ANAVEX. NY TRÅD NY TRÅD over 100 % indrulning i Alzheimer!
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De to links er fra en der kalder sig MayoMobile, en anden af de rigtig skrappe drenge på IHub.
Anavex 2-73-RS-001 Adult Low Dose Rett Trial (U.S.)var den første du linkede til Hyst, en fantastisk opsummering af data af MayoMobile og fantastiske resultater de opnåede som lover rigtig godt i AVATAR (+18 år høj dose) & EXCELLENCE (5-18 år piger optimeret doser).
Jeg håber at de snart er fuldt indrullet i disse 2 meget vigtige forsøg.
Håber på nogle nyheder i denne uge, det er snart en måned siden.
Bliver også spændende at se data fra konkurrenterne og hvad det betyder for aktie kursen for Anavex.
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Saa har vores ven Falconer "tydet" en meget meget tung report.
Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study in Alzheimers.
Jeg har vedhæftet reporten i bunden, jeg fatter ikke et pip af den men Falconer gør den noget nemmere at tyde.
falconer66a Monday, 07/26/21 11:01:59 AM
Re: plexrec post# 322719 0
Post # of 322782Pretty deep, but phenomenally significant.
Quote:...could you please take the time to read (perhaps you have seen before) and give us the conclusion you reach what the article is saying.
insert-text-here
Well, thanks. Once again I turned to the paper, read it closely, with the goal of explaining what was investigated, and what was found. But, as anyone will quickly perceive when trying to read it, the article is extremely info-dense, with information not familiar to those not so competent in cellular biology, etc.
I first tried to condense and summarize the article for readers here. But after about the second page, of multiple big paragraphs with lots of terms that had to be explained, I gave up. Few would want to read much past my third paragraph. Scientifically arcane stuff; very hard to explain in a few paragraphs. So, let me tell what I found; what the paper discovered.
The study analyzed the "exome," the genetic nucleotide sequences of participants, looking for portions of DNA (genes) that would correlate with therapeutic responses. Pretty advanced stuff, yielding very precise data; answering the question, "What genetics will allow blarcamesine to work, provide therapeutic results?"
I found this statement to be (for me at least) the most significant: "...the higher blarcamesine (ANAVEX2-73) mean concentration arm had improved therapeutic responses of 78% and 88% in adjusted MMSE and adjusted ADCS-ADL, respectively, relative to the low/medium arm at 148 weeks (P-values < .0008 and <.0001, respectively). In addition to time, APOE e4 status (P < .0001), and blarcamesine (ANAVEX2-73) mean concentration were significant predictors."
Simply, for 78 to 88 percent of the humans being tested blarcamesine provided extremely significant therapeutic improvements.
First were the Mini-Mental State Examination (MMSE) numbers. The MMSE test runs like this: "Ask for the date. Then specifically ask for parts omitted (e.g., "Can you also tell me what season it is?"). One point for each correct answer. Ask in turn, "Can you tell me the name of this hospital (town, county, etc.)?" One point for each correct answer." Simply, it's a test of normal thinking, cognition skills-exactly what's missing in those with Alzheimer's.
The ADCS-ADL testing assesses the competence of patients with Alzheimer's Disease in basic and instrumental activities of daily living. The other deficiency factor in people suffering from Alzheimer's.
Then, of course, were the "p-values." Those indicate the chances that favorable results might have been by chance, not exactly by the drug being tested. P-values determine "statistical significance." To be statistically valid ("significant") there must be no chance greater than one in twenty that the results were random, not "significant" or actually caused by what it being tested. P values are in the range from 1.0 to 0.0, expressed in hundredths. A p-value of 0.05, the stat-sig cutoff (higher values indicate randomness, not direct effect) is a value of one-in-twenty.
Well, look at the study's p-values: < .0008 and <.0001. Simply, blarcamesine works, profoundly in the majority of those with Alzheimer's. But, as the genomic analyses show, not so well in 12 to 23% of those with the disease. They have genetic variants with reduced responses to blarcamesine.
