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"...We are also pleased to report that the first cohort of schizophrenia patients in the ongoing ANAVEX®3-71-SZ-001 Phase 2 trial of ANAVEX®3-71 has been fully enrolled,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex..."
They had something like 93% of the participants signed up for the OLE. Compassionate use in Canada was granted by the Canadian Health Dept.
John k9uwa
Have been here since 2015
Some of the items kicked way, way, way (sniff, sob) down the road are kicked into 2nd half 2024! Being May 9th I would say that 2nd half is already upon us or is coming in 3 weeks elapsing in 6.6 months.
Need to listen again but I’m pretty sure he said “we were pulled by the EMA to proceed with submission, we didn’t push”…..so in essence, you are correct but I think his wording sounds slightly stronger. Crazy undervalued here, which is why I add more every month!
I saw George's optimistic comment and citation. The article quotes the science officer and the study Topline readout information. I see no pumping.
I stand by my comment. I used to believe fact checkers until they became factors in the "manufacturing consent" business spreading lies and hiding truths while people died.
You should put your paper mask back on to prevent unfilterable viruses. And sell your AVXL stock and go the f away.
"SLOWED BRAIN ATROPHY"....PUBLICIZE THAT VIA ALL AVAILABLE MEDIA !
there were 3 analysts in on the call: Jones, Wainwright and BI Research.
"...blarcamesine demonstrated a strong anti-amyloid effect, as indicated by a significant increase in the plasma Aß42/40 ratio, a validated biomarker of amyloid beta pathology. MRI scans revealed a notable reduction in brain volume loss across various brain regions, including the whole brain.
In terms of safety, the treatment-emergent adverse events primarily included transient and mostly mild to moderate dizziness, reported in a proportion of participants during the titration and maintenance phases of blarcamesine administration..."
Alzheimer’s disease:
Full data from the blarcamesine in Alzheimer’s disease Phase 2b/3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a Marketing Authorisation application to the European Medicines Agency (EMA) under the Centralised Procedure is underway. The Marketing Authorisation would allow direct market access throughout the European Union for oral blarcamesine for the treatment of Alzheimer’s disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.[2]
Analysis of RNA sequencing (RNA-seq) of the placebo-controlled Phase 2b/3 blarcamesine trial in early Alzheimer’s disease is underway. Interim data expected by mid 2024.
Ongoing ATTENTION-AD open-label extension 96-week trial. Interim data expected in the second half of 2024.
Schizophrenia: The placebo-controlled ANAVEX®3-71-SZ-001 Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia is well underway with the first cohort of schizophrenia patients fully enrolled.
Parkinson’s disease: Initiation of ANAVEX®2-73 imaging-focused trial and Phase 2b/3 6 month trial is expected in the second half of 2024.
Rett syndrome: Continued positive Real World Evidence (RWE) feedback from Rett syndrome patients and caregivers from the ongoing open-label extension trial and Compassionate Use Program for patients who participated in the Phase 2/3 EXCELLENCE trial encourages us to continue our partnership with the Rett syndrome community and to proceed with a Phase 3 12-week efficacy study. An educational presentation will be provided at the 2024 IRSF Rett Syndrome Scientific Meeting, taking place June 18 – June 19, 2024. ANAVEX®2-73 had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.
Fragile X: New disease-specific, translatable, and objective biomarker data generated with ANAVEX®2-73, supporting the initiation of the potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial will be presented at the 19th National Fragile X Foundation Conference, taking place July 25 – July 28, 2024.
New Rare disease: Initiation of potentially pivotal ANAVEX®2-73 Phase 2/3 clinical trial.
Publications: Continued clinical publications involving ANAVEX®2-73 and ANAVEX®3-71.
https://www.anavex.com/post/anavex-life-sciences-reports-fiscal-2024-second-quarter-financial-results-and-provides-business?mc_cid=f5277b644b&mc_eid=f6eb855b0a
Good luck and GOD bless,
"where the next Rett trial" Part of the last one was in Canada and the RETT ORG of Canada is pushing for more. Plus they have the OLE of previous trial.
John k9uwa
Read the GREAT NEW ARTiCLE
Anavex Life Sciences Alzheimer's Treatment Brings Hope to Millions
"...The study's outcome represents a noteworthy milestone, with blarcamesine being among the first drugs to exhibit efficacy on biomarkers of neurodegeneration. Michael Weiner, MD, professor of radiology, biomedical imaging, medicine, psychiatry, and neurology at the University of California, San Francisco, and principal investigator of the Alzheimer's Disease Neuroimaging Initiative, expressed enthusiasm over the study's results, particularly its ability to objectively slow markers of neurodegeneration...."
GREAT CONF CALL.JUST HOLD ON TIGHT LOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOONGS
This is a very nice non-academic article from Anavex's PR machine to a nice general information website. It is not peer-reviewed or academic. It is found quickly by George, who finds most things on this board. George will likely find the peer-review article first when it drops.
It was good, wise, kind and respectful for George to bring this article to the board.
As to the weasels who use fact-checkers, since the fact-checkers have been converted into Stalinist agit-prop enablers, both the fact checkers and the weasels who cite them should generally be discounted as self-serving ax grinders of the first rank.
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Anavex®Life Sciences Corp. (the “Company”) is a clinical stage biopharmaceutical company engaged in the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including drug candidates to treat Alzheimer’s disease, other central nervous system (“CNS”) diseases, pain and various types of cancer. The Company’s lead compound ANAVEX®2-73 is being developed to treat Alzheimer’s disease, Parkinson’s disease and potentially other central nervous system diseases, including rare diseases, such as Rett syndrome.
Anavex®Life Sciences’ lead drug candidate, ANAVEX®2-73, recently completed successfully a Phase 2a clinical trial for Alzheimer’s disease. 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. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex® a research grant to develop ANAVEX®2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX®2-73 into a Parkinson’s disease clinical trial. ANAVEX®3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions.
The Company is in preparation for ANAVEX®2-73 for a Phase 2/3, placebo-controlled trial in Alzheimer’s disease as well as a Phase 2, placebo-controlled trial in Rett syndrome, for which the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for ANAVEX®2-73 and a Phase 2, placebo-controlled trial in Parkinson’s disease.
Headquartered in New York, Anavex® Life Sciences is an American publicly traded corporation on Nasdaq quoted as AVXL
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