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Re: bb8675309 post# 324453

Wednesday, 08/04/2021 5:33:21 PM

Wednesday, August 04, 2021 5:33:21 PM

Post# of 458527
Great find bb867: Exceptional. Wonder what MJF and crew will say.

https://finance.yahoo.com/news/anavex-life-sciences-announces-anavex-110000682.html

Anavex Life Sciences Corp.
June 28, 2021



WOW...time for MJF and crew to stand up and push to be recognized. We have another strongest PDD/PD candidate w/real data for accelerated recognition actions all around, including FDA and 3rd party advocates. Building for Trifecta of A2-73 MOA.


NEW YORK, June 28, 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 that the predictive biomarker of response established with SIGMAR1 mRNA expression correlates significantly with responses in primary and secondary clinical efficacy endpoints from the proof-of-concept randomized, double-blind, placebo-controlled Phase 2 trial that randomized 132 patients with Parkinson’s disease dementia equally (ratio of 1:1:1) to target doses of 30mg, 50mg ANAVEX®2-73 or placebo, respectively.



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 Recent independent findings strengthen the understanding of the beneficial effect of SIGMAR1 activation as compensatory mechanism to chronic CNS diseases.2



ANAVEX®2-73 treatment resulted in significant (p = 0.035) mRNA expression increase of SIGMAR1, the gene encoding for the receptor targeted by ANAVEX®2-73, which correlated with clinical efficacy as measured by primary cognitive efficacy endpoints, CDR system Continuity of Attention (CoA) (p = 0.029) and CDR system Power of Attention (PoA) (p = 0.015), and secondary Parkinson’s efficacy endpoints Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)4, MDS-UPDRS Part III (p = 0.024) and MDS-UPDRS Total (p = 0.038).



Treatment with ANAVEX®2-73 not only slows the progression of motor and non-motor symptoms in moderately advanced patients with Parkinson’s. ANAVEX®2-73 also resulted in clinically meaningful improvements as measured by the global composite score of Parkinson’s disease symptom severity, MDS-UPDRS Total score on top of standard of care including dopaminergic therapy, levodopa and other anti-PD medications after 14 weeks of treatment, suggesting ANAVEX®2-73’s global capability of slowing and reversing symptoms that progress in Parkinson’s disease, an urgent unmet medical need.



Congratulations on the recognition AVXL team

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