Anavex Life Sciences Corp (AVXL)

[nidan7500]

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W/understanding that everyone sees (a PROCESS) wherever they look, maybe others will. Consequently, the recent AVXL patent application presents as much A2-73 as it does the process for diagnosing, using EEG/ERP tool suite. So what you say? well they are defining a diagnostics process for A2-73-too suite use.
Note use of certain key words in text which lock this app to use of tool suite and sequential treatment process. If I am right this is very cleverly done. Much more potentially here than meets the eye on quick review. IMO.

Composition and method for treatment of Alzheimer's disease that includes ANAVEX2-73. Method of treatment of Alzheimer's disease using pharmaceutical compositions comprising ANAVEX2-73 according to an intermittent dosage regimen.

1. A pharmaceutical composition for the treatment of Alzheimer's disease comprising a therapeutically effective amount of ANAVEX2-73.

16. A method of treating Alzheimer's disease in a subject comprising administering to the subject a pharmaceutical composition according to claim 1.

[0002] Despite major efforts aimed at finding a treatment for Alzheimer's disease, progress in developing compounds that can relieve cognitive deficits associated with the disease has been slow. ANAVEX2-73 or A-273 (tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride) is a compound which is believed to bind to sigma-1 and muscarinic acetylcholine receptors with affinities in the low micromolar range. ANAVEX2-73 has the chemical structure:

[0005] Reference is made to U.S. Patent Publication No. 2014/0296211 entitled "ANAVEX2-73 AND CERTAIN ANTICHOLINESTERASE INHIBITORS COMPOSITION AND METHOD FOR NEUROPROTECTION," to Vamvakides et al., filed Jul. 12, 2013; U.S. Ser. No. 62/065,833 entitled "A19-144, A2-73 AND CERTAIN ANTICHOLINESTERASE INHIBITOR COMPOSITIONS AND METHOD FOR ANTI-SEIZURE THERAPY," filed Oct. 20, 2014; U.S. Patent application entitled "CRYSTAL FORMS OF TETRAHYDRO-N,N-DIMETHYL-2,2-DIPHENYL-3-FURANMETHANAMINE HYDROCHLORIDE, PROCESSES OF MAKING SUCH FORMS, AND THEIR PHARMACEUTICAL COMPOSITIONS" and filed on date even herewith; U.S. Patent application entitled "ENANTIOMERS OF A2-73, ANALOGUES, AND SIGMA AGONIST ACTIVITY" and filed on date even herewith. The teaching of these applications and publications and all references cited herein are incorporated by reference in their entirety.
0006] The present disclosure comprises a pharmaceutical composition for the treatment of Alzheimer's disease comprising a therapeutically effective amount of ANAVEX2-73. Particular reference is made to treatment with the composition wherein the Alzheimer's disease is mild-to-moderate, and more particularly wherein the ANAVEX2-73 is characterized by the PXRD pattern shown in FIG. 1 as well as characterized by the thermogravimetric analysis of FIG. 2a or FIG. 2b and characterized by the differential scanning calorimetry analysis of FIG. 3a, 3b, or 3c.

[0012] Attention is brought to the dosing period and the resting period in the range of a lower limit of about 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days, 10 days, 11 days, 12 days, 13 days, and 14 days to an upper limit of about 28 days, 27 days, 26 days, 25 days, 24 days, 23 days, 22 days, 21 days, 20 days, 19, days, 18 days, 17 days, 16 days, 15 days, and 14 days. Also noted is the dosing period of between about 1 day and 12 days and the resting period is between about 1 day and 12 days with particular reference to a dosing period is 12 days and resting period is 12 days. Such regimen is usefully employed wherein the therapeutically effective amount of said pharmaceutical composition of ANAVEX2-73 is about 1 mg to about 60 mg and particularly about 30 mg to about 50 mg, and particularly for oral dosage forms. Also contemplated are ANAVEX2-73 dosages of about 3 mg to about 5 mg and particularly with intravenous administration.
0028] Various embodiments of the disclosure are discussed in detail below. While specific implementations are discussed, it should be understood that this is done for illustration purposes only. A person skilled in the relevant art will recognize that other components and configurations may be used without parting from the spirit and scope of the disclosure.
[0044] Table 2 demonstrates the effects of the ANAVEX2-73 dosage regimen on the cognitive performance of the twelve subjects at baseline and day 36 following the on-off-on ANAVEX2-73 dosing regimen, as measured by the target detection task of the ERP test. Table 2 also provides target detection task data for the healthy control group. As shown in Table 2, the button press accuracy was improved for subjects undergoing the ANAVEX2-73 dosage regimen as compared to the baseline. Additionally, the median reaction time and the false alarm percentage was reduced for the ANAVEX2-73 administered subjects as compared to the baseline. The healthy control group out-performed the day 36 ANAVEX2-73 subjects in button press accuracy and median reaction time. However, the day 36 ANAVEX2-73 subjects out-performed the healthy control group in false alarm percentage. The data provided in Table 2 indicates that ANAVEX2-73 administration improves both the accuracy and the reaction time of subjects performing the target detection task of the ERP test.

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