What does all of this mean? Again, blarcamesine really does provide profound therapeutic outcomes for the majority of those with Alzheimer's. Cognition was actually improved, not just maintained.
But, for a few, at the concentrations used in the study, blarcamesine had reduced or minimal therapeutic outcomes.
There is no doubt in my mind that when the final Alzheimer's/blarcamesine study data appear, they will simply confirm these earlier data. With that, blarcamesine will get regulatory approval for sales and therapeutic use. In this study, the data are clear as day. Significantly improved scores of cognition and daily living, all with statistical significances entirely obviating any chance or otherwise anomalous causes. For most, blarcamesine WORKS for Alzheimer's.
But what about those with unfavorable genetics, the 12 to 22 percent of study participants? For them, two additional studies will be needed. I perceive a really good chance that blarcamesine might be able to prevent the progression of Alzheimer's in those people, if administered prophylactically, before and just at the appearance of symptoms; before the disease has set in and caused it's cellular anomalies; or, those people may need much larger doses.
(Or, later, they will need Anavex 3-71, which very likely has differing underlying genetics.)
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Anavex - Interview med CEO
Anavex Life Sciences CEO discusses trials of new Parkinson's and dementia drugs
Yahoo Finance's Myles Udland talks with Anavex Life Sciences CEO Christopher Missling about the company's new Parkinson's disease drugs as well as its recent capital-raising stock sale.
Yahoo Finance (finance.yahoo.com)
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Anavex - Biogen : Phase 1b Study On Alzheimer's Disease Meets Primary Objective Of Safety & Tolerability
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Tau er en del af Alzheimers problemet. Et protein der ophobes i hjernen.
Data siger ikke nogen om hvorvidt patienten får det bedre.
Kunne være samme historie som Aduhelm. Behandlingen virkede på det man ønskede fjernet, men patienten fik det ikke bedre.
Men få oplysninger så måske dømmer jeg for hårdt.
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ANVS' præsentation af deres biomarker data var absolut IKKE imponerende, selv om man påstår at dataene viser positive forbedringer på alle undersøgte markører. Selve præsentationen var helt sikkert heller ikke særlig heldig, og aktien kan i værste fald blive halveret i dagens handel. Disclaimer har selv en mindre portion. Præsentationen kan ses på nedenstående:
https://irpages2.eqs.com/download/companies/annovis/Presentations/Annovis - AAIC Presentation 7.28.2021 .pdf -
Anavex - nogle interessante data fra Ihub mv
Først fra manden med det umulige navn:
https://piotrpeterblog.com/2021/07/27/how-to-digest-alzheimers-data-from-aaic-2021-avxl-anvs-crtx-sava/Figur a er data fra Anavex fra det 25/32 pts store AD forsøg, der er afsluttet. Figuren er med 21 pts efter 3 år i behandling.
Øverste kurve repræsenterer kun 2 pts med
- SIGMA1 wild type
- APOE gen af typen APOE3
- Høj dosis blarcamesine (50mg)
- MMSE > 20
Det er disse pts der har en umiddelbar, supergod og langvarig respons på blarcamesine - ses visuelt af kurven.
Hurtigt 6 point forbedring i MMSE og altså en forbedring fra inden behandlingen blev iværksat. Passer godt med de videoer vi har set fra Australien, hvor forbedringen udtrykkes som sket umiddelbart.
Interessant ville det være, at vide hvor mange AD pts opfylder disse betingelser.
Missling påstår at SIGMA1 varianten er repræsenteret i ca 90% af populationen (det er ikke præcist om det er i AD populationen eller generelt)
Af APEO genet er der 3 forskellige slags - APEO2, APEO3 og APEO4 - med en forekomst på ca 8.4%, 77.9% og 13.7% (vi har to APEO gener)
Man ved at bærer af APEO4 genet har en øget risiko for AD og at ca 40% af AD patienterne bærer dette gen. Det er oplyst, at homozygotisk (APOE4/APOE4) forekomst giver en 50% risiko for AD.
