I too was very frustrated by the lack of communication from the company. Hoping and wishing to have some magical PR that garners approval from the FDA to help millions and millions of patients worldwide while the SP skyrockets. I’ve come to the realization that Missling is doing the best he can with what he has. Contrary to the belief of many on this board I don’t think “ we got this”, yet! I think that Missling is providing data as it comes while trying to navigate the processes with the FDA.
Avatar data will be crucial. Hopefully it shows those on higher doses of the drug do better. This will bode well for the excellence trial as well. Hopefully we get the full results of the PDD data as well and just maybe we get BTD. With that being said I am not holding my breath. As I said before I don’t think this is a miracle drug but I do believe it has the potential to help patients live a better life. That is why I am invested.
Have to disagree with you here plexrec. Love your posts but in all fairness, the company has released a ton of information (i.e. communicated with its shareholders) over the past three months:
July 26th...TGD conducts a Q & A with Myles Udland of Yahoo Finance. (VERY well done, I might add)
Anavex planning a Phase 3 prevention trial of ANAVEX®2-73 including participants at risk for cognitive and functional decline related to Alzheimer's disease
NEW YORK, July 29, 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) disorders, today reported new data that established ANAVEX®2-73 to be a preventive treatment in the pharmacological model of Alzheimer's disease (AD). Pre-treatment with ANAVEX®2-73, repeated once daily for one week before the Aß (Abeta) challenge was protective in the Aß25-35 peptide model of Alzheimer's disease in mice. ANAVEX®2-73 significantly and dose-dependently prevented Aß25-35-induced biomarker-correlated cognitive impairments, which were assessed one week after the Aß (Abeta) insult during which no further ANAVEX®2-73 treatment took place.
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.1 SIGMAR1 also promotes autophagy and results in the degradation of amyloid-beta precursor protein (APP) thereby inhibiting Aß production2.
"We are excited about this data, which indicates the potential expansion for the ANAVEX®2-73 platform to find an effective Alzheimer's prevention therapy, which might benefit the entire field," said Christopher U. Missling, PhD, President & Chief Executive Officer of Anavex. "In addition to finding treatment options for Alzheimer's disease, we are also striving to find effective prevention therapies for this devastating disease, and this data might help advance this endeavor to address an area of high unmet medical need."
Data from this study will be submitted later this year for presentation at a scientific medical meeting.
Previously, a publication in Neuropharmacology noted that in a clinical study (ANAVEX2-73-002) of Alzheimer's disease patients, 57 weeks of oral once daily ANAVEX®2-73 treatment showed patients improved cognition scores by +2.0 points on MMSE, a 9% mean improvement from baseline to 57 weeks, corresponding to a calculated ADAS-Cog score change of -3.4 (improvement). In these same patients ANAVEX®2-73 also improved ADCS-ADL, by +4.9 points, a 7% mean improvement from baseline to 57 weeks.3
An extension of the published study (ANAVEX2-73-003) demonstrated that for the same patients at week 70 MMSE scores improved by +3.0, a 14% improvement from baseline, corresponding to a calculated ADAS-Cog score change of -5.1 (improvement). In these same patients, ANAVEX®2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks. The mean MMSE and ADCS-ADL baseline scores for these patients in this study were 22.3 and 71.1, respectively.4,5
This data seems to be consistent with the effect of ANAVEX®2-73 on cognition assessed in the recently completed placebo-controlled Phase 2 study of 132 patients with Parkinson's disease dementia (ANAVEX2-73-PDD-001) with once-daily administration of oral 30 mg ANAVEX®2-73, 50 mg ANAVEX®2-73 and placebo for 14 weeks. The observed statistically significant improvement of CDR system Episodic Memory of +42.22 between 50 mg ANAVEX®2-73 and placebo was also dose-dependent (p = 0.003).6 CDR system Episodic Memory has been shown to be highly correlated (70%) with the ADAS-Cog score (r = 0.7).7 The calculated corresponding ADAS-Cog mean change from baseline score is -1.9 (improvement) for patients in the 50 mg dose group, an 8% mean improvement from baseline to 14 weeks. The difference between the ANAVEX®2-73 group and the placebo group in the change from baseline at 14 weeks was a 4.0-point improvement of calculated corresponding ADAS-Cog score (p = 0.015).
The Company recently announced that it has exceeded its enrollment target for the ANAVEX®2-73 (blarcamesine) double-blind, placebo-controlled late-stage Phase 2b/3 study (ANAVEX2-73-004) in Alzheimer's disease.
Anavex Life Sciences' product portfolio platform includes orally available small molecule drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer's disease, Parkinson's disease and Rett syndrome and ANAVEX®3-71 for frontotemporal dementia.
Anavex Life Sciences to Participate in the BTIG Virtual Biotechnology Conference 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) disorders, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will participate in a fireside chat in the BTIG Virtual Biotechnology Conference 2021 on Tuesday, August 10, 2021 at 9:30 a.m. EDT.
Webcast for the conference will be available in the Investors section under "Events" of the Anavex corporate website at www.anavex.com. To listen to the live event, please contact a BTIG representative with interest.
