Anavex HISTORISKE OG BANEBRYDENDE RESULTATER I ALZHEIMER!!!
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Jeg fik ikke meget reaktion på SAVA, men er der nogen der har indblik i denne eller er det den "gammeldags" amyloid tilgang?
Kunne jo være "tyskerne" taler sammen.
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Der er godt nok meget der foregår på dette område.
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Is Anavex Life Sciences a Buy?
13/12 15:45
As a pre-revenue biotech company that's approaching decisive clinical and regulatory milestones, Anavex Life Sciences (NASDAQ: AVXL) isn't an investment for the faint of heart. It has no products on the market, and its share price is, for now, entirely dependent on how much the r...
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Anavex Motley Fool er altid været negativ på Anavex gennem alle årene.
Den lødige og efter mening største direkte fjendtlige skribent, Adam Feustein har tidligere været ansat hos Motley Fool.
MF har dog forsat de negative skriverier mod Anavex og hylder f.eks. Biogen.
At de har et par positive linjer skrevet i denne artikel, ændre ikke ved, at de forsøger at skræmme investorerne væk. -
Vil vi opleve tilsvarende sagsanlæg fra Anavex som SAVA meddelte tilbage i starten af november? Det kunne være rart. Det har vel været med til at sætte en midlertidig stopking for en del af shorterne i SAVA og været med til den positive kursudviklngen.
AUSTIN, Texas, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company, today announced that it has filed a lawsuit in federal court against certain individuals who executed a "short and distort" campaign against the Company. The 150+ page complaint alleges that the Defendants' disinformation campaign caused a precipitous decline in Cassava Sciences' stock price, a multi-billion dollar decline in its market capitalization, and delayed the Company's work in developing a treatment for Alzheimer's disease.
The lawsuit alleges: "Defendants placed personal enrichment over science, over the health of patients, and over the truth. Defendants saw an opportunity to manipulate a stock price and financially benefit from their 'short positions' by defaming a company developing a drug for people with Alzheimer's disease, a condition that afflicts millions of people. Defendants seized that opportunity and, while enriching themselves, caused irreparable harm to the company, its attempts to find a treatment for the disease, and patients waiting for that treatment. Defendants' conduct is beyond shameful. It is unlawful."
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Anavex styrker advisory board:
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Lige et citat fra pr på Grimmers optagelse i boarded:
"I'm excited to join Anavex's Scientific Advisory Board at this time of important growth and evolution of the Company," said Professor Dr. Grimmer. "There is such a significant unmet medical need around the globe caused by Alzheimer's disease and patients in the Phase 2b/3 ANAVEX
2-73-AD-004 study performed better even after a year despite the progression of this devastating disease. It would be groundbreaking for patients and their loved ones if healthcare professionals are able to provide a therapeutic which can be taken orally and is generally safe, which the study indicates, ANAVEX2-73 (blarcamesine) is a likely candidate."Han deltog på seneste cc fra Anavex og var investigator på det nyligt rapporterede fase 2b/3 i AD. Har tidligere deltaget i mange men monoklonare antistoffer imod ophobning af amylin i hjernen.
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Anavex Endnu en der har oplevet effekten af 2-73 på nærmeste hold og ønsker at være med på rejsen og gøre en reel forskel!
Enten det - eller han bare har sagt ja pga. ussel mammon og med usande udsagn om at AD patienter faktisk bliver bedre?
Og måske har shorterne ret, at Anavex har pustet deres data op ved udspekulerede fejlberegninger og generel uærlighed omkring deres videnskab.Det må være helt op til den enkelte at bedømme!
Tror dog stadig naivt på, at der er forsker, læger og selskaber, der først og fremmest ønsker det bedste for disse reel ubehandlede indikationer og brænder for at kunne gøre en reel forskel!
Som jeg tidligere har skrevet, så vil vi få et gennembrud også i Alzheimer på et tidspunkt.
Måske skal et sådan gennembrud komme fra nogle, som er innovative og ikke fastlåst af traditionelle måder tilgå tingene og som samtidig ikke har afkastet til sig selv og aktionærerne som første og måske eneste prioritet.
Anavex er indbegrebet af et sådan selskab og alt tyder på, at de har fat den helt rigtige ende på CNS området. -
Anavex Positive Lane Simonian fra Seeking Alpha.