Så ved lidt regning så kunne blarcamesine i høj dosis virke "supergodt" på 0,9x0,6 eller ca 54% af AD patienterne, hvis behandling iværksættes tidligt - MMSE > 20
Samtidig er der også noget der tyder på, at blot SIGMA1 receptoren er til stede så kan der opnås en virkning - altså kan målgruppen for Anavex være ca 90% af alle AD patienter.
Da ikke alle oplysninger om forsøget er tilgængelige og da beregningerne er sket ud fra et meget lille forsøg er der naturligvis en pæn usikkerhed til tallene omkring størrelsen af målgruppen og superrespondere. Jeg har bl.a. i beregningerne forudsat, at der ikke er AD pts med APEO2-genet i forsøget da man ved, at forekomst af dette gen reducerer risikoen for at få AD.
Missling påstår senest i Yahoo interviewet, at Anavex har videnskabligt bevist sammenhængende med biomarkørerne (SIGMA1, APEO-gen mv) og effekt af blacarmesine på patienterne. Hvilket vil lette behandlingen hos fda.
Hvis Anavex kommer i mål med ca 50% superrespondere i 50 mg gruppen eller blot mindre i AD så er der store kursstigninger forude.
NB
MMSE er en metode til at måle kognitive færdigheder - udtrykkes i et heltal på 0-30 med højeste tal som bedst kognitiv færdighed. -
Anavex - Selv om Anavex stiger i formarkedet så tror jeg nødvendigvis ikke at Annovis's fald vil gavne Anavex.
Hele euforien ovenpå Aduhelms approval skal bæres videre frem af succes i de virksomheder, der er steget på den baggrund.
Men interessant hvad der sker i dag.
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Anavex Life Sciences Announces ANAVEX
2-73 (Blarcamesine) Significantly Prevented Aβ (Abeta)-induced Cognitive Deficits with Confirmed Significant Biomarker-response in Animal Model of Alzheimer's DiseaseAnavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Significantly Prevented Aβ (Abeta)-induced Cognitive Deficits with Confirmed Significant Biomarker-response in Animal Model of Alzheimer’s Disease
Pre-Treatment with ANAVEX®2-73 entirely prevented Abeta-induced cognitive decline Anavex planning a Phase 3 prevention trial of ANAVEX®2-73 including participants at risk for cognitive and functional decline related to Alzheimer's disease NEW YORK, July 29, 2021 (GLOBE NEWSWIRE) -- 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 di
Yahoo Finance (finance.yahoo.com)
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Anavex - Nyhed
Anavex Life Sciences Announces ANAVEX®2-73 (Blarcamesine) Significantly Prevented Aβ (Abeta)-induced Cognitive Deficits with Confirmed Significant Biomarker-response in Animal Model of Alzheimer’s Disease
Pre-Treatment with ANAVEX®2-73 entirely prevented Abeta-induced cognitive decline Anavex planning a Phase 3 prevention trial of ANAVEX®2-73 including participants at risk for cognitive and functional decline related to Alzheimer's disease NEW YORK, July 29, 2021 (GLOBE NEWSWIRE) -- 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 di
Yahoo Finance (finance.yahoo.com)
Planlægger tilsyneladende nyt AD profylaktisk forsøg...
...og så hedder receptoren SIGMAR1 - fejl i mit tidligere indlæg
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No problem Solsen, vi postede på omtrent samme tid så det kunne du ikke vide.
Saa det forsøg er faktisk det Missling snakkede om, en alderdoms pille for at forhindre Alzheimers!!
Fantastisk hvis det lykkes og rigtig god timing af Missling, pre-market voldsomt i vejret for Anavex.
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Anavex. Hilsen fra ferielandet!
Super nyhed fra Anavex - 2-73 som præventiv Alzheimer behandling mm.
Dette er en ny stor milepæl i Anavex historien!
Tænkte at starte en ny tråd på denne nyhed - I kan evt. kopierer jeres indlæg over i denne - hvad synes I??
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