Anavex Life Sciences Corp (AVXL)

[F1ash]

"Safety and tolerability: Adverse events (AEs): 13 of 22 subjects [Incidence 59.1%] experienced a total of 41 AEs. No serious adverse event was reported. There was no study discontinuation due to AEs. One (1) of the 41 AEs [2.4%] (headache) had its onset before dosing, thus it was the only non-treatment-emergent adverse event (non- TEAE). Most AEs (32) were of mild intensity (32/41 = 78.0%). The remaining nine (9) AEs were rated as moderate intensity (9/41 = 22.0%). Most TEAEs (31/40 = 77.5%) were of mild intensity. The remaining 9 TEAEs had moderate intensity and exclusively occurred at the highest dose levels 55 and 60 mg.
Dizziness was the most frequent AE (incidence: 11/41 = 26.8%). 8 episodes of dizziness were of mild intensity, the remaining 3 were of moderate intensity. All 11 cases of dizziness were reported by the AV2- 73 administered subjects.

The number of affected subjects increased with increasing dose from 2 of 6 (25%) subjects to 4 of 4 subjects (100%) at the 30 mg and 60 mg dose steps, respectively.

Headache was the second most common AE (7/41 = 17.0%).
Gastrointestinal effects were predominantly observed at the highest 60 mg dose.

The complaints were abdominal pain (1), nausea (2), vomiting (3), and acute diarrhea (1). Other side effects observed were one subject experienced euphoric mood and one subject presented with mild depressive symptoms, each at the highest dose levels.


In summary, there was a clear trend for dose dependence of both frequency and intensity of TEAEs across the AV2-73 dose levels from 1 to 60 mg. Three out of four subjects at 60 mg experienced in total 6 dose limiting TEAEs.
Vital signs: There were no dose related differences of BP, and resting HR. Analysis of ECGs did not reveal any dose-related or time- dependent changes and QT interval and QTcB didn’t reveal any clinically significant changes.
Clinical laboratory: No sign for any dose- or time-dependent changes for any of the hematology, biochemistry, and coagulation parameters could be detected.
Urinalysis: A number of marginal, clinically not significant out of normal results were observed throughout the entire study across all dose groups. No sign for any dose- or time-dependent changes for any of the tested urinalysis parameters could be detected.
Pharmacokinetics: ANAVEX2-73: The mean of maximum plasma concentration (C values of AV2-73 showed a dose dependent increase with exception of the 60 mg dose step.
The mean values of area under the plasma concentration-time curves from zero to last quantifiable point and to infinity (AUClast and AUCinf ) demonstrated a dose proportional linear increase. The mean time to maximum plasma concentration (tmax) values across all dose groups were about 1 to 2 h, with no tendency of dose dependence.

http://www.anavex.com/my_uploads/2014-11-14_Poster_Anavex_2-73_Phase_1_Study_CNS_Summit_2014.pdf


I'm not a lawyer but, if I was, I would rather be the plaintiff's lawyer than the defendant's lawyer if Ms. Sanchez breaks her hip because she was dizzy.


" So let me see if I have this correct Dr.? You administered a dose to a fragile old lady that healthy young men were apparently not even able to tolerate? And you thought this was a good idea? Do you have malpractice insurance? "