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ANAVEX MEETS ENDPOINTS PHASE2 RETT, page-38

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Bloody Nine

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09/02/22

03:21

Post #: 59444719
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Originally posted by Piton72: ↑

https://www.anavex.com/post/anavex-...formation-on-anavex-2-73-avatar-phase-3-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 provides supplemental information on the ANAVEX®2-73 (blarcamesine) AVATAR Phase 3 trial for the treatment of adult patients with Rett syndrome.

Following the successful completion of U.S. Phase 2 Rett syndrome study (ANAVEX®2-73-RS-001) as announced in December 2020, and the knowledge gained from it, the AVATAR study (ANAVEX®2-73-RS-002) appropriately updated endpoints according to ICH guidelines were approved by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and in Australia by the Human Research Ethics Committees (HREC), where the AVATAR study was conducted. Subsequently the AVATAR study was updated from a Phase 2 to a Phase 3 study. The January 2022 update to the trial description in ‘clinicaltrials.gov’ was not a real-time communication and may have given the wrong impression of a late change of trial endpoints / phase of the study, which is not the case.

Based on the results of the AVATAR Phase 3 study (ANAVEX®2-73-RS-002) and the prior successful U.S. Phase 2 (ANAVEX®2-73-RS-001) study in adult patients with Rett syndrome, Anavex is planning to meet with the FDA to discuss the approval pathway. There are no FDA-approved drugs for Rett syndrome. ANAVEX®2-73 has Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.

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Anyone else notice this article?

https://www.clinicaltrialsarena.com/analysis/rett-syndrome-endpoints/

Sums up and an interesting read...

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ANAVEX MEETS ENDPOINTS PHASE2 RETT, page-38

KGL sniffs 19% Cu from drilling at Rockface play in NT

Saturn’s stars have aligned for the gold explorer’s Apollo Project

Fast-track assaying yields 182 g/t gold for iTech at new NT play

Climate change to drive market trends to the moon

The Big Deal: Free-to-air TV swings the axe, but will it be enough as enormous sports deal bills loom?

Red Hill Minerals Signs $6.5 Million Agreement with Peel Mining to Explore Curnamona Project, NSW

Week 27 Wrap: "Election year" is here as UK Labour win contrasts France; Trump wins immunity & annual report season hushes ASX

Leo Lithium announces major divestment of flagship Goulamina project to Ganfeng

Tivan and EARTH AI gear up to commence fresh drilling at Sandover lead-silver project, NT

Has uranium run out of steam? An update on nuclear markets & developments ahead in FY25

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ANAVEX MEETS ENDPOINTS PHASE2 RETT, page-38

Top Stories

KGL sniffs 19% Cu from drilling at Rockface play in NT

Saturn’s stars have aligned for the gold explorer’s Apollo Project

Fast-track assaying yields 182 g/t gold for iTech at new NT play

Climate change to drive market trends to the moon

The Big Deal: Free-to-air TV swings the axe, but will it be enough as enormous sports deal bills loom?

Red Hill Minerals Signs $6.5 Million Agreement with Peel Mining to Explore Curnamona Project, NSW

Week 27 Wrap: "Election year" is here as UK Labour win contrasts France; Trump wins immunity & annual report season hushes ASX

Leo Lithium announces major divestment of flagship Goulamina project to Ganfeng

Tivan and EARTH AI gear up to commence fresh drilling at Sandover lead-silver project, NT

Has uranium run out of steam? An update on nuclear markets & developments ahead in FY25

Featured News

Buyers (Bids)

Sellers (Offers)

Featured News