blarcamesine IV (Anavex 2-73 IV) / Anavex - LARVOL DELTA

Anavex Life Sciences Receives Michael J. Fox Foundation Grant for Clinical Study of ANAVEX 2-73 (blarcamesine) in People with Parkinson’s Disease (GlobeNewswire) - "Anavex Life Sciences...today announced that it has been awarded a research grant of $995,862.51 from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to develop ANAVEX®2-73 (blarcamesine) for the treatment of Parkinson’s disease. The award will explore utilization of PET imaging biomarkers to enable measurement of target engagement and pathway activation of the sigma-1 receptor (SIGMAR1) with clinically relevant doses in people with Parkinson’s disease."

Financing • CNS Disorders • Parkinson's Disease

Anavex Life Sciences reports newly published data on Alzheimer's disease research demonstrate the neuroprotective features of the sigma-1 receptor (GlobeNewswire) - "New data published in the current issue of the peer-reviewed scientific journal Neurotoxicity Research1 confirm that sigma-1 agonists, including multiple investigational compounds from Anavex Life Sciences...induce an anti-oxidant effect and protect mitochondrial function in pathological central nervous system conditions. In addition, another recent publication in the peer-reviewed scientific journal, Behavioural Brain Research2, confirms that the absence of sigma-1 receptor function exacerbates amyloid toxicity and increases learning impairments in pharmacologic and genetic mouse models of Alzheimer’s disease....The Neurotoxicity Research publication provides further insight on the mechanism of three Anavex sigma-1 receptor (S1R) agonists, ANAVEX®2-73, ANAVEX®1-41, and ANAVEX®3-71, which are all being studied in neurodegenerative diseases..."

Preclinical • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Anavex: CTAD 2016 (Anavex) - "Low-High dose was statistically significant to affect MMSE-Δ and ERP-Δ scores with MMSE-Δ (p=0.0285) and ERP-Δ (p=0.0168), respectively"

P2a data • Alzheimer's Disease

Anavex Life Sciences announces data on 41-week treatment of Anavex 2-73 for patients with Alzheimer’s disease − Investigational treatment suggests to curb cognitive and functional decline (GlobeNewswire) - P2, N=32; NCT02244541; "Anavex Life Sciences...today announced a positive 41-week update from its Phase 2a study in mild-to-moderate Alzheimer’s disease (AD) patients for ANAVEX 2-73, which targets cellular homeostasis. At 41 weeks, Alzheimer’s patients taking a daily oral dose of ANAVEX 2-73 in the exploratory, not yet dose optimized Phase 2a clinical trial, showed a stabilization of cognitive and functional measures."

P2a data • Alzheimer's Disease

Anavex Life Sciences announces 12-month data of Anavex 2-73 in a Phase 2a study in mild-to-moderate Alzheimer’s disease patients (GlobeNewswire) - P2, N=32; NCT02244541; "Anavex Life Sciences...today announced a positive 57-week update from its Phase 2a study in mild-to-moderate Alzheimer’s disease (AD) patients for ANAVEX 2-73, which targets cellular homeostasis. The study met both primary and secondary endpoints. At 57 weeks, Alzheimer’s patients taking a daily oral dose between 10mg and 50mg, ANAVEX 2-73 was well tolerated. There were no clinically significant treatment-related adverse events and no serious adverse events."

P2a data • Alzheimer's Disease

Anavex to present at 4th Annual OktoberINVESTfest Conference (GlobeNewswire) - "Anavex Life Sciences...today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the 4th annual OktoberINVESTfest investors conference on Tuesday, October 13, 2015 at 2:30 p.m. ET....In his presentation, Dr. Missling will provide an overview of Anavex’s ongoing Phase 2a clinical trial of ANAVEX™ 2-73 in Alzheimer’s patients. Full PART A and preliminary PART B Phase 2a clinical trial data will be presented at the CTAD conference on November 7, 2015."

Anticipated P2a data • Alzheimer's Disease

Anavex Life Sciences reports new mechanism of action data related to Anavex compounds targeting sigma-1 receptor (GlobeNewswire) - "Anavex Life Sciences...announced today the presentation of new mechanism of action data related to ANAVEX compounds targeting the sigma-1 receptor at the AD/PDTM 2017 Meeting....Goguadze N et al presented preclinical data indicating that in addition to reducing oxidative stress, ANAVEX 2-73, ANAVEX 3-71 and ANAVEX 1-41 also demonstrated protective effects of the mitochondrial enzyme complexes I and IV during pathological conditions."

