Biotech Values

[north40000]

AVXL: 2nd of 2 releases from AAIC re efficacy data:

http://www.anavex.com/?news=anavex-presents-31-week-efficacy-data-from-phase-2a-study-of-anavex-2-73-in-alzheimers-patients-at-aaic-2016

Actual poster mentioned below:

http://www.anavex.com/wp-content/uploads/2016-07-27_Poster_AVXL_Wednesday_AAIC_July_2016_Final.pdf

"NEW YORK, NY – July 27, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a
clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of
neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system
(CNS) diseases, pain and various types of cancer, today announced efficacy data through 31 weeks from the
ongoing ANAVEX 2-73 Phase 2a study in mild-to-moderate Alzheimer’s patients presented in the second of two
posters at the Alzheimer’s Association International Conference® (AAIC) 2016.
Overall, efficacy results demonstrate what appears to be a converging and consistent response for all quantitative
endpoints through 31 weeks, including cognitive and functional measures: Mini Mental State Examination (MMSE),
Alzheimer’s Disease Co-operative Study – Activities of Daily Living (ADCS-ADL), Cogstate and
electroencephalographic activity and event-related potentials (EEG/ERP).
In a disease state where progression is invariable over time, a sustained or stable MMSE and ADCS-ADL score is
considered a positive outcome.
“The demonstration of an extended period of both cognitive and functional stability out to 31 weeks in a patient
population that would normally be expected to experience ongoing cognitive decline is an encouraging milestone in
the development of ANAVEX 2-73. The 31-week data also validates the earlier observation of improvements on
tasks within the Cogstate battery. The specificity and consistency of these benefits suggest that ANAVEX 2-73 can
sustain activation of attentional and working memory functions with repeated dosing in Alzheimer’s disease,” said
Associate Professor Stephen Macfarlane, FRANZCP, Head of Clinical Governance, Dementia Centre
HammondCare, who is conducting the study. “Of noticeable interest was also HAM-D data showing beneficial
effects of ANAVEX 2-73 on insomnia, agitation and anxiety at 31 weeks, which might suggest an additional
important role of ANAVEX 2-73 for the amelioration of behavioral and psychological symptoms of dementia (BPSD).”
The poster presentation is available on the publications page of the Anavex website.
“This clinical data together with prior preclinical findings seem to confirm ANAVEX 2-73’s selective activation of the
specific stress reducing and survival protein, Sigma-1 receptor. This seems to present a potential common pathway
for rescuing major neurodevelopmental and neurodegenerative disease mechanisms, like in Autism-related
disorders and Alzheimer’s disease. I believe the distinct mechanistic nature suggests the compound could be a
candidate treatment for a precision medicine approach across a spectrum of different neurological and psychiatric
diseases,” said Professor Harald Hampel, MD, PhD, Professor and AXA Research Fund Chair at Sorbonne
Universities’ Pierre and Marie Curie University (UPMC), Paris, France and member of Anavex’s Scientific Advisory
Board.
“By utilizing an adaptive design in our current ANAVEX 2-73 Phase 2a study, the treatment was finely adapted to the
patient’s response, sparing patients from unnecessary side effects and safeguarding patients’ well-being, as
evidenced by a high retention rate in this maximum tolerated dose (MTD) study,” said Christopher U. Missling, PhD,
President and Chief Executive Officer of Anavex. “We are encouraged to proceed with the plan to confirm the data in
a larger Phase 2/3 trial, for which planning is underway.”
About the ANAVEX 2-73 Phase 2a Study
1/3
The multi-center Phase 2a clinical trial of 32 mild-to-moderate Alzheimer’s patients consists of two parts. In PART A
ANAVEX 2-73 is administered during five weeks in a randomized, open-label study with adaptive design. PART B is
continued administration of ANAVEX 2-73 in a voluntary 52-week open-label extension, followed by an additional
voluntary 104-week extension study, allowing for the gathering of safety data for ANAVEX 2-73 cumulatively over
three years.
The primary endpoint of the Phase 2a trial is to establish safety, tolerability and maximum tolerated dose (MTD) of
ANAVEX 2-73. Secondary endpoints include exploratory cognitive as well as functional measures using Mini Mental
State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living
Inventory (ADCS-ADL), respectively.
Additional information regarding the ongoing Phase 2a clinical study is available from the U.S. National Institutes of
Health (NIH) clinical trials database at www.clinicaltrials.gov."

***********************************************