Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Top line data should be announce by the end of June. Any delay past mid July would be of concern as the assumption should be that results are less than stellar and data needs massaging. My expectation is that Enough is known by Dr. M already and he is behaving as someone who is confident of positive outcomes. Obviously, just a semi-educated guess on my part as I only know what everybody else here knows and opinions are all over the map/calendar.
That is really something we can put on everybody's calendar because the trial has been enrolled the last patient and we now have to wait for the 14 days – 14 weeks, which is the duration of this study plus the times needed to for the independent research zero to build the results. And then we will update the data as a – in a public announcement the top-line data, which will be mid of 2020
Christopher Missling: So the upcoming quarter will be the announcement of top-line data after Phase 2 Parkinson’s disease dementia study. That is really something we can put on everybody's calendar because the trial has been enrolled the last patient and we now have to wait for the 14 days – 14 weeks, which is the duration of this study plus the times needed to for the independent research zero to build the results. And then we will update the data as a – in a public announcement the top-line data, which will be mid of 2020
...and the earth is flat.
Peeing into the wind, especially in a stormy day, will get you wet....
Thank you!
Anything new material information will have to be disclosed prior to the meeting. I expect News before market opens. How relevant the news will be is anybody’s guess.
ThanksTalon. He accomplished more than I was aware of.
Be safe and healthy.
...that is with the FDA.
Talon, Did Gottlieb accomplish anything meaningful during his much hyped and short lived tenure? Serious question.
I disagree with you. It is about basic communication to stake holders. It would take 30 minutes to craft a straight forward message.
No need to debate further. I am a staunch supporter of our CEO and continue to believe that he has done a tremendous job getting us to where we are now. Shareholder relations management not one of his strength but not as critical at this stage of development.
Stay healthy.
This is not about changing market conditions. It is about basic investor relations. It is not a big effort.
Xena, I don't believe this is about holding Anavex to any other company's standards. I agree with the poster that a brief email from the CEO letting us know that the company is holding up well, or not, under the circumstances is a simple and not too demanding task. It is called Investor Relations.
As I stated in a prior post, the pandemic is not going to alter the long-term result, the drug either works or it does not. However, this is a good opportunity for Dr. M. to reset expectations in regards to time line or to reassure investors if there is no change to already stated milestones. It is the least we should expect from our CEO, whom I believe has done a tremendous job otherwise.
Bio, for once I am in agreement with you. A word from the CEO letting us know how the pandemic is impacting the company, especially in regards to trials, would be good to have.
We know that the crisis should have no impact on the drug's performance. I can only speculate that it is having an impact on trial progress as it is having an impact in just anything else in how the world operates.
I do still believe that our patience will be rewarded.
That is your prerrogative.
TRY 273, 1, OR ANY OTHER DIGIT YOU WISH. HOPE YOU GET LUCKY!!
https://seekingalpha.com/article/4330580-anavex-2minus-72-and-neurological-disorders-possible-path-forward?utm_medium=email&utm_source=seeking_alpha&mail_subject=avxl-anavex-2-72-and-neurological-disorders-a-possible-path-forward&utm_campaign=rta-stock-article&utm_content=link-2
Anavex 2-72 And Neurological Disorders: A Possible Path Forward
Mar. 9, 2020 8:05 AM ET|12 comments | About: Anavex Life Sciences Corp. (AVXL)
Lane Simonian
Lane Simonian
Biotech, alternative energy
(642 followers)
Summary
Anavex 2-73 may be a peroxynitrite scavenger and as such may help in the treatment of various neurological conditions, including Rett syndrome, multiple sclerosis, and Alzheimer's disease.
Anavex 2-73 has enough cash to complete trials on Alzheimer's disease, Parkinson's disease dementia, and Rett syndrome.
Some investment in Anavex may be worth the limited risk.
Anavex (AVXL) has received some positive news this year that may portend bigger news in the months ahead. First, the FDA has fast tracked Anavex 2-73 for Rett syndrome. Second, a study suggests that Anavex 2-73 may be an effective drug for multiple sclerosis.
Rett syndrome is a genetic neurological disorder that almost always affects girls. It is included as part of the autism spectrum disorder. Those with Rett syndrome suffer from seizures, severe impairments in speech and gait, and repetitive hand movements. Rett is caused by a mutation in the MeCPT2 gene the upshot of which is an excessive amount of glutamate in the brain. Glutamate then triggers a pathway that leads hydrogen peroxide production and peroxynitrite formation. The key to treating Rett and other autism spectrum disorders may well involve the scavenging of peroxynitrite. For peroxynitrite via oxidation and nitration contributes to DNA damage, inflammation, mitochondrial dysfunction, and neuronal cell death in autism spectrum disorders (peroxynitrite in autism spectrum disorders).
While this has yet to be proved, it is possible that Anavex 2-73 may help those with Rett syndrome and other autism spectrum disorders by scavenging peroxynitrite.
A similar etiology may exist for multiple sclerosis. Once again glutamate excitotoxicity leads to DNA damage, inflammation, mitochondrial dysfunction, and neuronal cell death (glutamate excitotoxicity in multiple sclerosis, peroxynitrite in multiple sclerosis). A different set of neurons appears to be affected in Rett’s and multiple sclerosis, but the pathway and culprits appear to be the same.
