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He said it during the Noble Capital Markets’ Thirteenth Annual Investor Conference presentation on 1/30/17. The "tip of the iceberg" statement starts around the 09:50 mark: http://noble.mediasite.com/mediasite/Play/2451c4d03e624780a689acb83b9ddbe81d
Here's a rough transcript:
Not a direct connection to Anavex, but of interest when considering a potential direction in Epilepsy. Annapurna Poduri, MD, MPH Assistant in Neurology at Boston Children's Hospital and Associate Professor of Neurology, Harvard Medical School will be giving this presentation at the 9th Annual Personalized and Precision Medicine Conference on October 16th:
Most definitely! There are plenty of recent examples of his/their work out there. I just wanted to include that note about the website before anyone jumps on the lack of recent info there. You know how folks are.
Some Sunday Morning DD odds & ends. Nothing earth shattering, but some observations made over the past week:
1. I think it is encouraging to see that Ariana Pharma's CEO, Mohammad Afshar, MD, PhD, is listed as an author for the CTAD poster. From a quick look at other Ariana papers/releases, his name doesn't always appear. Not just because of this, but I am inclined to think that this presentation and the work they have done on 2-73 will be viewed as a major accomplishment for their operation. Can't wait to see the CTAD poster.
2. Also listed on the CTAD poster description is Ene I Ette, PhD CEO of Anoixis Corp. I haven't seen mention of their involvement before. From their (pretty dated) website: "Services - We provide efficient and informative design and analysis of efficacy and safety studies, perform population pharmacokinetic modeling, population pharmacokinetic / pharmacodynamic modeling using pharmacometric knowledge discovery approaches, population modeling for dose selection, and clinical trial simulation. We design and analyze clinical pharmacology and biopharmaceutic studies, and provide strategy for knowledge-based drug development." http://www.anoixiscorp.com/
3. IF Biogen does in fact license the development of 2-73 in Multiple Sclerosis, I would not be surprised to see that research continue in conjunction with Wayne State University.
Wayne State, over the years has conducted research and run a number of trials for Biogen's Tysabri, originally developed in partnership with Elan and eventually sold fully to Biogen with ongoing royalties. Biogen is currently still funding 3 trials with the drug at Wayne State:
http://neurology.med.wayne.edu/funded-research.php
In addition to the ongoing relationship with one of Biogen's aging blockbuster MS treatments, Biogen also has recently granted the university money for research in Sickle Cell and Huntington's Disease. Though this is common practice, with funds coming into the university from multiple big pharma companies, I believe it is encouraging to see the existing relationship between BIIB and Wayne State researchers.
He had to cancel today's appearance:
Haha, no worries. I just posted a further clarification. At least anyone can now see the listing!
Just to clarify, the session is definitely still listed. Go to the link you provided:
http://www.professionalabstracts.com/ectrims2017/iplanner/#/grid
Then scroll down to Friday the 27th, and look at the row at 14:00. You'll see "Parallel Session 14: Remyelination: from biology to clinical trials". Click that and you will see a list. Go down to Session 238 and click that. There you will see:
238 - Sigma 1 receptor agonists as potential protective and reparative therapy in multiple sclerosis
R.P. Lisak, L. Nedelkoska, J.A. Benjmains Neurology, Wayne State University School of Medicine, Detroit, MI, United States
The complete abstract will be published on 15 October 2017.
Presentation is still listed. Session 238.
This is the poster that was presented at the Gordon Research Conference for Fragile X and Autism-Related Disorders, June 5-10, 2016 in Mount Snow, VT
http://www.anavex.com/anavex-announces-positive-preclinical-results-with-anavex-2-73-in-fragile-x-autism-related-disorders/
Also of note, under Transactions on the Noble site, they are listed to have provided Corporate Advisory for Anavex in October 2016.
https://noblecapitalmarkets.com/transactions-noble-lsp
This is an ongoing relationship, and I'd love to see what they have to say currently!
They did initiate coverage then:
http://www.prnewswire.com/news-releases/noble-capital-markets-initiates-research-coverage-on-anavex-life-sciences-corp-avxl-300403268.html
Issuing a full research report at the same time:
http://nobleresearch.com/reports/AVXL_20170206_9669.pdf
They also held a multi-day non-deal roadshow for Anavex back on April 12-13th.
