Anavex
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Anavex. Igen et stærkt Tweet fra Anavex!
Denne gang har de undladt " potentiel " - men skriver at 2-73 beskytter hjerneceller mod skadelig stress og opbygning af giftig protein!
Det kan man bare ikke skrive uden videnskabelig evidens!
https://twitter.com/anavexlifesci/status/1364921493243777027?s=21
Statements are getting stronger.
"ANAVEX
2-73 activates the sigma-1 receptor protein, which protects brain cells from harmful stress and toxic protein buildup."Ser ud til, at vi som så ofte tidligere, først ser præsentationen lige før webcastet.
Så bliver webcastet måske desto mere spændende. -
Uden at være engelskkyndig så mener jeg, at når de i tweetet i går skrev reviewet så er der uafhængige inde over påstanden.
De (uafhængige) må nødvendigvis også sige "potentiel" stop PD, idet der skal noget mere evidens på plads inden et endegyldigt svar kan gives.
Den diskussion foregik også på Ihub, men tror ikke der blev boret nok i det engelske.
Anavex må snart komme med noget !
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Anavex Solsen - den Tweet jeg henviser til, er den nye fra i dag, som kun er en time gammel.
Den med "potentiel" var den fra sidste dag.I denne Tweet er der ingen "potentiel", men en faktuel påstand, som må bunde i verificeret videnskabelig forskning.
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Ja spændingen er næsen ulidelig og håber da at der kommer noget med kød på i dag men det er ikke sikkert.
Er er lige et link om hvordan den meget uhyggelige sygdom Alzheimer's udvikler sig.
Folk kan leve imellem 3 -11 år after at værre blevet diagnostiseret med sygdommen men nogle har levet i 20 år før der er forbi. Meget trist læsning, men lidt trøst at Anavex måske kan hjælpe ca 80% af tilfældene om måske 3 års tid og dem der får 2-73 tidligt i stadiet kan sikket leve et normalt liv indtil andre aldersbetingede sygdomme gør en ende på det. -
Kyed01 ... ja det er vildt, hvis 2-73 kan hjælpe, som der tweetes.
Som en meget rigtigt skriver på Ihub. Så kan man godkende RNA vacciner og give mio af mennesker.
Hvis de forsøg mv vi har set bliver undersøgt grundig er det svært at forstå, at man ikke kommer i gang med 2-73 snarest.
Man kunne jo følge en stor gruppe pts i et åbent fase 4 forsøg og stoppe behandling, hvis der opstår problemer ?
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Er det udelukkende disse 3 forsøg man skal holde øje med?
Og er det alle de kliniske forsøg der kører for tiden?
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Anavex Webcast kl. 18.00 link.
Anavex Life Sciences to Present at the 10th Annual SVB Leerink Global Healthcare Conference on February 25, 2021
NEW YORK, Feb. 18, 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 disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, has been invited to present at the 10th Annual SVB Leerink Global Healthcare Conference. Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, is scheduled to present on Thursday, February 25th, 2021 at 12:00 p.m. EST and will discuss the Company's progress and outlook. The presentation will be webcast live and available for replay here and via the investor relations section of the Company’s website at www.anavex.com. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of 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, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease and a Phase 2 proof-of-concept study in Parkinson’s disease dementia and a Phase 2 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information: Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: [email protected] Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: [email protected]
Yahoo Finance (finance.yahoo.com)
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Imponerende CC
Missling fejede Acandia af vejen i Rett. Meget dårligere effekt og dårlig mave (AE). Vel eneste konkurrent lige nu på Rett.
Mange fakta som jeg ikke fik noteret ned.
Men et interessant år forude med snarlige fulde datasæt på Rett og PDD offentliggjort og Avatarstudiet.
Bør høres !
Jeg er overbevist
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Anavex Udmærket CC!
Missling er ikke i tvivl om at 2-73 virker - også langt bedre end evt. konkurrenternes tilgang. - i samtlige indikation de har gang i!
