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I was actually a little surprised that we didn't get the poster/details on this presentation from the company today.
JJ, you bring up a good point that no ACTC supported clinical trials have been announced. Below is a bit of DD around timelines for the program that I posted earlier this summer. Thanks to Talon for keying in on this bit of (worthy, I believe) speculation.
February 19-21, 2019, Anavex will be participating in the 7th World CNS Summit - Targeting Neurodegenerative Diseases.
From the event’s description:
New press coverage out of Australia: https://www.9news.com.au/2018/10/19/18/29/dementia-pill-clinical-trial-anavex-2-73
A masterpiece, Bio! Thank you.
And this seems like as a good a place as any to slip in a DD update with relation to Rudy Tanzi. Some time ago I posted about the Dec. 11 NYAS symposium, Alzheimer’s Disease Therapeutics: Alternatives to Amyloid, that Nell Rebowe is organizing with Dr. Rudy Tanzi and Dr. Howard Fillit of the Alzheimers's Drug Discovery Foundation. There is now an agenda for the event, and speaking along with Dr. Tanzi and Dr. Fillit, will be Dr. Missling:
Steve Kaminsky, PhD, comments on the upcoming Anavex Rett trial in his opening remarks for the Fall/Winter Rett Gazette:
Missed this one last week. On 9/26, Stephan Toutain, SVP, Operations, Anavex Life Sciences spoke at the Orphan Drugs & Rare Diseases 2018 Americas East Coast conference in Boston:
Investor2014, thanks for keeping us posted on the site activation numbers in the PDD trial. It's great that this information is available and I am encouraged by the currently reported progress. I thought you'd find this article from 2008 interesting — it examines the relationship between clinical trial site activation time and total enrollment cycle time: Site Activation: The Key to More Efficient Clinical Trials
At CTAD, in addition to the late-breaking oral presentation on the 148wk Phase 2a data, Anavex will have a poster focused on the Phase 2b/3 clinical trial methodology:
P91 - A Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-Week Trial of ANAVEX®2-73 for the Treatment of Early Alzheimer’s Disease Together with Precision Medicine Genetic Biomarkers
Stephen Macfarlane, MBBS FRANZCP1, Michael Kornhauser BPharm1, Ella Modini BSc1, Harald Hampel, MD PhD2, Stephan Toutain MS3, Christopher Missling PhD3
1HammondCare Dementia Centre, NSW, Australia, 2Sorbonne University, Paris, France, 3Anavex Life Sciences Corp., New York, USA
Final program PDF can be downloaded here: http://www.ctad-alzheimer.com/program-0
Cheers man. I look forward to the day that my digging becomes obsolete. ;)
Thanks for your continued, top-notch, thoughtful analysis!
Thanks! I'm unsure about that, though. They don't comment on his progress or when he started treatment, but instead include these quotes which lead me to think he's recently enrolled:
Fixed - thanks!
More from Australia. Variation of same story, minus the Dr. Pittock profile, carried on a retirement focused site:
https://www.yourlifechoices.com.au/health/news/alzheimers-trial-delivers-results
Dr Pittock, among 2,000 climate scientists who shared the 2007 Nobel Peace Prize with former US vice-president Al Gore; an Anavex Alzheimer's clinical trial patient:
http://www.abc.net.au/news/2018-09-25/alzheimers-disease-research-questions-plaque-as-cause-of-disease/10299514
Anavex Life Sciences Corp. will be in attendance at The New York Academy Of Sciences day-long symposium, Neuro-Immunology: The Impact of Immune Function on Alzheimer's Disease, Tuesday, September 25.
https://www.nyas.org/events/2018/neuro-immunology-the-impact-of-immune-function-on-alzheimer-s-disease/?tab=attendees
And a reminder of the rest of the week:
Sept. 26 : CNS AND NEURODEGENERATIVE TARGETS - DISCOVERY ON TARGET - Boston, MA
1:50 Chairperson’s Remarks
- Daniel Klamer, PhD, MBA, Vice President, Business Development & Scientific Strategy, Anavex Life Sciences Corp.
1:55 ANAVEX 2-73, a Sigma-1 Receptor Agonist, in Phase IIb/III for the Treatment of Alzheimer’s Disease
- Daniel Klamer, PhD, MBA, Vice President, Business Development & Scientific Strategy, Anavex Life Sciences Corp.
