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tredenwater2
A Very-extremely Impressive list-plan...thanks....MANY-happy folks-families ...This will take guts and brains to do...BEST TO ALL.
georgejji,
falconer66a, thanks for relating your your story about Stage 4 CKD and how you fought back.
Anyone have an informed update on EMA-AVXL plans or Pubs? TIA
That was a 1 share trade at that price....Steady_ T...SO WHAT? Bubble is fine, attitude matters.
5.70
+0.24
(+4.40%) AH...keep those prayers coming.
Looking fwd to the day-time when AVXL SP is based on clinical value and technical results and not on mood swings by some guy on a raft.
Refreshing to see/read about FDA finally abandoning the brain Plaque model as root cause for AD and CNS diseases . Now WHAT ? CNS modeling for multiple human CNS diseases will/should trigger a re-thinking of the old science links-assumptions . We'll see if BP ready for an evaluation of their basic research methods? How will WS deal w/the shake up soon to follow? AVXL my end up leading them out of the wilderness.
We have seen recently that a factor in EMA support for AVXL A 2-73 is that much of EU does not use or have technical capability yet and $$$ to conduct (ARIA) imaging abnormalities . This work would indicate that is not a factor in EU MED approval cycles at this point.
Importantly, the trial also assessed a key secondary composite endpoint, CDR-SB, which showed significant improvements in both the 30 mg and 50 mg treatment groups at Week 48. This endpoint is recommended as an alternative primary endpoint for early Alzheimer’s disease in recent FDA guidance.
The efficacy of blarcamesine was further supported by biomarker data. The drug demonstrated positive effects on plasma Aß42/40 ratio and reduced brain atrophy. Specifically, blarcamesine slowed brain atrophy by 37.6% in whole brain measurements, 63.5% in total grey matter, and 25.1% in lateral ventricles.
Dr. Sabbagh emphasized the potential advantages of blarcamesine as an oral Alzheimer’s disease medication, noting its clinical benefits on cognition and neurodegeneration, coupled with a favorable safety profile. Unlike some anti-amyloid therapies, blarcamesine did not show evidence of neurological tissue damage such as hemorrhage or Amyloid-related imaging abnormalities (ARIA) in neuroimaging evaluations.
The safety profile of blarcamesine suggests that routine MRI monitoring may not be necessary, potentially simplifying treatment administration. The most common treatment-emergent adverse event was dizziness, which was generally mild to moderate and transient. This side effect appeared manageable through adjusted titration schedules and nighttime dosing.
Anavex Life Sciences plans to submit a full regulatory application for blarcamesine to the European Medicines Agency (EMA) in Q4 2024. The company believes that the oral administration and safety profile of blarcamesine could reduce barriers to treatment access for a diverse population of early Alzheimer’s disease patients.
"While this Aß42-related hypothesis may turn out to be a part of what causes and encourages progression of Alzheimer’s, it is a very complex disease, and most researchers do not believe Alzheimer’s is driven by only one biological mechanism,"
So then, what has the FDA been spending all it's time and (OUR) money on for the past 50+ years?
It looks like it will/may be one of THOSE DAYS...good luck to ALL
What if we first support RWE-RWD and SP as evidence of common sense growth & AVXL-improvement in CNS performance based on medical/clinical facts. What a concept. Other methods for projecting SP change may be fun but they are higher risk.
Consider what U.S. Senator Kennedy recently noted on how ,"70% of funding for FDA comes from BP.". "The more the ...."
Did this happen or NOT? If Y, then ? any (+/-) reactions ? TIA.
https://finance.yahoo.com/news/anavex-life-sciences-present-h-113000507.html
To Paraphrase what one great Brit has once famously noted..."this may not mark the end of the AD treatment Battle" but, "it will mark the end of the process for beginning an effective AD treatment."...
NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the H.C. Wainwright 26th Annual Global Investment Conference, being held September 9-11, 2024 in New York City.
The presentation will take place on Monday, September 9, 2024, at 11:30 a.m. ET at the Lotte New York Palace in New York, NY. An audio webcast will be accessible through the Investors section of the Company’s website at www.anavex.com. A replay of the session will be available later that day.
