further inhibiting oxidation and nitration, scavenge the oxidants hydrogen peroxide and peroxynitrite (ONOO-), and partially reverse oxidative and nitrosative damage, although studies in this regard are inconclusive. In any case, one of the best ways to greatly slow the progression of early Alzheimer's disease is with an effective sigma-1 receptor agonist such as blarcamesine (study).
Blarcamesine can produce dizziness and confusion at the highest dose which caused 17 dropouts and 24 down-titrations in Anavex's latest trial (although giving blarcamesine before bedtime may partially address at least the problem of dizziness), and it is considerably less effective in those with sigma-1 receptor variants. Two questions, then: what treatments might help these type of patients and what combination therapies might help others, especially ApoE4 carriers who progress more rapidly in early Alzheimer's disease?
You tube video:
Dr. Simon Stott fokuser primær på Parkinson, men nævner også Anavex og deres AD fase 2/3:
Fra 10:50 starter omtalen af 2-73.
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Anavex Link til Dr. Simon Stott og 2-73 i Parkinson.
Fra 10:50:
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.. Det er vel lidt af en no brainer ikke at give "accelerated approval", på et præperat som; Har ingen større bieffekt, i et tidlige stadie kan bremse AD. eller sågar forbedre tilstanden! Tiden er den vigtigste faktor her. Her er AI også en meget vigtig faktor, hvem respondere og hvem gør ikke?
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Anavex Fredag er option dag - relativ store spil omkring 10 $.
Relative store spil omkring 10 $ optioner og puts, så formår MM/udbyderne at manipulerer kursen til omkring de 10 $, så vil mange spil være værdiløse og spiludbyderne kan bare inkasserer betalingen for indsatsen!
Dette har vi set gang på gang, selvom det er ulovlig at manipulerer en aktie til fordel for dette højst mærkværdige og i min optik destruktive form for "spil", er dette en fast del aktiemarkedet, hvor de store spillere suger $ ud af de mindre aktører.
Svarer lidt til at Danske spil udbyder et spil på en fodboldkamp, men hvor de selv agerer dommer og kan påvirke udfaldet af kampen!
I håndbold kører der pt en større sag omkring matchfixing - i aktiemarkedet sker dette dog hver eneste dag i mange aktier uden konsekvenser og til langt større beløb! -
Anavex Ingen AA godkendelse til LLY og Donanemab!
Eli Lilly forsøgte at få en acceleret godkendelse på deres fedtfjernelsespræparat i fase 2 i Alzheimer - tilsvarende Biogens Lecanemab.
Dette er dog blevet afvist af FDA, så de må nu afvente deres fase 3 forsøg og køre den traditionelle vej.
Et spinkel håb for at FDA har lidt fornuft tilbage - eller måske har Biogens kritisable tætte forhold til FDA bare været bedre end Eli Lillys?
FDA krævede at min. 100 AD patienter var på aktiv stof for at opfylde kriteriet for størrelsen af patiengruppen - Anavex har til sammenligning 170 pts i både 30 og 50 mg - så selv med 80 % (WT genet) af 50 mg gruppen, havner antallet på ca. 136 pts på højste dosis 2-73, herfra fratrækkes dropouts - stadig tilstrækkelig til at opfylde denne del af en evt. AA ansøgning.
U.S. Food and Drug Administration Issues Complete Response Letter for Accelerated Approval of Donanemab
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the...
(www.prnewswire.com)
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Anavex Ansætter deres 3. tidligere FDA medarbejder!
27 års erfaring fra FDA!
Endnu en tidligere FDA ansat, der bare skal have et lille seniorjob de sidste år på arbejdsmarkedet eller måske en, som har set nogle data og tænkt, at denne rejse vil han gerne med på?
From FB group: Key new hire: Vice President and Head of Biostatistics; Kun Jin. He spent the previous 27 years of his career at the FDA/CDER.
Here are slides from a presentation, Update on Building the Integrative Alzheimer's Trial Database, that Dr. Jin gave in 2017 at Clinical Meaningfulness in Drug Development for Early Alzheimer's Disease - An FDA/Alzheimer's Disease Allies Meeting sponsored by ACT-AD (an organization that Anavex has long been a member of): act-ad.org/app/uploads/2007...
