ANAVEX. NY TRÅD NY TRÅD over 100 % indrulning i Alzheimer!
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Anavex. Indrulning i Alzheimer fase 2/3 forsøget - ikke afsluttet.
En detalje!
Iflg. indlæg på IHUB, har enkelte talt med IR hos Anavex, for at få bekræftet, at fase 2/3 forsøget er færdig indrullet.
I PR.en står der jo kun, at man nu har indrullet flere end de nødvendige 450 patienter og ikke at man har stoppet optagelsen af nye patienter.
IR har angivelig bekræftet, at indrulningen ikke er stoppet og at der forsat står patienter i kø for optagelse.
( Det jo en 14 dages testningsprocedure om man er egnet til forsøget, inden man evt. bliver indrullet )Dvs. at nedtællingsurret reelt endnu ikke er startet på de 48 uger!
For at sikre bedst mulig grundlag for et signifikant resultat, ville det være meget fornuftig, at polstre forsøget med flest mulige patienter - måske + 500-600 og samtidig få sikret et vist antal patienter på samtlige af de 52 aktive sites, så alle sites potentielt kan have nogle superresponder iblandt. ( Flere forsker/læger ville så med egne øjne kunne se effekten i deres patienter )
Anavex får aldrig bedre mulighed end nu til at få flest mulige patienter indrullet - senere kan Biogen effekten jo måske ødelægge optagelsen i nye forsøg generelt.Vi kan derfor nok forvente endnu en PR omkring afslutning af indrulningen og en reel start af nedtællingsuret.
Det vi nu har set fra Biogen og FDA, tydeliggøre nødvendigheden af den strategi Anavex har kørt, med forsøg kørt udenfor US og den grundige sikring af patenter og underbyggende forskning, således at man som et lille Biotek selskab har bare en lille chance i en biotekverden, hvor det meste i sidste ende bestemmes af penge og indflydelse!!!
Dette vi ser nu og den næste tid vil være et historisk vendepunkt i CNS forskningen - og vi stå midt i dette som investorer!
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Anavex. Videnskabelig underbygning MOA af både 2-73 og 3-71!
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Højde punkter (fra min e-mail inbox):
Scientific Paper Highlights:
• Sigma-1 receptor (SIGMAR1)'s expression increases with age, however in Alzheimer's disease (AD) it decreases
• The decrease in SIGMAR1 expression during AD coincides with an age-related decrease in autophagy
• The SIGMAR1 may compensate for loss of receptors and autophagic machinery during healthy aging
• SIGMAR1 is activated by ANAVEX-compounds
• ANAVEX
2-73 has been shown to induce autophagy
• Activation of the SIGMAR1 can induce cytoprotective autophagic pathways -
NEW YORK - June 14, 2021 - 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 reported that ANAVEX
2-73 (blarcamesine) and ANAVEX3-71 (AF710B) are featured in a new peer-reviewed publication in the journal of Expert Opinion on Therapeutic Targets, titled "The emerging role of the sigma-1 receptor in autophagy: Hand-in-hand targets for the treatment of Alzheimer's". [1]Scientific Paper Highlights:
• Sigma-1 receptor (SIGMAR1)'s expression increases with age, however in Alzheimer's disease (AD) it decreases
• The decrease in SIGMAR1 expression during AD coincides with an age-related decrease in autophagy
• The SIGMAR1 may compensate for loss of receptors and autophagic machinery during healthy aging
• SIGMAR1 is activated by ANAVEX-compounds
• ANAVEX2-73 has been shown to induce autophagy
• Activation of the SIGMAR1 can induce cytoprotective autophagic pathwaysThe authors of the paper point out that studies using positron emission tomography (PET) have shown that in healthy aging, there is no loss of the SIGMAR1; in fact, there is a possible increase in SIGMAR1 expression [2] that coincides with the age-related loss of the M1/M4 muscarinic receptors [3], D1/D2 dopamine receptors [4], and serotonin (5HT2A) receptors [5]. The increase in SIGMAR1 expression may be a compensatory mechanism for the loss of the other receptors [6].