Anavex Life Sciences: The Little Company That Did
Dec. 06, 2022 12:51 PM ETAnavex Life Sciences Corp. (AVXL)BIIB, ESALF, ESALY268 Comments
Lane Simonian profile picture
Lane Simonian
2.24K Followers
SummaryAnavex's 2-73/blarcamesine produced significant reductions in cognitive decline in early Alzheimer's disease as measured by ADAS-Cog and CDR-SB scores.
Those who had improvements in cognition did so by an average ADAS-Cog score of 4 points, which is considered to be clinically significant.
In an earlier phase 2a trial, most (4 out of 6) high concentration patients improved, whereas no medium concentration patients improved.
The high dose group patients in the phase 2b/3 clinical trial are likely to do considerably better than the pooled 30mg and 50mg group.
It is very difficult to gauge how the FDA will decide on blarcamesine; such a decision will be critical to Anavex's stock value.Sporty man on the mountain peak looking on mountain valley with sunbeams at colorful sunset in autumn in Europe. Landscape with traveler, foggy hills, forest in fall, amazing sky and sunlight in fall
den-belitsky/iStock via Getty Images
Anavex Life Sciences Corp. (NASDAQ:AVXL) presented the results from its phase 2b/3 clinical 48-week trial for Anavex 2-73/blarcamesine at the CTAD conference on December 1st (revised presentation). Blarcamesine met its primary and secondary endpoints by significantly reducing cognitive decline as measured by ADAS-Cog and CDR-SB, respectively. Anavex stated that it met its other primary endpoint: reduction in decline in activities of daily living as measured by ADCS-ADL, although it has not provided specific data to support this as of yet (press release). Up to this point, Anavex has provided results from the combined 30mg and 50mg dose groups. However, once separate data is provided for the 50mg group, blarcamesine is likely to be the first Alzheimer's drug or drug candidate to produce a mean improvement in ADAS-Cog scores at 48 weeks.
One might have expected a greater increase in stock value based on the initial announcement of results. Critics, though, succeeded in creating a lot of noise surrounding Anavex's presentation (and subsequent conference call), teed up in part because the company had not yet completed all the analysis. In the end, though, the one legitimate concern is how will the FDA view the trial. Until that decision is reached, Anavex and its stockholders will be left in a kind of limbo.
Going by the NumbersOn average, those on blarcamesine declined by 45 percent less in cognition as measured ADAS-Cog scores and 27 percent less in cognition as measured by CDR-SB scores than those on placebo. Patients who improved on blarcamesine did so by an average of -4.03 points (a smaller score on ADAS-Cog represents an improvement in cognition). Those who improved by at least -.5 points in ADAS-Cog scores on blarcamesine were 84 percent more likely to do so than those on placebo and 167 percent more likely to improve by a clinically significant 3.5 points on ADCS-ADL scores. Since around 65 percent in both groups were on Alzheimer's medications, this is one indirect indication that blarcamesine is more effective than the standard of care. Previous data helps to confirm this. At six months, 20 percent of patients on Aricept improved by an ADAS-Cog score by 4 points or more, in Anavex's phase 2a trial 33 percent of patients in the medium and high concentration groups (4 out of 12 at 57 weeks) improved by an ADAS-cog score of 4 points or more, and 66 percent in the high concentration group (four out of six) improved by an ADAS-Cog score of 4 points or more (Anavex used MMSE scores in the phase 2a trial; a one-point change in MMSE scores equates to about a two-point change in ADAS-Cog scores) (charts on pp. 23, 29). At 57 weeks, the high concentration group improved by a mean 2 MMSE points, at 70 weeks they improved by a mean of 3 MMSE points, and at 148 weeks they declined by a mean of around 1 MMSE point.
Some points of note regarding this. No one in the medium concentration group improved at 57 weeks, so pooling medium and high dose numbers in the phase 2b/3 trial likely diluted the drug's effects. On the other hand, excluding sigma-1 receptor variants from treatment effects in the larger trial improved results. If around half the population with early Alzheimer's disease improves cognitively at around a year, and they remained nearly stable for three years, that marks a major breakthrough in the treatment of early Alzheimer's disease.
In regards to safety, Anavex has stated that most of the side effects have been either mild or moderate, with dizziness and confused state being the most common. These side effects led to 17 dropouts out of 37 in total in the drug group (out of 338 participants). In the conference call, Anavex largely did not address the severity or timing of these side effects. The company suggested that the problem of dizziness was usually mild and might be avoided by taking the drug before bedtime. For confusion, this was at least sometimes resolved by down-titration of the drug. More details are needed on whether anyone else dropped out of the trial due to rare side effects (whether related or unrelated to the drug) and what those side effects were.
