Anavex Life Sciences Receives Regulatory Approval
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Posted On: 06/04/2020 8:41:44 AM
Anavex Life Sciences Receives Regulatory Approval from Health Canada and UK MHRA Expanding Phase 2b/3 ANAVEX®2-73 (blarcamesine) into Multinational Clinical Trial for Alzheimer’s Disease
Looks like great news to me,
Fletch
NEW YORK – June 4, 2020 – 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 it has received a No Objection Letter from Health Canada as well as Clinical Trial Authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to expand the Phase 2b/3 double-blind, randomized, placebo-controlled safety and efficacy trial (Study ANAVEX®2-73-AD-004) of ANAVEX®2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into Canada and UK, respectively.
The 48-week Phase 2b/3 study ANAVEX®2-73-AD-004 (ClinicalTrials.gov NCT03790709) of ANAVEX®2-73 (blarcamesine) using biomarker and precision medicine in 450 patients with early Alzheimer’s disease is ongoing and currently over 50% enrolled.
“We are excited to receive the regulatory approvals for this Phase 2b/3 study for patients seeking treatment for Alzheimer’s disease,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “This expansion into North America and Europe should accelerate the completion of the enrollment of the ongoing ANAVEX®2-73-AD-004 Alzheimer’s disease Phase 2b/3 trial with ANAVEX®2-73 (blarcamesine).”
http://www.anavex.com/5927-2/
Looks like great news to me,
Fletch
NEW YORK – June 4, 2020 – 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 it has received a No Objection Letter from Health Canada as well as Clinical Trial Authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) to expand the Phase 2b/3 double-blind, randomized, placebo-controlled safety and efficacy trial (Study ANAVEX®2-73-AD-004) of ANAVEX®2-73 (blarcamesine) for the treatment of early Alzheimer’s disease into Canada and UK, respectively.
The 48-week Phase 2b/3 study ANAVEX®2-73-AD-004 (ClinicalTrials.gov NCT03790709) of ANAVEX®2-73 (blarcamesine) using biomarker and precision medicine in 450 patients with early Alzheimer’s disease is ongoing and currently over 50% enrolled.
“We are excited to receive the regulatory approvals for this Phase 2b/3 study for patients seeking treatment for Alzheimer’s disease,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “This expansion into North America and Europe should accelerate the completion of the enrollment of the ongoing ANAVEX®2-73-AD-004 Alzheimer’s disease Phase 2b/3 trial with ANAVEX®2-73 (blarcamesine).”
http://www.anavex.com/5927-2/
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