However, PET scans of patients with a recent AD diagnosis show a reduction of SIGMAR1 expression [7]. SIGMAR1 also promotes autophagy and results in the degradation of amyloid-beta precursor protein (APP) thereby inhibiting Aβ production [8].
The publication explains that AD is a multifactorial disease, where several pathways interlink with each other and cause cognitive impairments. The available drugs only tend to target a single pathway and mitigate the symptoms of AD without slowing the disease progression. Combinatorial therapy has been suggested as a treatment strategy; however, the existence of drug-drug interaction is a concern. Hence, there is a need for the development of drug molecules that can target multiple pathways to halt disease progression and improve the memory function.
SIGMAR1 has emerged as one of the prominent targets in treating neurodegeneration. It is involved in the modulation of glutamate levels, maintaining endoplasmic reticulum (ER) function, and calcium regulation, promoting neurogenesis, reducing reactive oxygen species (ROS) formation, suppressing neuroinflammation and ameliorating Aβ toxicity [9] . Recent studies with ANAVEX
2-73 show that SIGMAR1 activation is also involved in autophagy, an intricate phenomenon that clears damaged cellular organelles and misfolded proteins [10]. SIGMAR1 agonists, including ANAVEX2-73 and ANAVEX3-71 have been reported to block toxic Aβ, tau and neuroinflammation [11].Autophagy and the cellular machinery involved are essential to homeostasis and cell survival. Autophagy has been shown to be important for axonal health and homeostasis as autophagy inhibition leads to axonal wasting [12].
During the early stages of AD, it has been noted that there is an accumulation of Aβ and tau protein in the dystrophic or swollen neurites of AD patients' brains. Furthermore, it is well known that autophagy plays a key role in the management of Aβ and tau protein levels, and that some of the key proteins involved in the autophagy mechanism disappear with age, resulting in decreased autophagy in older brains [13]. At the same time the SIGMAR1 is upregulated, possibly compensating for the reduction in autophagy, and reduction in other receptors, such as muscarinic receptors [14], dopamine receptors [15], and serotonin receptors[16], in an attempt to protect the neuron cells.
Since it has been observed that a number of SIGMAR1 agonists, including ANAVEX
2-73, is able to upregulate SIGMAR1 expression in the brain, it is possible that these drugs could help the cells to compensate for the loss of other receptors and autophagy machinery.The authors conclude, that in the future it may be the case that SIGMAR1 ligands (or drug combinations) targeting the activation of autophagy, and other SIGMAR1 related neuroprotective pathways, are prescribed prophylactically, in much the same way as with statins for the prevention of heart disease today in an effort to prevent the loss of the SIGMAR1 receptor seen during AD.
"This independent paper highlights the understanding of the relevance of utilizing sigma-1 receptor activation as compensatory mechanism to chronic CNS diseases, currently tested in late-stage placebo-controlled ANAVEX
2-73 Phase 2b/3 clinical Alzheimer's disease study, which recently completed enrollment, as well as in Parkinson's disease dementia (ANAVEX2-73-PDD-001) and ongoing Rett syndrome program (ANAVEX2-73-RS-001/002/003)", said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.ANAVEX
2-73 activates the sigma-1 receptor (SIGMAR1). Data suggests that activation of SIGMAR1 results in the restoration of complete housekeeping function within the body and is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. [17]Anavex Life Sciences' product portfolio platform includes small molecule drug lead candidate ANAVEX
2-73 for the treatment of Alzheimer's disease, Parkinson's disease and Rett syndrome and ANAVEX3-71 for frontotemporal dementia. -
Jonestrading AVXL nyt pris mål: 35$
Anavex Life Sciences (AVXL) Stock Forecast and Price Target 2026 $AVXL
AVXL's current price target is $21.33. Learn why top analysts are making this stock forecast for Anavex Life Sciences at MarketBeat.
(www.marketbeat.com)
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Anavex Denne Peer Review er blot en 3. parts verificering af, hvad Anavex har forsøgt at fortælle omverden i efterhånden flere år nu.