From the Noble Capital Markets Research Feed:
No, it was Kara Murphy, co-leader of the Bain & Company Healthcare Private Equity team.
http://www.bain.com/publications/articles/kara-murphy-on-2017-pharma-investment-outlook-the-deal.aspx
Interesting post from another board:
Mildly amused skimming over some of the long ago discussed and debunked "DD" on Professor Macfarlane today. Thought it would be good to share some of his current/upcoming involvement in the Alzheimer's research community:
Professor Macfarlane will be speaking on "Current directions in Alzheimer’s clinical trials" and will be delivering closing comments at the RANZCP Faculty of Psychiatry of Old Age Conference 2017 in NZ on November 8-10. See last page of this PDF:
https://www.ranzcp.org/Files/Conference/FPOA-2017/FPOA-program-as-of-14-August.aspx
He is also slated to be a plenary speaker next June at the International Dementia Conference in Sydney, Australia.
https://www.dementiaconference.com/speakers/all-speakers
Seems to me that his reputation and standing are still well intact.
So yeah, not at all a "fact".
A bit of Epilepsy DD and conjecture:
I was recently trying to gain an understanding of current treatment discovery efforts in epilepsy and came across the work being done by the ILAE/AES Translational Task Force. Dr. French is a chair and Dr. Cole will be introducing a symposium update on their work at AES in December. Seeing that Anavex has consistently seemed to be at the forefront of cutting edge thought/approaches to drug development, the Task Force’s mission and 4 key initiatives seem like they would be an ideal roadmap for moving 2-73 forward in Epilepsy.
I’m particularly intrigued by the final initiative:
McMagyar, I posted this elsewhere today but it is relevant to this thought. I hadn't read this article from December of 2016 before and feel like Missling was making the case for broad adjunctive therapy here. He's speaking about Alzheimer's in specific but it's easy to see how this statement would apply in other indications. The article is on pg 11 of this PDF:
https://scrip.pharmamedtechbi.com/-/media/Supporting-Documents/Scrip-Issue-PDFs/2016/scrip_3833.pdf?la=en
Have to keep repeating the fact that we have no way of knowing of the existence of an IND until the company decides to disclose.
EDIT to add that jimmy667's post sums this non-issue up very well. Thanks!
The quotes from both write-ups were taken from this April 23, 2016 article:
http://www.heraldsun.com.au/news/alzheimers-disease-breakthrough-melbourne-drug-trial-achieves-amazing-results/news-story/d96671bc643b16d2694e85e0639fea3d
And I would guess that it was indeed the Rotary club that put them together.
On the topic of drumming up excitement, this quote from the Rotary Hawthorne eBulletin does seem to indicate that they are potentially putting some extra significance on this talk:
Anavex is listed to present again at this year's Ladenburg Thalmann 2017 Healthcare Conference on September 26th.
http://www.meetmax.com/sched/event_43291/~public/conference_companies.html?event_id=43291&bank_access=0
Oct 27th at MSParis2017 - 7th Joint ECTRIMS /ACTRIMS Meeting, Professors from Wayne State will be presenting "Sigma 1 Receptor Agonists as Potential Protective and Reparative Therapy in Multiple Sclerosis" during a session titled "Remyelination: from biology to clinical trials".
http://www.professionalabstracts.com/ectrims2017/iplanner/#/grid
The complete abstract will be published on 15 October 2017.
Also of potential interest, Biogen will be sponsoring a satellite symposium on the 25th, titled "Can real world evidence (RWE) deliver personalised medicine?"
Though no actual connection seen, it brings to mind the fact that Ariana Pharma has presented multiple posters over the past year showcasing their Real World Evidence data mining platform...
I hope that my posts on this topic are not interpreted as "exulting". I have been merely trying to provide a fact based record of the company's usage of the term as a proposed MOA for 2-73. I do find it quite important to acknowledge and understand the shifts in theorization, and think that knowing of the inclusion and usage of such language is helpful toward understanding the direction of the company's translational research.
Thanks for that, but I am aware that the term itself is not new. What I was looking into was the first time that Anavex used it to describe the potential MOA of 2-73.
