Anavex Life Sciences Corp (AVXL)

[JB3729]

I hope all other AVXL shareholders are as excited as I am regarding the huge "cushion" the early Phase 2 trial data provided us.

ANAVEX 2-73 showed in 83 percent (10/12) of patients positive cognitive effects during PART A of the study, which consists of a 36-day on-off-on not-yet-optimized dosing regimen to assess bioavailability. At day 36, the amplitude of the cognitive EEG/ERP biomarker P300 increased 38 percent from baseline. Published data suggests that a 38 percent increase is approximately 4 times higher than donepezil (Aricept®), the current standard of care, in the same timeframe.

Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect. The safety profile of ANAVEX 2-73 during Phase 2a appears consistent with the Phase 1 data; additional clinical data of the trial will be presented at future medical meetings.

4 times higher than donepezil(Aricept). 50% higher would have been extraordinary news! Big "cushion" in case future results aren't quite as good. Although, they may be better once the dosing regimen is optimized.

Looking out to the 6 month comparison, check out the P300 Change graph on the poster - http://goo.gl/8p4BoC

The trajectory of the Anavex 2-73 line is leaving the donepezil line in the dust. 4 times higher may escalate into 6 times or 8 times at the 6 month mark.

So how are the patients doing -

“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/?post_type=news&p=1491