In multiple sclerosis, oxidation and nitration damage oligodendrocytes and prevent their regeneration (oxidation and oligodendrocytes, nitration in a MS model). The harm done to oligodendrocytes inhibits the formation of myelin sheaths which disrupts communication between nerve cells and provokes an autoimmune response which results in further nerve damage. As a result of these processes, multiple sclerosis patients often experience severe fatigue, muscle weakness, pain, difficulties in walking, vision problems, and sometimes paralysis.
The conjecture is that peroxynitrite scavengers can be used to treat multiple sclerosis as well (inosine for multiple sclerosis).
In the recent study, Anavex 2-73 seems to limit the damage to oligodendrocytes and allows for the regeneration of oligodendrocytes (effects of Anavex 2-73). This suggests that the drug not only limits oxidative and nitrostative damage but also partially reverses this damage. Maybe it acts as a peroxynitrite scavenger in the case of multiple sclerosis just as it does (or may do) in the case of Rett syndrome.
From an investment perspective, Anavex is a company that requires considerable patience. Depending on how one looks at, its CEO Christopher Missling has either been unnecessarily slow and cautious in rolling out clinical trials for various neurological conditions (Rett syndrome, Parkinson’s disease dementia and Alzheimer’s disease) or he has been prudentially methodical. Whichever it is, there is enough money available to complete all of these trials. This critical point largely offsets concerns about the company's cash burn rate, of which the following analysis is fairly representative:
On this analysis of Anavex Life Sciences’ cash burn, we think its cash burn relative to its market cap was reassuring, while its increasing cash burn has us a bit worried. Even though we don’t think it has a problem with its cash burn, the analysis we’ve done in this article does suggest that shareholders should give some careful thought to the potential cost of raising more money in the future (financial analysis).
Within the next year we should find out if Anavex 2-73 effectively counteracts the damage done by oxidation and nitration in various neurological diseases. For those already invested in the company stay invested; for those not invested consider at least a small investment. And be sure to keep a close eye out for pre-result news and studies that yield additional clues as to just how effective Anavex 2-73 may be in treating a series of neurological conditions.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
Mc, the difference is, as far as we know, that dementia is not being passed on to others as viruses are.
Not a loss unless you need to sell. No different than paper gains from 2 to 6. Don’t you think?
We take it in the chin only if we need to sell. Otherwise, accumulate if you have the means.
Although 5.70 would still be smart, I meant 4.70, which is even smarter,
Yup, I am feeling very smart about picking up an additional 5k shares at 5.70.
Na, the only reason to replace Dr. M is because his hair still too long.
Picked up another 5k.
The proxy would not hint of anything that has not already been made public. My point is that there will be meaningful news before the ASM which will make for a fun and friendly meeting for management to tout their accomplishments. Proxy could also be amended. Just an opinion.
I don't recall receiving the proxy for annual meeting this early. Dr. M most be anxious to share. Expect very very good news:
ANAVEX LIFE SCIENCES CORP.
51 W 52nd Street, 7th Floor, New York, NY 10019
Dear Stockholder:
You are invited to attend the 2020 Annual Meeting of Stockholders of Anavex Life Sciences Corp. which will be held on Tuesday, April 7, 2020, 10:00 a.m., local time, at the offices of K&L Gates LLP, 599 Lexington Avenue, New York, NY 10022.
Details regarding the meeting and the business to be conducted are described in the accompanying proxy statement. The proxy statement contains information on matters to be voted upon at the 2020 Annual Meeting of Stockholders or any adjournments of that meeting. In addition to considering the matters described in the proxy statement, we will report on matters of interest to our stockholders.
Whether or not you plan to attend the meeting, we encourage you to vote as soon as possible to ensure that your shares are represented at the meeting. The proxy statement explains more about proxy voting, so please read it carefully. Please complete, date, sign and return the accompanying proxy in the enclosed envelope to ensure the presence of a quorum at the meeting. Even if you have voted by proxy, and you attend the meeting, you may, if you prefer, revoke your proxy and vote your shares in person. Please note, however, that if your shares are held of record by a broker, bank or other nominee and you wish to vote at the meeting, you will not be permitted to vote in person at the meeting unless you first obtain a legal proxy issued in your name from the record holder.
The proxy statement is dated February 20, 2020 and is expected to be first mailed to stockholders of Anavex Life Sciences Corp. on or about February 26, 2020. The Proxy Statement and 2019 Annual Report are available at http://www.viewproxy.com/Anavex/2020.
We look forward to your continued support.
Sincerely,
/s/ Christopher Missling, PhD.
Christopher Missling, PhD.
Chief Executive Officer and
Chairman of the Board of Directors
Up and down...really?
HORSEPUCKY: AVXL GOES UP FASTER THAN IT GOES DOWN.
TRUTH: THE AVXL PUMP AND DUMP CRASHED FROM $14.84 TO $3.16 IN TEN TRADING DAYS!!!!!