And here's that event's description on ACT-AD's website (bonus, if you search Anavex there you'll find a couple interesting early interviews with Missling from 2015/2016) act-ad.org/event/test-event...
Bullish
Show MoreLidt af hans arbejde:
https://act-ad.org/app/uploads/2007/04/Kun-Jin-ACT-AD-slides.pdf -
Av sava 20% ned på data fase 2
Tasso har du en forklaring på det. I er så gode til forklarer hvad der ikke var så godt -
Anavex. Samtale med IR - med alle forbehold!
Deres nyansættelse af den tidligere FDA medarbejder, Kun Jin, var den ledende statistiker hos FDA for både Aduhelm og Lecanemab! - virker umiddelbart som noget af et scoop af Anavex. Han må om nogen vide, hvad der skal til for at overbevise FDA! - og har han set data fra 2-73, der giver ham troen på, at Anavex har fat i noget, som er værd at droppe FDA til fordel for en ansættelse i lille Anavex? - Er sikker på, at han kunne have fået en betydeligere større løn hos f.eks. Biogen eller nogen af de andre BP´er - men han valgte Anavex!!!
Talked with Clint from Anavex. .
New hire.. . He said kun jin (Anavex new hire from FDA)came from the Aduhelm and Lecanemab trials with the FDA. Kun was the lead statistician at the FDA with both of those drugs. Clint said he is an awesome new hire. Also clint said every time Blarcamesine data comes back it looks better and better. . He said he would expect Anavex to file for Accelerated Approval during this year. . I said Lilly just took 100 patients. He said Anavex could do that also and all of that makes Anavex pleased how easy the FDA wants to make Accelerated approval here. He laughed ? about SAVA and said yeah they are 3 or 4 years behind Anavex. . Sava is not a competitor to Anavex. Partnership is something that is certainly on the agenda -
Anavex Poppelkongen - SAVA data.
Synes ikke resultaterne var så dårlige, som det blev afspejlet i markedsreaktionen gav udtryk for.
Det er dog åbenlys, at SAVA i dette åbne forsøg på ca. 200 pts. tog munden lidt for fuld, da de også tog moderate AD patienter med, der stort set ikke responderede på det aktive stof. Dette betyder, at de i realiteten halverede størrelsen og styrken i forsøget - og hvad værre er, så har de også taget samme patientgruppe med i deres 2 større fase 3 forsøg, der nok kommer med resultater i løbet af 2024/25.
Svagheden er også, at dette fase 2 forsøg er åben og uden placebogruppe, samt at usikkerheden synes lige i overkanten.
Har vedhæftet et You Tube indlæg, som ser noget mere positiv på resultaterne fra SAVA.
(Har selv et lille frimærket i SAVA og afventer udviklingen i casen, men har ikke stor tillid til deres grådige ledelse, der flere gange har udbetalt store bonusser til sig selv - modsat Anavex, som primært aflønner i optioner - dvs. ingen bonus, hvis resultaterne udebliver)Anavex har i min optik været noget mere grundig (og derfor langsommere) i deres udformning af strukturen i deres forsøg.
De har tidligt erkendt, at der skal sættes tidligt ind i AD for at kunne opnå et brugbar resultat og reel effekt i patienterne og har derfor udeladt moderat AD-gruppen, men har koncentreret sig om tidlig og mild AD-stadiet.
Har man set skanninger af hjerner med Alzheimer, er det tydeligt, at en fremskreden forløb i AD med markante indskrumpet og "afpillet" hjernevæv ikke har har store muligheder for en bare minimal effekt, uanset hvad man måtte behandle patienterne med - skaderne er simpelthen for omfattende.
Anavex understreger derfor også, at når 2-73 skal have en effekt ved at stimulerer S1R, så skal der naturligvis også være en vis position S1R tilbage i hjernen på patienten.
Derudover har Anavex altid haft en placebogruppe, uanset størrelsen på forsøget.
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