Anavex Life Sciences Corp.’s lead drug candidate, ANAVEX 2-73, recently completed a successful Phase IIa clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that restores cellular homeostasis by activating the sigma-1 receptor. Full genomic analysis of the study participants resulted in the identification of genetic mutations linked to treatment response. Clinical studies in several indications are planned or underway utilizing a precision medicine approach.
http://www.discoveryontarget.com/CNS-Neurodegenerative-Targets/
5:05 Breakout Discussion Group: The Use of Precision Medicine in Drug Development for CNS Disorders
- Moderator: Daniel Klamer, PhD, MBA, Vice President, Business Development & Scientific Strategy, Anavex Life Sciences Corp.
• What questions should be asked before adding a new biomarker to your clinical trial?
• What lessons can we learn from oncology?
• Pros and cons using biomarkers as surrogate endpoints
https://www.discoveryontarget.com/breakout-discussions
--------
Sept. 27 : NON-OPIOD PAIN DRUG DEVELOPMENT SUMMIT - Boston, MA
2:30 Case Study: ANAVEX®1066, a Sigma-1 Receptor Antagonist, as a Therapeutic Candidate for Pain
- Daniel Klamer : VP, Business Development & Scientific Strategy, Anavex Life Sciences Corp.
• Strong scientific rational for the use of Sigma-1 Receptor antagonists in pain
• ANAVEX®1066 have demonstrated efficacy in several different pain models
• ANAVEX®1066 is safe in doses exceeding the observed efficacious ranges
http://www.non-opioiddrugdevelopment.com/
Ariana Pharma promoting their work with Anavex. Nice write up, including the further reading section where they point to the upcoming CTAD presentation and detail their full history of collaboration with Anavex.
http://www.arianapharma.com/2018/09/alzheimer-precision-medicine/
Clarification here. Time is from 3:30-3:45, NOT 3-3:45 (incidentally, directly following a presentation from Biogen; Aducanumab titration dosing regimen: 36-month analyses from PRIME, a Phase 1b study in patients with early Alzheimer’s disease).
Apologies for the error — was a bit too eager to get the post up.
CTAD Late Breaker Oral Communications Update!
10/26, 3-3:45pm - Longitudinal 148-Week Extension Study for ANAVEX®2-73 Phase 2a Alzheimer’s Disease Demonstrates Maintained Activities of Daily Living Score (ADCS-ADL) and Reduced Cognitive Decline (MMSE) for Patient Cohort on Higher Drug Concentration and Confirms Role of Patient Selection Biomarkers
Harald Hampel, MD, PhD1, Mohammad Afshar, MD, PhD2, Frédéric Parmentier, PhD2, Coralie Williams, MSc2, Adrien Etcheto, MSc2, Federico Goodsaid, PhD3, Christopher U Missling, PhD4; 1Department of Neurology, Sorbonne University, Paris, France, 2Ariana Pharma, Paris, France, 3Regulatory Pathfinders LLC, San Francisco, CA, 4Anavex Life Sciences Corp., New York, NY
http://www.ctad-alzheimer.com/files/files/Late%20call%20for%20abstracts.docx.pdf
It's a program mistake. The title of his session was:
"ANAVEX®2-73, a Sigma-1 Receptor Agonist, and Clinical Alzheimer Disease Drug Candidate: A Small Molecule with a Wide Scope"
Nell Rebowe of Anavex is a member of the Scientific Organizing Committee for an upcoming New York Academy of Sciences one-day symposium; Alzheimer's Disease Therapeutics: Alternatives to Amyloid, to be held on Dec. 11. Other members of the committee include Dr. Rudy Tanzi, co-discoverer of three of the first Alzheimer's disease genes and one of the most well known Alzheimer's Disease researchers in the world as well as Dr. Howard Fillit, Founding Executive Director and Chief Science Officer of the Alzheimer's Drug Discovery Foundation.
Symposium description:
Does Wayne State’s testing of Anavex 2-73 in Multiple Sclerosis continue?
At ECTRIMS 2018 (Oct 10-12), Dr. Lisak, his team at Wayne State, and scientists from UPenn will be presenting a poster titled: “Sigma 1 receptor and melanocortin receptor agonists protect oligodendroglia from death induced by products of B cells from multiple sclerosis patients”
There is currently no indication that 2-73 will be the (one of?) Sigma-1 receptor agonist(s) discussed. But with the results of last year’s poster covering both dextromethorphan and 2-73 leading Lisak to conclude that “A unique feature of ANAVEX®2-73, compared to another sigma-1 receptor agonist we studied, is that ANAVEX®2-73 accelerates the maturation of oligodendrocyte precursor cells (OPC) to oligodendrocytes (OL)”, it’s possible that this poster represents continued work with Anavex’s molecule.