Anavex Life Sciences Announces Publication of Foundational Data for ANAVEX(R)2-73 (blarcamesine) in Fragile X Syndrome (Autism)
Published in Scientific Reports, Results Highlight Reversal of Hyperactivity and Restoration of Associative Learning and Reduction of Anxiety, Phenotypes Associated with Fragile X Syndrome
Study Provides Proof-of-Concept for Advancing ANAVEX(R)2-73 (blarcamesine) into Phase 2/3 Fragile X Syndrome Clinical Trial
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 announced that preclinical data of ANAVEX(R)2-73 (blarcamesine) in Fragile X Syndrome were published in the peer-reviewed journal, Scientific Reports.
Fragile X Syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide. At present, there is no approved treatment for Fragile X Syndrome.
The study evaluated doses of ANAVEX(R)2-73 in Fmr1 knockout (KO) mice, a validated animal model for the disease, which resulted in the reversal of hyperactivity and restoration of associative learning as well as reduction in anxiety-like and perseverative behaviors. Positron emission tomography (PET) and ex vivo autoradiographic studies, using the highly selective SIGMAR1 PET ligand [F]FTC-146, demonstrated ANAVEX(R)2-73's dose dependent receptor occupancy. Additionally, ANAVEX(R)2-73 also restored pAkt and BDNF levels in the hippocampus, which are signaling pathways particularly affected in Fragile X Syndrome. ANAVEX(R)2-73 also showed a good safety profile.
"Testing novel drugs that can safely improve the symptoms of Fragile X Syndrome is a high priority," said Walter E. Kaufmann, M.D., Chief Medical Officer of Anavex and corresponding author of the paper. "The present findings support the viability of SIGMAR1 as a therapeutic target in Fragile X Syndrome, and the clinical potential of ANAVEX(R)2-73 (blarcamesine) in Fragile X Syndrome and other neurodevelopmental disorders."
The study, "Effects of the Sigma-1 Receptor Agonist Blarcamesine in a Murine Model of Fragile X Syndrome: Neurobehavioral Phenotypes and Receptor Occupancy," is the basis for a Phase 2/3 ANAVEX(R)2-73 study in Fragile X Syndrome. The fact that the investigation involved chronic administration, as opposed to acute dosing, provides additional evidence in favor of the clinical use of ANAVEX(R)2-73. Since the behavioral paradigms reflect the involvement of multiple cortical and subcortical regions, their marked improvement by ANAVEX(R)2-73 suggest widespread activation of SIGMAR1 by the drug and modulation of multiple neural pathways. Indeed, the observation of normalization of pAkt and BDNF levels after ANAVEX(R)2-73 administration, in a brain region critical for cognition and behavior, is also a finding with important implications for Fragile X Syndrome and other synaptic disorders.
Altogether, these neurobehavioral, biochemical, and imaging data demonstrate that corresponding doses of ANAVEX(R)2-73 that yield measurable receptor occupancy are effective for substantially correcting key synaptic and behavioral phenotypes in Fmr1 KO mice. The data also suggest that these positive effects are mediated by SIGMAR1 activation in multiple brain regions, where ANAVEX(R)2-73 binds to the receptor in a dose-dependent and genotype-independent manner. The study was supported by the FRAXA Research Foundation.
"We look forward to initiating a double-blind, placebo-controlled Phase 2/3 ANAVEX(R)2-73 study in Fragile X Syndrome," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We are intrigued about the clear preclinical data providing potential to expand the therapeutic profile of ANAVEX(R)2-73 into the largest portion of addressable market of autism spectrum disorder, Fragile X Syndrome. This is further evidence of the potential of ANAVEX(R)2-73 as a platform technology of precision medicine."
The full paper can be accessed online at: www.nature.com/articles/s41598-021-94079-7.
Anavex Life Sciences to Present at the H.C. Wainwright 23rd Annual Global Investment Conference
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) disorders, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the H.C. Wainwright 23Annual Global Investment Conference being held from September 13-15, 2021.
A webcast of the on-demand presentation will be available beginning Monday, September 13, 2021, at https://journey.ct.events/view/48684630-6af2-4c12-a206-f94233cde440 or on the Company's website at www.anavex.com. The on-demand presentation will open on September 13 at 7:00 A.M. (ET). A webcast replay will be accessible for 30 days following the event.
Anavex Life Sciences to Present at the 2021 Cantor Virtual Global Healthcare Conference
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) disorders, today announced that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 10:40 AM (ET). The conference is being held September 27-30, 2021.
A live audio webcast will be available at https://wsw.com/webcast/cantor12/avxl.ob/2514820 or on the Company's website at www.anavex.com. A webcast replay will be accessible for 30 days following the presentation.
Anavex Life Sciences Announces Participation at 5th Pharma Pricing, Reimbursement & Market Access 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) disorders, today announced that its President and Chief Executive Officer, Christopher U. Missling, PhD, will join a panel discussion titled, "Fragile X Syndrome Case Study: From Preclinical to Clinical, Making Drug Development Efficient through Community-based Collaboration" at the 5th Pharma Pricing, Reimbursement & Market Access 2021 conference on Wednesday, September 29 at 2:40 pm ET.
This Conference will provide an overview of global pricing, market access systems and cost management techniques, as well as in-depth discussion of some of the most current trends and changes. This Conference will bring together top pharmaceutical, biotechnology, and regulatory representatives under one roof that will address the key issues of the industry. It will be studied with the help of case studies and industry experiences. The virtual event is held September 28 - 29, 2021.
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