What seems abundantly clear, though, is that no one died from blarcamesine, and unlike most anti-amyloid drugs there were no problems with brain swelling or brain bleeds. The great irony behind Eisai Co., Ltd. (OTCPK:ESALY) and Biogen's (BIIB) drugs is that they only slow the progression of the disease in APOE4 carriers, but these are the patients most likely to have severe and even fatal reactions to the drug (Ban2401/lecanemab: table 16, aducanumab: p. 58/12). Blarcamesine is both far safer than most anti-amyloid drugs and much more effective, at least at the highest dose.
Going by the ScienceBlarcamesine is a sigma-1 receptor agonist. Sigma-1 receptor agonists inhibit the release of intracellular calcium into the cytosol. This limits oxidative stress, nitrosative stress, neuroinflammation, and mitochondrial dysfunction in early Alzheimer's disease and likely in a number of other neurological diseases and conditions.
Neurotoxicity
Pathways in Neurological Diseases (Frontiers in Cellular Neuroscience)
As Alzheimer's progresses, calcium influx rather than calcium release from the endoplasmic reticulum becomes the major problem. To a certain extent, sigma-1 receptors may limit calcium influx. Blarcamesine, a tetrahydrofuran derivative, potentially is also a peroxynitrite scavenger (ONOO-), which may at least partially explain why it is more effective than the sigma-1 receptor agonist Aricept at the highest dose. But as the disease progresses, some of the enzymes and receptor types on the right side of the chart are damaged by oxidation and nitration (g protein-coupled receptors and protein kinase C, for instance), so the primary function of sigma-1 receptor agonists in terms of treating Alzheimer's disease is lost.
Anavex's next clinical trial results will be for pediatric Rett syndrome, which is part of the autism spectrum disorder. Many of the same routes as displayed in the chart above lead to Rett syndrome. Especially for pediatric Rett's, then, one should expect good results from Anavex. Beyond that, the severity of the disease state may in part determine when blarcamesine could best help in the treatment of a variety of neurological diseases and conditions.
What Will the FDA Do?The FDA does consider the results of clinical trials run outside of the United States if meeting certain criteria, and it may accept results from clinical trials with as low as 300 participants (Anavex is cutting it very close if you remove the 30mg group). Whether it will do so in the case of blarcamesine is very difficult to predict. The out route for them would be to approve the drug which would be the best currently available treatment of Alzheimer's disease but require further confirmatory trials. Separate from this, regulatory agencies in other countries such as Australia and Canada, potentially could grant approval to blarcamesine, with or without additional confirmatory trials.
Challenges and OutlookAnavex would face some difficult decisions if it needs to run another phase 3 clinical trial without the ability to sell blarcamesine. The company still has $149.2 million cash or cash equivalents on hand, which would be enough to run another phase 3 clinical trial for Alzheimer's disease (financial information). There is a potential for a partnership of some kind, but big pharmaceutical companies in the Alzheimer's field have either given up on finding a treatment altogether or keep plowing ahead with anti-amyloid treatments.
In the short term, the best thing the company could do would be to release the data for the 50mg group. This may take time, as several participants were either titrated up or more often titrated down during the course of the trial to address tolerability issues. That is why the 30mg and 50mg groups were pooled. In the meantime, Anavex could give the number of participants who improved on either dose, but if almost no one improved on the low dose and 100 people on the high dose improved, the pooled number does not look very impressive. The risk for investors in the long-term is not so much the initial criticisms, some of which have already been refuted by the company (such as the math "error") or by the results themselves, but if the data is convincing enough for the FDA to grant some form of approval. Anavex keeps repeating that phase 2b/3 results are consistent with phase 2a results and that further data will be even better. They, I believe, are right on both points. So the FDA's decision really comes down to the points I discussed above (size of the trial and no U.S. sites).
It has taken seven years for Anavex to get to this point, with a very methodical and low-profile CEO in Christopher Missling, a small dedicated team, and very loyal investors. Certainly, there have been some missteps along the way, but Missling has delivered a drug that can lead to improvement in some early Alzheimer's disease patients and which may help to treat at least a few other neurological diseases and conditions as well.
So far, the AVXL news has not been widely embraced in a field that has been for years dominated by the amyloid hypothesis for Alzheimer's disease, but for some, at least, that could change once the current data is objectively reviewed and additional results are released. The temporary pullback in Anavex Life Sciences Corp. stock value may be reversed soon, if either or both of these occur. A positive FDA decision, though, would be the game changer.
