Anavex Life Sciences Corp (AVXL)

[JB3729]

I doubt it, and think that is why both are required for approval.

This is another indictment against the drug as in Lilly's early findings during this third attempt that the drug is not helping the functional aspect of an AD patient's life. Can there be real cognitive improvement if it does not translate into functional improvement, too?

This is what Anavex has told us about the A2-73 trial patients, so far -

“This is the first time the investigational drug ANAVEX 2-73 has been administered to Alzheimer’s patients. In addition to the positive EEG/ERP P300 biomarker signal, the feedback we’ve had so far is that patients and care providers have noticed both cognitive and functional improvement, increased alertness, improvement in activities of daily living, greater organization and a requirement for less prompting,” said study’s principal investigator Dr. Stephen Macfarlane, FRANZCP, Associate Professor and Director of Aged Psychiatry at The Alfred Hospital. “Subsequent to the positive initial feedback, we are applying to expand the extension period from 26 weeks to 52 weeks at the request of the participants.”
http://www.anavex.com/?news=anavex-presents-positive-initial-phase-2a-study-data-with-anavex-2-73-showing-early-evidence-of-improving-cognition-in-patients-with-alzheimers-disease-at-aaic-2015


All patients who completed PART A volunteered to continue in the longitudinal PART B extension study.

“While it is of prime importance to have confirmed that both the primary and secondary endpoints of the trial have been met, it is extremely encouraging to see the emergence of such strong cognitive signals after only 5 weeks of treatment. Such an outcome in a trial such as this is unprecedented in my experience, and the current results suggest that ANAVEX 2-73 could potentially make a significant difference in patients’ lives,” said Associate Professor Stephen Macfarlane, FRANZCP, Director of Aged Psychiatry at Alfred Health, who conducted the study. “We continue to receive extremely positive feedback about the effects of the drug from our study participants and their caregivers. The results justify a prospective comparison with current standard of care in a larger clinical trial.”
http://www.anavex.com/?news=anavex-announces-positive-primary-and-secondary-endpoints-were-achieved-in-a-phase-2a-clinical-trial-of-anavex-2-73-in-alzheimers-disease%e2%80%8e


(Nasdaq: AVXL) today announced that the Company has received the approval from the Ethics Committee in Australia to extend the ongoing Phase 2a Alzheimer’s trial, which had been requested by patients and their caregivers.

“We are receiving continued positive feedback about the effects of ANAVEX 2-73 from our study participants and their caregivers,” said Associate Professor Stephen Macfarlane, FRANZCP, Director of Aged Psychiatry at Alfred Health and the Principal Investigator of the study. “In addition to the measured cognitive and functional benefits witnessed so far, an overall improvement in mood and decrease in agitation has been anecdotally reported. We believe that extending the study will lead us to an increased understanding of the long-term effects of ANAVEX 2-73.”
http://www.anavex.com/?news=anavex-announces-two-year-clinical-extension-study-of-anavex-2-73-and-presents-phase-2a-dose-response-analysis-at-aat-conference