The 1,000 lb. elephant in the room that no one talks about is...The FDA process for change is obviously BROKEN, and it has been for a long time. It is time to stop banging our collective heads against the wall and do CHANGE, while we are still able. THE PROCESS IS BROKEN. It is totally ineffective. Continuing to do what has been done for decades is just DUMB. WE ALL OWN THIS.
Study this excellent alternative and move on...
https://professional.dce.harvard.edu/blog/7-reasons-why-change-management-strategies-fail-and-how-to-avoid-them/
https://curealz.org/news-and-events/updates-and-insights-from-our-ceo/
A well written , S.O.S..IMO.
This PR presents a change in style and content for AVXL leadership. Once such a change is committed to and executed, there is no going back to the old ways...CONGRATS...NOW AVXL MUST EXECUTE EFFECTIVELY. A big step forward to the next level of WGT..."In your Face attitude". After years of humility and quiet, we are due.
https://ih.advfn.com/stock-market/NASDAQ/anavex-life-sciences-AVXL/stock-news/94481314/anavex-life-sciences-to-present-at-the-h-c-wainwr
IMO, the SP downdraft today ($) is an exaggerated head fake.
An example of an excellent-factual-AVXL post ...WGT:
rlclark
Re: None
Monday, September 02, 2024 5:04:11 PM
Post#
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of 468794
Blarcamesine sustains benefits in early Alzheimer’s patients over year
Oral therapy found to slow cognitive, functional decline in Phase 2b/3 trial
Margarida Maia, PhD avatar
by Margarida Maia, PhD | August 1, 2024
A person presents charts in front of a crowd.
Nearly one year of treatment with blarcamesine (Anavex 2-73), a once-daily oral small molecule being developed by Anavex Life Sciences, slowed cognitive and functional decline in people with early Alzheimer’s disease, according to data from a global Phase 2b/3 clinical study.
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Researchers also observed that patients on blarcamesine had less atrophy in multiple areas of the brain compared with those on a placebo, and that the therapy led to a reduction of blood markers of neurodegeneration, with mostly mild and transient side effects.
“These data are very exciting, particularly in a study that can demonstrate objective slowing of markers of neurodegeneration,” Marwan Noel Sabbagh, MD, a professor of neurology at Barrow Neurological Institute in Phoenix, said in a press release.
Sabbagh, who chairs the scientific advisory board of Anavex, shared these data in an oral presentation, titled “Blarcamesine in Early Alzheimer’s Disease: Phase IIb/III Randomized Clinical Trial,” at the 2024 Alzheimer’s Association International Conference, held in Philadelphia and online.
In Alzheimer’s, misfolded proteins build up into toxic clumps that disrupt the normal functioning of nerve cells, leading to brain damage. This slowly impairs memory and thinking skills, and eventually the ability to carry out the simplest tasks in daily life.
“People living with early Alzheimer’s disease have the desire to maintain their sense of self for as long as possible,” said Juan Carlos Lopez-Talavera, MD, PhD, head of research and development at Anavex. “The study results provide the potential for people with more time to engage in meaningful activities.”
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July 11, 2024 News by Margarida Maia, PhD
FDA clears foralumab nasal spray for expanded use in Alzheimer’s
Blarcamesine designed to activate SIGMAR1 that helps nerve cells stay healthy
Being investigated in the form of an oral capsule, blarcamesine is designed to activate SIGMAR1, a protein that supports the health of nerve cells by helping them cope with stress and by increasing autophagy, which is a clearance mechanism that removes misfolded and clumped proteins, including those that cause Alzheimer’s.
“The advantage of blarcamesine is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its route of administration and good comparative safety profile,” Sabbagh said.
The Phase 2b/3 study (NCT03790709) included 508 patients, ages 60 to 85, with mild dementia or mild cognitive impairment due to Alzheimer’s. They were randomly assigned to blarcamesine at a dose of 30 or 50 mg, or to a placebo, once daily for 48 weeks, or nearly one year.
The study’s main goals were to evaluate the benefits of blarcamesine on cognition, using the Alzheimer’s Disease Assessment Scale-Cognition (ADAS-Cog13), and its effects on overall function, as assessed with the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL), over 48 weeks.