We should know on Sept. 26th when the complete abstract is published.
Poster Session 1 here: http://www.professionalabstracts.com/ectrims2018/iplanner/#/grid
Or pg. 32 here: https://www.professionalabstracts.com/ectrims2018/programme-ectrims2018.pdf
Anavex's PDD trial recruitment video. En español:
http://pddtrial.com/
Excellent find brichnyc! CMC stands for "Chemistry, Manufacturing and Controls".
Another video put out by Neurology Live featuring Dr. Hampel:
Nice to note - The ICM Institute along with Sorbonne University have issued their own PR covering the recent Anavex news: https://toute-la.veille-acteurs-sante.fr/103041/emprunter-les-pistes-faites-sur-le-cancer-afin-de-trouver-un-traitement-contre-la-maladie-dalzheimer-communique/
Thanks for this tradeherpete! One correction is that in his last statement he is referring to The Alzheimer's Precision Medicine Initiative (APMI).
July 31: NDD Neuropsychiatric Drug Development Summit - Boston, MA
Panel Discussion: What are the Right Kinds of End Points, Where There Aren’t Any Approved?
Michael Palfreyman - Chief Scientific Officer, Amorsa Therapeutics
Christopher Missling - Chief Executive Officer, Anavex Life Sciences
Eva Kohegyi - Senior Director, Global Clinical Development CNS, Otsuka
Synopsis
• Exploring areas where endpoints haven’t been approved and understanding why this is
• Discussing the benefits and disadvantages of hard and soft endpoints in neuropsychiatry
• Reviewing why certain endpoints haven’t been approved and how to overcome this
Delving into Technology & Enablers, How They can be Used to Enhance & Transform Clinical Trials
Christopher Missling - Chief Executive Officer, Anavex Life Sciences
Synopsis
• Using early on Population PK, i.e. non-linear mixed effect (NLME) modelling an formal concept analysis (FCA)
• Include early on both RNA whole exome and DNA denome sequencing of patients
• Goal is to increase clinical success in pivotal studies
https://www.ndd-summit.com/about/agenda/
Nice to see Anavex included in this Axios write-up focused on the sense of optimism at AAIC. 2-73 and BAN2401 are the only drugs specifically mentioned:
https://www.axios.com/promising-results-in-alzheimers-research-a2b6826d-f446-4340-b6cc-5e18928fb042.html
Genomic analysis write-up provided by AAIC with quotes from Dr. Hampel about half-way down in this press release:
http://www.prnewswire.co.uk/news-releases/study-shows-intensive-blood-pressure-control-reduces-risk-of-mild-cognitive-impairment-mci-and-the-689108791.html
Thanks for this Talon — I tend to agree with you on this being a high probability scenario. Playing it out a bit further from a timing perspective:
In this first year of the ACTC program, the application deadlines were/are Feb 5, June 5, and October 5. Initially, I assumed they would have needed to target the June 5th date for application, but a quick review back to the February 7th Clinical Programs update from Anavex reveals:
Maybe not a monster press conference (and I've mentioned this before) but I like the fact that less than 1 week after the AAIC presentations, Dr. Missling will have some good stage time to expand on things with both an endpoints-based panel discussion and a half hour solo presentation covering the genomic analysis and other steps they've taken to increase the likelihood of clinical trial success. Not sure if we—as non-attendees—will hear anything out of this, but good to see the story being told further in the days immediately following AAIC.
July 31: NDD Neuropsychiatric Drug Development Summit - Boston, MA
I hadn’t seen this before and thought it was an interesting read — it’s a response/comments letter from ACT-AD to the FDA in regards to the Early Alzheimer’s Disease draft guidance issued in February. Anavex is a sponsor of ACT-AD and is among the organizations that signed the letter issued in May.
https://act-ad.org/app/uploads/2018/06/ACT-AD-Comments-on-FDA-2013-D-0077-05172018.pdf
On the topic of the lab behind the PET study, this video by the lead author of Anavex's poster and head of the Stanford lab, Frederick T. Chin, is great for anyone looking to learn a bit about PET radiopharmacy:
Cheers plex. I think there will be many more to share over the coming months.