Preclinical • Alzheimer's Disease

Anavex Life Sciences Presents ANAVEX 2-73 (blarcamesine) Data at 12th Clinical Trials on Alzheimer’s Disease (CTAD) 2019 Conference (GlobeNewswire, Anavex Life Sciences Corp.) - P2a, N=32; NCT02756858 (ANAVEX2-73-003); Sponsor: Anavex; "Interim 2-Year (104)-Week) data from the Phase 2a ANAVEX 2-73 (blarcamesine) extension study, with Alzheimer’s disease patients followed for up to five years, will be presented at the 12th Clinical Trials On Alzheimer's Disease (CTAD) 2019 Conference....'These results confirm the rationale to advance the ANAVEX 2-73 (blarcamesine) Alzheimer’s disease program through the ongoing Phase 2b/3 Alzheimer’s disease clinical study,'....'The data also establishes the findings of two further gut microbiota family biomarkers linked to improved response with ANAVEX 2-73 (blarcamesine).'"

Late-breaking abstract • P2a data • Real-World Evidence

Anavex nabs new patent in U.S. for Alzheimer’s disease (SeekingAlpha) - "The USPTO grants Anavex Life Sciences...U.S. Patent No. 10,426,754 to support Company's, ANAVEX 2-73 (blarcamesine) for the treatment of Alzheimer’s disease...Anavex’s newest patent is expected to remain in force at least until 2037."

Patent

Anavex Life Sciences Reports Fiscal 2019 Third Quarter Financial Results And Provides Clinical Study Updates (GlobeNewswire, Anavex Life Sciences Corp.) - "ANAVEX®2-73 (blarcamesine) Program Update:. Enrollments for the U.S. Phase 2 Rett syndrome study1 and the AVATAR Rett syndrome study2 of ANAVEX®2-73 (blarcamesine) are advancing with high priority....The enrollment of the Phase 2 ANAVEX®2-73 (blarcamesine) Parkinson’s disease dementia (PDD) study is proceeding well and is getting closer to reach completion. At the request of investigators in order to offer all participants of the clinical study access to ANAVEX®2-73 (blarcamesine) a voluntary extension of this study is in preparation including microbiome assessment....Research and development expenses have increased in the current fiscal year as a result of expenses incurred in connection with the advancement of clinical studies for ANAVEX®2-73 (blarcamesine)."

Clinical • Commercial • Enrollment status • Trial status

People with Parkinson's disease dementia sought for drug trial (Yass Tribune) - "A CLINICAL trial evaluating an experimental drug as a treatment for Parkinson's disease dementia is recruiting volunteers. The phase 2 study of Anavex 2-73 will be conducted...in Melbourne....'The clinical trial will seek to measure the neuroprotective effects of Anavex 2-73 and its ability to re-establish the normal function of cells'...Parkinson's disease patients aged 50 and over who have been diagnosed with dementia will be recruited for the trial....Researchers will evaluate the impact of the treatment on cognition as well as motor function and sleep quality."

Enrollment open • New P2 trial

Anavex Life Sciences reports fiscal 2019 second quarter financial results and provides clinical study updates (Anavex Press Release, Anavex Press Release) - "Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study is proceeding as planned with over 20% patients enrolled to date."

Enrollment status

Anavex Life Sciences reports fiscal 2019 second quarter financial results and provides clinical study updates (Anavex Press Release, Anavex Press Release) - "Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study is proceeding as planned with over 20% patients enrolled to date."

Enrollment status

Anavex Life Sciences Reports Fiscal 2019 First Quarter Financial Results And Provides Clinical Study Updates (GlobeNewswire, Anavex Life Sciences Corp.) - "Enrollment for the Phase 2b/3 ANAVEX®2-73 Alzheimer’s disease (AD) study 2 is proceeding as planned with over 80 patients screened to date...Operating expenses for first quarter fiscal 2019 of $7.5 million compared to $4.1 million for the comparative fiscal quarter. Research and development expenses increased as a result of expenses incurred in connection with the advancement of clinical studies for ANAVEX®2-73, and non-recurring expenses of approximately $1.0 million associated with large-scale manufacturing of ANAVEX®2-73 in quantities reserved for potential future commercial use."

Commercial • Enrollment status