Han nævnte f.eks at man i patienter fra ekstension forsøgene i RETT havde set ekstrem signifikant kliniske resultater - endda på lav dosis! - og at man derfor kunne forvente endnu bedre resultater i + 18 år med høj dosis - og endda endnu bedre resultater i 5-18 års forsøget.- og ingen bivirkninger overhovedet!
Nævnte, at bare det, at man overhovedet så en effekt i de ældre RETT piger i sig selv var uhørt - at effekten tilmed så signifikant, var helt ekstrem!
Vedr. resultaterne Parkinson forsøget, så var dette forsøg også et "prof of concept" for deres Alzheimer fase 3 forsøg - så man derfor her også, med stor sandsynlighed, kunne forvente et positivt resultat!
Missling virkede meget selvsikker og klar i sproget - alt ser rigtig godt ud!
Vi må bare væbne os med tålmodighed!
- og ingen bivirkninger overhovedet!
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Præcis, vi havde nok set +20% hvis ikke market genrelt var rødt. Nå men fing Vestas og anavex er da i plus for dagen....
jeg har valg dobbelt op, på mit swing... tænker at jeg snildt kan få 16-17$ og lander der nyheder, der giver kursen benzin, så holder jeg indtil nok er nok -
Anavex Link til webcast.
Alle input fra dem - der har set og hørt webcastet er værdsat!
Der var ikke meget nyt i selve de viste sider, men det var i høj grad det der blev sagt, man skulle tage notits af.
Ja Anavex har godt nok ikke været heldig med medvind fra markedet - trods det klare den sig dog ok - indtil nu:) -
Link til CC
https://wsw.com/webcast/svbleerink47/avxl/2676736De nævnte $277bn er blot Alzheimers.
Det kan gå helt amok mht kursen, hvis det vi tror holder.
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Har lige hørt det forsinket. Jeg bed mærke i at det er 80-90 % der har gavn af produktet. Vildt. Og så er jeg lidt forvirret over at han nævnte systisk fibrose ifm snakken om Rett - er de i gang på området med systisk fibrose også? - eller var det bare en sammenligning til at man også "fødes" med den sygdom?
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Missling nævnte cystrisk fibrose som en arvelig sygdom men kunne planlægge sig ud af.....
Mens Rett ikke er arvelig, men en tilfældig mutation på x-komosomet, hvor drengebørn dør mens piger overlever men deres tilværelse er voldsomt hæmmet af sygdommen.
Så ikke noget fra Anavex til cystisk fibrose.
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Anavex. Sammendrag fra webcast.
Kunne især godt lide den måde Missling understregede, hvor signifikant resultaterne fra fase 2 PDD var:
"Patienter med demens, der startede forsøget på høj dosis 2-73, var mindre demente efter 14 uger i forsøget!"
Det er da helt vildt i en indikation, som man hidtil ikke engang har kunnet bremse udviklingen af sygdomsforløbet i!!!
Lånt fra IHUB:
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 continue as planned.
Tillægs DD:
Vedr. konsortie forsøget i:
Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
Har store Novartis ( MC 196 milliarder $ ) efter opkøb af Cadent, overtaget dennes plads i konsortiet.
Det er altså nogle voldsomme store spillere Anavex sidder til bords med i dette fælles projekt!
Cadent Therapeutics - nu Novartis
Alkermes, Inc.
Anavex Life Sciences Corp.
Merck Sharp & Dohme Corp.
Takeda
Sage Therapeutics
H. Lundbeck A/S
Astellas Pharma Inc
Apex Innovative Sciences
Columbia University
COGNISIONMisslings gennemgang af markedspotentiale i RETT i webcastet, indikerede dog, at de er overbevist om at RETT snart kommer på markedet og at dette i sig selv vil give Anavex tilstrækkelig store muskler til at kunne beholde guldet selv i de andre indikationer også!
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