This article was written by
Lane Simonian profile picture
Lane Simonian
2.24K Followers
Retired history instructor. Alzheimer's disease researcher for the past decade.My goal is to give investors solid advice based on the mechanisms of action of Alzheimer's drugs. This advice is informed by a background in biology (conservation, ecology, evolution, environmental science, and biochemistry) and seventeen years of a very in depth review of the research on Alzheimer's disease.
Show moreDisclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
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Anavex Alzheimer's Association nævner ikke Anavex efter CTAD?
Alzheimer's Association, der skulle forstille at være en organisation, der varetager AD patienternes interesser, nævner slet ikke Anavex i deres referat/konklusion for CTAD.
De hylder dog Biogens Levcamemab, som en meget mulig løsning for Alzheimer.Alzheimer's Association lever hovedsaglig af sponsorater, heriblandt fra BP - på ca. 480 mill. $ årligt.
Top 3 lønninger i Alzheimer's Association:
1 Harry Johns $1,015,015
2 Richard Hovland $650,856
3 Robert Egge $574,617Til sammenligning får Missling 500.000 $!
Kunne der måske være en "lille" sammenhæng mellem de selskaber de fremhæver og hvor de får pengene fra?
Det er nok helt utænkeligt - især i US!
Er bare glad for, at Anavex har kørt forsøgene unden for US og ikke er afhængig af FDA og US systemet!Andel shortede aktier steg fra ca. 10 mill. til ca. 12 mill. den 30. November 2022 - altså umiddelbar før CTAD!
Ikke så sært, at kursen skulle presses ned - uanset resultaterne fra Anavex den 1. Dec!JP Morgan deltagelsen, kan have været signalet til shorterne, at de nu skal begynde at trække sig ud.
Anavex stiller ikke op på JP Morgan uden de er 100 % klar med hele datapakken.
De næste uger med flere nyheder fra Anavex, vil måske presse shorterne yderligere. -
Det viser jo blot, at vi skal forberede os på knaster i det fremtidige forløb.
Mange teorier om hvordan Anavex skal at komme gennem skjoldet i fda. Det bliver en vanskelig opgave.
Jeg håber, at de to tidligere fda ansatte hos Anavex kan åbne nogle døre.
Fda er heldigvis på hælene mht alzheimers og deres skandaløse godkendelse af Aduhelm. Mon ikke Lecanumab ligner Aduhelm så meget, at fortiden skræmmer fda fra at lave to fejl på stribe.
Håber at Anavex kan få 50 mg armen i hus snart. Det er den der skal være sømmet, der gør, at fda ikke kan undslå sig.
Anavex bør i min optik ikke vente for længe med at indgå partnerskab. Deres tempo alene kan godt bekymre.
Siger fda flere fase 3 skal de også have partner på ellers er der mange år til at indikationen er i hus.
Et stort US pharma (partner) der sender ansøgningen til fda tror jeg ville øge odds for at det glider gennem systemet.
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Unmet medical need delen bør virkelig skubbe fremad hos relevante myndigheder. Data kan jo ikke bare sande til hele tiden, hvis det ene eller det andet hele tiden obstruere for fremskridt!
Skidtet er tilsyneladende helt og aldeles ufarligt; Tjek ud for det. Så man kan rent faktisk tilbyde det uden at man bliver dødlige syg af det, (modsat konkurrenternes). FDA nævner selv i deres guidlines, (frit fra hukommelsen), at Unmet er et særligt fokus område fremover, og derfor vil barren også væren en anden, (læs lavere, for at få sat skub i forskningen). Spørgsmålet er ikke så meget godkendelses delen, spørgsmålet er, om fagpersoner herunder nøglepersoner rundt omkring på kloden vil anbefale deres respektive sundheds sytemer og patienterne et stof! Her taler foreløbige data for sig selv.
De efterfølgende peer reviews i de videnskablige litteratur tidsskrifter, vil formentlig gør det helt klart hvad vi taler om. Husk det allervigtigste, udover, progression af lidelsen, er bivirkningsprofilen..
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Pharma- og biotekopdatering uge 50:
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Anavex Nyansatte Timo Grimmer og 3 andre Podcast med CTAD.
En tyske podcast med 4 tyske professorer, heriblandt Timo Grimmer diskuterer den afsluttede CTAD konference.
