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Wednesday, September 21, 2016 7:12:04 PM
Heres the link:
http://act-ad.org/resources/whats-new-anavexan-update/
What’s New at Anavex/An Update
A year ago, we featured a Q & A with CEO Christopher U. Missling, Ph.D., from Anavex Life Sciences Corp. Anavex is a biopharmaceutical company based in New York City and serves as one of ACT-AD’s sponsors. We recently circled back with the team at Anavex to get an update. Please note that the views and opinions of Anavex are purely its own.
Q: In our last interview, we discussed your lead drug candidate, ANAVEX 2-73. Could you give us an update on this?
A: Last year, we started the Phase 2a trial in mild-to-moderate Alzheimer’s patients with the oral compound, ANAVEX 2-73. It acts by selectively activating the stress reducing protein, the sigma-1 receptor, and muscarinic receptors, which are believed to reduce cognitive impairment. In November 2015, we presented five-week data, and recently, at AAIC 2016, we presented preliminary 31-week safety and exploratory efficacy data. So we have been actively advancing the trial.
Q: What have you found in this trial?
A: Preliminary Phase 2a data demonstrated that the study met the primary objective of safety as ANAVEX 2-73 was well tolerated and results were consistent with prior Phase 1 clinical trial data. The secondary objectives were also met, with ANAVEX 2-73 showing what appears to be a converging and consistent response for all quantitative endpoints. This includes cognitive and functional measures: Mini Mental State Examination (MMSE), Alzheimer’s Disease Co-operative Study – Activities of Daily Living (ADCS-ADL), as well as Cogstate and electroencephalographic activity and event-related potentials (EEG/ERP), which consistently demonstrated improvement and stabilization from baseline in a patient population that would normally be expected to experience ongoing cognitive and functional decline.
Additionally, the Phase 2a data demonstrated positive unexpected therapeutic response events, such as improved mood, improved social engagement, and increased independent activities through 31 weeks. ANAVEX 2-73 also showed preliminary beneficial effects on reducing insomnia, agitation, and anxiety, which may suggest additional important roles of ANAVEX 2-73 in conditions correlated with multiple underlying psychiatric diseases and dementia.
The purpose of this adaptive and Population PK Phase 2a trial was specifically designed to get all relevant information needed to be able to move as efficiently as possible into larger studies. Given the positive data, we are encouraged to proceed with the plan to prepare a larger Phase 2/3 trial, for which planning is underway.
Q: What are your thoughts on the next steps for this drug?
A: The new findings this year were the observation of positive efficacy with ANAVEX 2-73 in neurodevelopmental rare disease models such as Rett syndrome, Infantile Spasms and Fragile X, Autism-related disorders. The distinct mechanistic nature of ANAVEX 2-73 to address both neurodegenerative and neurodevelopmental diseases, which have cognitive impairment in common, suggests the compound could be a candidate treatment for a precision medicine approach across a spectrum of different neurological and psychiatric diseases alike.
Two orphan designations by the FDA for ANAVEX 2-73 support the exploration of ANAVEX 2-73 as a potential therapeutic in these disorders coupled with positive human safety data.
Q: What motivates Anavex to support the work of ACT-AD?
A: We understand the pursuit to provide relief to all those affected by Alzheimer’s disease and dementia requires a team effort to solve the current unmet need of a lack of a viable therapeutics. We find the Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) Coalition to be one of the leaders in the Alzheimer’s research space, and we look forward to continuing to work with ACT-AD to advance awareness about the importance of this research.
Recent AVXL News
- Anavex Life Sciences to Present at the H.C. Wainwright 5th Annual Neuro Perspectives Virtual Conference • GlobeNewswire Inc. • 06/20/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
- Anavex Life Sciences Announces Expansion of Leadership Team • GlobeNewswire Inc. • 05/22/2024 11:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
- Anavex Life Sciences Reports Fiscal 2024 Second Quarter Financial Results and Provides Business Update • GlobeNewswire Inc. • 05/09/2024 11:30:00 AM
- The Gross Law Firm Announces the Filing of a Securities Class Action on Behalf of Anavex Life Sciences Corporation(AVXL) Shareholders • PR Newswire (US) • 05/07/2024 09:45:00 AM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 05/06/2024 10:03:33 AM
- Anavex Life Sciences Corporation Sued for Securities Law Violations - Contact The Gross Law Firm Before May 13, 2024 to Discuss Your Rights - AVXL • PR Newswire (US) • 05/03/2024 09:45:00 AM
- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
- Contact The Gross Law Firm by May 13, 2024 Deadline to Join Class Action Against Anavex Life Sciences Corporation(AVXL) • PR Newswire (US) • 04/19/2024 09:45:00 AM
- The Gross Law Firm Reminds Shareholders of a Lead Plaintiff Deadline of May 13, 2024 in Anavex Life Sciences Lawsuit - AVXL • PR Newswire (US) • 04/16/2024 09:45:00 AM
- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/12/2024 09:45:00 AM
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- Class Action Filed Against Anavex Life Sciences Corporation (AVXL) - May 13, 2024 Deadline to Join - Contact The Gross Law Firm • PR Newswire (US) • 04/09/2024 09:45:00 AM
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- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 04/02/2024 09:45:00 AM
- Lost Money on Anavex Life Sciences Corporation(AVXL)? Join Class Action Suit Seeking Recovery - Contact The Gross Law Firm • PR Newswire (US) • 03/29/2024 09:45:00 AM
- Investors who lost money on Anavex Life Sciences Corporation(AVXL) should contact The Gross Law Firm about pending Class Action - AVXL • PR Newswire (US) • 03/26/2024 09:45:00 AM
- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
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