Replies to post #45271 on Anavex Life Sciences Corp (AVXL)

[XenaLives]

Have we seen enough data to prove " A2-73 does not work on it's own"?

[JB3729]

Yes, that is my point too. We need a +donepezil formula because A2-73 does not work on it's own. We can't get FDA approval for straight A2-73. Therefore, we can't get patent protection of the drug without the formulation. Quite the conundrum.
§AVXL

We won't know how well A2-73 works alone until that data is released from the 2a trial. 8 of the 32 patients are being dosed with only A2-73. The pre-clinical data and the predicted clinical effect for A2-73 are positive.


http://www.anavex.com/?news=anavex-announces-positive-data-for-anavex-2-73-in-alzheimers-disease

10-month-old Tg2576 mice, both female and male, were treated with ANAVEX 2-73, which was administered orally on a daily basis for two months. Results showed that ANAVEX 2-73 significantly alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working memory (spontaneous alternation in a Y-maze) and long-term spatial reference memory (place learning in a water maze). The treatment also showed a statistically significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers.


Anavex Reports Predicted Clinical Effect of Both ANAVEX 2-73 and ANAVEX PLUS in a Humanized Cortical Cognitive Model for Alzheimer’s

When administered alone, ANAVEX 2-73 is expected to improve ADAS-Cog by 5 points at 12 weeks, and 3 point at 26 weeks, which is also likely to be detected clinically. As a point of reference, in human clinical trials 5 mg donepezil (Aricept®) was reported to show an average improvement of 3.6 points ADAS-Cog at 12 weeks and 2.6 at 26 weeks, respectively.

[bas2020]

That's incorrect... A2-73 IS shown to be effective on its own... it's just better with donepezil, for those who are moderately afflicted with AD and have a Beta Amyloid buildup.