Dvs. i de ca. 24 min. podcastet vare, så bruger de godt 21 min. alene på Biogen og Lecanemab. Her er de umiddelbar positiv over for resultaterne - de diskuterer dog de 2 dødsfald og nødvendigheden for monitering af patienter og måske en begrænsning til hvilke patienter, der kan få Lecanemab. Men især den ene så frem til at det kom på markedet på et tidspunkt. Der blev også diskuteret, om de forventede måske 6 mdr. Lecanemab evt. kan forlænge sygdomsforløbet, står mål med de økonomiske omkostninger og de menneskelig omkostninger ved selve behandlingsmetoden og skanninger.ENSTE andet selskab der nævnes og omtales positivt er Anavex, hvor Timo Grimmer igen fortæller, at 2-73 har en rigtig god bivirkningsprofil og at patienterne bliver mindre demente i løbet af de 48 uger - samtidig bemærkes der også, at medicinering via tabletform er at foretrække ifht. Biogens intravenøse behandling og løbende skanning af hjernen.
Det undrer mig dog, at de andre professorer ikke havde noget at sige til (læs - faldt på halen over), at patienterne modsat hos Biogen blev bedre?
Der var ikke nogen "løftet øjenbryn" over, at AD patienterne blev bedre - i stedet for blev der igen snakket om Biogen og muligheden for at få Lecanemab på markedet i Europa?
Jeg tænkte bare - MANDEN SAGDE LIGE AT PATIENTERNE BLEV BEDRE OG UDEN BIVIRKNINGER, OG I NÆSTE SÆTNING SÅ SNAKKEDE DE GUDHJÆLPENE OM AT FÅ LECANEMAB PÅ MARKEDET! - HALLO ER DER NOGEN HJEMME???Timo Grimmer er jo efterfølgende blevet ansat af Anavex (som 5. eller 6. tysker i teamet) og alt andet lige, så er det positivt, at Anavex som de eneste udover Biogen klarede at blive omtalt på denne ROCHE podcast.
Meget interessant at man lige i ROCHE regi omtaler Anavex, da de jo lige har stoppet deres fedtfjernelsesprogram i AD og nu siger at de forsat ønsker at være aktiv i Alzheimer, men nu via. en partner, som har anden forskning/platform i Alzheimer! -
Anavex-Når resultaterne , som Anavex har opnået med 2-73, er så gode som div. forskere og professorer inden for området giver udtryk for, burde Anavex så ikke gå mere aggressiv ud i diverse medier for at formidle denne viden ud til almindelige borgere ?! Organisationer som burde varetage syge borgers interesse, samt FDA,hænger øjensynligt da noget i bremsen
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Anavex otul - forventer også at Anavex bliver mere aktive med at få budskabet ud, når de har færdigbehandlet de samlede data og gjort dem mere entydige og sværere at modargumenterer af markedet og især af dem, som har stor interesse i, at Anavex ikke får succes.
40 min. grundig gennemgang på JP Morgan den 12. Januar 2023, kan blive startskuddet til at få banket de gode resultater ind i omgivelserne.
Anavex er helt klar over, at enhver usikkerhed eller tvivl i de samlede data vil blive brugt mod dem - de skal derfor være helt skudsikre.
Som vi ser nu, tør ingen større analytiker end ikke stikke kursmål ud - ville være en fin start, hvis JP Morgan lagde for, når det nu er dem selv, der har inviteret Anavex til deres egen kongres. ( man kan kun blive inviteret med på JP Morgan)
Får vi som lovet resultaterne fra PDD OLE her lige om lidt, kan disse være med til at underbygge AD data, pga. sammenfaldet i indikationerne og virkemekanismen.En partneraftale med f.eks østriske ROCHE, ville passe rigtig fint sammen. Bare sproget og måske tilgange/mentaliteten ville de 5-6 tysker i ledelsen hos Anavex, måske kunne få et bedre konstruktivt samarbejde med en østriske ledelse, end med f.eks et US selskab.
Dette udover, at ROCHE netop lige mangler en partner med en ny Alzheimer platform, da de som tidligere skrevet, jo har skrottet deres egen fedtfjernelsestilgang.Pga. skattemæssig forhold, behøver der for min skyld ikke at komme alt for meget positivt kursmæssig før den 31. december - tror dog "desværre" ikke, at vi kan undgå dette, da Anavex jo har lovet flere milepæle i indeværende år.
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Anavex og Blarcamesine nævnt i "Nature"
Biogens Lecanumab sætter der spørgsmålstegn ved ...
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