Der står ikke noget vi ikke har hørt tidligere.
Fin der også er beskrevet at 2-73 understøtter cellernes evne til at rense sig selv/regenerer ( autophagy ) - hvilket nok er det vi kommer tættest "den hellige gral" - hvilket rækker langt udover Alzheimer og kan være til gavn for ,i princippet, alle mennesker på et tidspunkt i livet.Det sjove er bare, at dette kun er en lille forsmag på det vi venter på fra Anavex i denne måned.
Anavex har stadig 3-4 Pr.`s udestående de næste par uger.
Anavex bliver mere og mere synlig for flere og flere!
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Jeg håber virkelig at FDA's Billy Dunn fik morgen kaffen galt i halsen da han forhåbentlig læste den peer revived publikation. Det burde gøre ham meget nervøs da FDA i deres arrogance har troet på den forkerte fremgangs måde at behandle Alz. De har en mentalitet: Vi ved bedst!!
Super dejligt at se kurs ca 19 i dag og 4 mill i volumen før kl 12 EST
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Skulle jeg komme med et gæt/ønske så tror jeg, at når peer review artiklen om PDD forsøget bliver kendt så vil et partnerskab nærme sig.
PDD data virker virkelig lovende. Så derfor tror jeg, at der kommer en partner ind med et pænt kapitalindskud - ejerandelen tør jeg ikke gætte på.
Partneren skal være med til fda møderne omkring studiets udformning - måske uden Anavex, hvis de får licens på denne indikation.
Anavex tager selv salget i de små "orphan" indikationer.
Spændende tid de kommende måneder eller mindre
NB Endnu en gang tak til Tasso1 !
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Anavex. Kursmål?
Biogen fik tillagt en merværdi på ca. 25 milliarder $ ved godkendelsen af ADU alene i Alzheimer.
Dette ville betyde kurs 375 $ for Anavex ved tilsvarende godkendelse.Får vi nu som ventet resultater fra PDD med 70 % sammenfald af endpoints med Alzheimer, som kraftig indikere, at man ville få tilsvarende gode resultater i deres fase 2/3 i AD, med sandsynlighed for en markedsgodkendelse i 2022 - så skal kursen op i 100-150 $ inden da.
Og dette er kun for 2-73 alene i AD!
Tillæg de andre indikationer med 2-73,3-71 og 1066!Når dette er sagt, er det aldrig forkert at tage en gevinst undervejs!
Biotek er biotek - og man kan altid reinvesterer eller udnytte andre muligheder der altid måtte opstå.Men ja - det har været en lang og ujævn tur hertil efter nu + 6 år, med ufattelig mange timer med studering og analyse af div. udgivelser og indlæg.
Man har ofte skulle have is i maven og stole på den viden man havde indhentet, uden at skele til kursen.Langt om længe synes Anavex, at kunne begynde at få bragt deres budskab og videnskab frem i lyset.
Der er et stykke vej endnu, men denne gang tror jeg at tiden og tidspunktet er helt rigtigt.
Tak for en rigtig god sparring i tråden hidtil! -
Anavex Enormt håb for Anavexs Alzheimer pipeline!!!
Research published in a medical journal provides enormous hope for the company's pipeline Alzheimer's drug.
Why Anavex Life Sciences Stock Soared 35% Today | The Motley Fool
Research published in a medical journal provides enormous hope for the company's pipeline Alzheimer's drug.
The Motley Fool (www.fool.com)
Man kan have delte meninger om The Motley Fool, men de har en relativ stor følgerskare - så en positiv omtale her, kan puste til forsat momentum i Anavex!
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Det havde ellers været hyggeligt med 14 dage i streg med grønne stager.....
GAPet kan godt springes over, hvis nyhederne kommer i en jævn strøm/ (sjældent dog) de plejer at lukkes. Lidt øv at en volume på 16 mil trak den op med 30% men kun 2 mil kan få den ned med 15% daytradere hygger sig.....
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easy comes - easy goes, føles lidt som d. 6/11-20.
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