I believe the first time it was described this way by Missling was in his excellent The Wall Street Transcript interview on October 21, 2016: https://seekingalpha.com/filing/3258966
He states it again in this podcast on November 9th around the 00:02:40 mark: https://player.fm/series/health-and-well-being/dr-christopher-missling-president-and-ceo-of-anavex
Interestingly on November 6th, this article had already picked up on the usage, putting their own spin on it here: https://insiderfinancial.com/anavex-life-sciences-corp-nasdaqavxl-is-changing-the-game-in-alzheimers/118101/
And, finally, as I stated in a previous post, the first time it made it into a PR looks to be on November 22, 2016 in the 41 week, pre-CTAD PR: http://www.anavex.com/anavex-life-sciences-announces-data-on-41-week-treatment-of-anavex-2-73-for-patients-with-alzheimers-disease/
Actually, just realized you were asking when homeostasis was first used at all, not when it was stated as a fact of the MOA. I have a general idea of that from last fall, but will do some digging when I have time later and give a definitive answer then.
Glad to see you guys on this train of thought here. I was wondering the same thing last night and did some digging. It looks like the first time it was stated this way was November 22, 2016 in the 41 week, pre-CTAD PR:
http://www.anavex.com/anavex-life-sciences-announces-data-on-41-week-treatment-of-anavex-2-73-for-patients-with-alzheimers-disease/
Note, at the beginning of the PR, they use "targets homeostasis", but in the "About Anavex Life Sciences Corp." section toward the end of the PR it uses the absolute language: "ANAVEX 2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile."
I like that thought Talon. This is the PR on Anavex 1066 pre-clinical data presented last fall:
http://www.anavex.com/anavex-life-sciences-novel-sigma-1-sigma-2-ligand-shows-encouraging-results-as-an-analgesic-in-animal-models-of-neuropathic-and-visceral-pain/
Super minor news out of Australia. Prof. Macfarlane will be speaking in August about Anavex at the Rotary Club of Hawthorn:
http://www.hawthornrotary.org.au/speakers/9a4f4286-d9df-43f7-b2e1-b2051c023332
Note, the quotes pulled for the write-up are from this year old article:
http://www.heraldsun.com.au/news/alzheimers-disease-breakthrough-melbourne-drug-trial-achieves-amazing-results/news-story/d96671bc643b16d2694e85e0639fea3d
Good call. Back on March 15th, the presentation at the Oppenheimer Conference had it listed as just: "Phase 2a - Report PK/PD Data"
It's funny because in the midst of the swelling angst over corporate news of progress, participation in an investor event like this (with ~350 other companies) will invariably be looked at with a big "so what". I get it. But at the same time, the steadily growing Institutional investment numbers lead me to think that Dr. Missling's message is being heard within these venues.
Reminder. We have no way of knowing of the existence of an IND until the company decides to disclose.
CFR - Code of Federal Regulations Title 21
No. It's up to the company to disclose.
<< PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION
Subpart F--Miscellaneous
Sec. 312.130 Availability for public disclosure of data and information in an IND.
(a) The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.
(b) The availability for public disclosure of all data and information in an investigational new drug application for a new drug will be handled in accordance with the provisions established in 314.430 for the confidentiality of data and information in applications submitted in part 314. The availability for public disclosure of all data and information in an investigational new drug application for a biological product will be governed by the provisions of 601.50 and 601.51.
(c) Notwithstanding the provisions of 314.430, FDA shall disclose upon request to an individual to whom an investigational new drug has been given a copy of any IND safety report relating to the use in the individual.
(d) The availability of information required to be publicly disclosed for investigations involving an exception from informed consent under 50.24 of this chapter will be handled as follows: Persons wishing to request the publicly disclosable information in the IND that was required to be filed in Docket Number 95S-0158 in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, shall submit a request under the Freedom of Information Act. >>
That's been in the presentation pipeline charts since the Ladenburg Thalmann 2016 Healthcare Conference last September. When I noticed it after the presentation was published, I contacted Anavex IR to question the inclusion of the NIH logo and their response was:
"Thank you for your email and interest in Anavex Life Sciences Corp. (Nasdaq: AVXL).
In the epilepsy indication for ANAVEX 2-73, NIH repeated the preclinical experiment, which was confirmed with the same result.
Please do not hesitate to contact our office if we can be of further assistance.
On behalf of Anavex Life Sciences Corp.,
Investor Relations"