Researchers found blarcamesine significantly slowed cognitive decline by 34.6% at the 30 mg dose and by 38.5% at the 50 mg dose compared with the placebo. According to the March 2024 FDA Guidance for Early Alzheimer’s Disease, a cognitive test like ADAS-Cog13 can be used as the primary endpoint in early Alzheimer’s studies.
No significant differences in ADCS-ADL scores were observed between the blarcamesine and placebo groups, perhaps because the test is better suited for more advanced Alzheimer’s and may not capture changes in early stages as well, according to the company.
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Blarcamesine found to slow cognitive worsening
One of the study’s secondary goals was to watch for changes in the Clinical Dementia Rating Scale Sum of Boxes, which measures the degree of dementia and cognitive impairment. Blarcamesine was found to slow cognitive worsening by 28.6% at the 30 mg dose and by 26.5% at the 50 mg dose.
The blood levels of amyloid-beta 42/40 ratio — a measure that indicates less toxic clumps of the amyloid-beta protein, a hallmark of Alzheimer’s — were significantly reduced upon treatment with blarcamesine, as were those of neurofilament light protein, a marker of nerve cell damage.
Blarcamesine also slowed brain atrophy, which refers to the loss of nerve cells, including in the whole brain by 37.6%, in total gray matter by 63.5%, and in the lateral ventricles by 25.1%. The the lateral ventricles house cerebrospinal fluid, the liquid that flows around the brain and spinal cord.
“We believe the scalable and convenient features of blarcamesine could reduce crucial barriers within the currently complex healthcare ecosystem for Alzheimer’s disease and provide broader access to a diverse population with early Alzheimer’s disease,” Sabbagh said.
Safety data revealed no neurological tissue damage, such as bleeding or amyloid-related imaging abnormalities, a serious complication that has been reported with medications targeting the amyloid-beta protein.
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Dizziness was most common side effect reported
Consistent with earlier data, side effects tended to occur within the first 24 weeks, or six months, of treatment, and were mostly mild and transient, lasting for up to 11 days. The most common side effect reported with blarcamesine was dizziness.
“We like to thank all the people involved in the study for their invaluable contributions and we look forward to continuing our journey to address the high unmet need for Alzheimer’s disease patients with a potential new convenient orally available treatment option,” said Christopher Missling, PhD, Anavex’s president and CEO.
In addition to Alzheimer’s, the company is exploring the potential benefits of blarcamesine for other neurological diseases, such as Parkinson’s, Rett syndrome, and fragile X syndrome.
This presents an excellent opportunity for AVXL, IMO. This takes guts and facts...good to see...
georgejji
https://infomeddnews.com/anavex-tackles-cognitive-aging-and-related-disease-pathologies/
So many dots, so little time.
IMMO, our current CNS-new medicine discoveries are roughly analogous to where the Computer-linked desktop network -extended networks WW were in the early 70's. At that time the concepts of extended networks linking desktops together as an " Information-Knowledge SYSTEM" was just a fuzzy concept , often thought of as a "Cloud". Then BOOM, it all took off and almost overnight we had Linked information systems and WW networks...we have never even slowed down since that linking process began.
Guess what Boys and Girls...LINKED CNS MEDS (LCM' S ) and the linkages of NEW CNS MED possibilities-reality is about to happen. The remote islands of today's thought-knowledge desktop network of Application specific human meds has been (will be) obviated by massive CNS links made possible by little AVXL-CNS MEDS networks . That is my vision...you heard it here first.
Stand by, prepare the flight deck for air operations. It will begin any day now ...stand by. Lets see if we recognize the initial links when they happen. The technology is ready for linked thinking CNS med-networks to be demonstrated. ....AVXL will lead and explode as massive $$$ will follow. EMA may lead the AAAAHHHHAAA MOMENT.
5.92
+0.04
(+0.68%)
After hours: 4:05 PM EDT
Well, what's next? Will EU or USA lead the PR charge? Positive news or... more wait?
The office holders come back to the work in early Sept. and turn the lights back on for re-start.
Does EU still take vacation(code for shuts down) in August every year?