Jethro Tull:
Let us close our eyes
Outside their lives go on much faster
Oh, we won't give in
We'll keep living in the past
Oh, we won't give in
Let's go living in the past
Oh no, no we won't give in
Let's go living in the past
HOW CAN SOMETHING BE PHENOMENAL AND NOTHING ON THE MARKET CAN COME EVEN CLOSE TO THIS, WHILE SIMULTANEOUSLY STATING IF THE COMPANY THE COMPANY CAN PROVE THIS
BECAUSE NO OTHER DRUG OR REMEDY HAS SHOWN THE POSITIVE RESULTS THAT A-273 HAS SHOWN. STILL NEED TO COMPLETE THE PROCESS FOR IT TO BE ACCEPTED AS SUCH!!!!
Tom, your TA already covered all the bases. Not matter what happens you will get credit. Hopefully it will be on the high- side of your 3.75 to 8 range.
Fair. Just puzzled about your question since you have been posting here for a while, and appear to have invested.
In any case, we know what we know for now and it is all good. I personally expect to wake up some day to news that will propel the stock where it belongs, compared to other speculative biotechs that are backed up by the large funds and therefore tend to move upward with lesser news than we have already received from Anavex.
GTALongs
"OK, it is GREAT that AVXL has been going up (bout time), but anybody got an opinion as to why? or what the catalyst is?"
Uhm, could it be because more want to buy than willing to sell? Else, could it be because several trials are under way and the news has been nothing other than positive? Or, could it be just because T123, Fibonacci, paved the upward tracks and now we can travel them? I could go on but will wait for your opinion hoping to be enlightened.
Best wishes for speedy recovery and return to the board to do what you do best.
God bless.
The U.S. Food and Drug Administration (FDA) has granted fast track designation to Anavex 2-73 (blarcamesine) for the treatment of Rett syndrome.
Fast track designation is intended to accelerate the development and review of experimental therapies aimed at treating serious or life-threatening conditions, with potential to address an unmet medical need. This designation includes frequent interactions with the FDA, eligibility for accelerated approval, priority review, and rolling submission of a new drug application to accelerate regulatory review.
Anavex Life Sciences is developing Anavex 2-73.
“With no currently approved agents to treat Rett syndrome, patients and their physicians have an urgent need for new therapeutic options,” Christopher U. Missling, PhD, president and CEO of Anavex Life Sciences, said in a press release. “We view this FDA Fast Track designation as continued support that Anavex 2-73 (blarcamesine) has the potential to address this unmet need.”
Anavex 2-73 is an oral, small-molecule activator of the sigma-1 receptor (S1R), a protein that plays a key role in protein folding. By activating S1R, Anavex 2-73 is designed to reduce the buildup of toxic misfolded proteins in nerve cells, as well as brain inflammation, oxidative stress, and mitochondrial impairment.
While mitochondria are cell compartments responsible for producing energy in the body, oxidative stress refers to an overproduction of oxidant molecules, known as reactive oxygen species, relative to the levels of antioxidant defenses in the body.
The FDA’s decision to grant fast track status to Anavex 2-73 was based on preliminary data from a Phase 2 clinical trial, called RS-001 (NCT03758924), recently presented at the 6th Annual European Rett Syndrome Conference in Finland. The study is still recruiting patients in the U.S.
Early findings from the first six patients on daily Anavex 2-73 over seven weeks showed that treatment led to significant improvements in the overall ability to function, assessed by the Clinical Global Impression Scale- Improvement, and lessened symptom severity as assessed by the Rett Syndrome Behavior Questionnaire.
Treatment also lowered the levels of the neurotransmitter glutamate and raised the levels of another neurotransmitter called gamma-aminobutyric acid (GABA) in the blood.
Neutransmitters are molecules that allow nerve cells to communicate. Some make nerve cells more likely to fire an electrical signal and are considered excitatory (glutamate), while others make cells less likely to fire and are inhibitory (GABA). The balance between excitatory and inhibitory neural signals is the basis of communication between nerve cells in the brain, and is disrupted in patients with Rett.
RS-001 is one of three trials — with AVATAR (NCT03941444) in Australia and EXCELLENCE — that form Anavex’s Rett Syndrome program. EXCELLENCE will enroll participants in Australia, with additional clinical sites planned to open globally in the future. The study will compare Anavex 2-73 with a placebo.
Anavex is also exploring the therapy’s potential to treat Parkinson’s and Alzheimer’s and has received a U.S. patent (No. 10,426,754) covering treatment of Alzheimer’s with Anavex 2-73. More recently, the company received a second U.S. patent (No. 10,507,196) covering treatment of Rett syndrome, multiple sclerosis, Angelman syndrome, cerebral palsy, and autism spectrum disorders.
The therapy previously received orphan drug and rare pediatric disease designations from the FDA for treating Rett syndrome.
Joana Carvalho, PhD
Priceless.
Agree.
Not meaningless if in the sample being referenced the total student population is 200 (100%) and 50 is the total of students in the honors roll. If all 50 of the honor students went on to college, that represents 100% of that group or 25% of the total. 50 of the non-honors also made it to college which also represents 25% of the total, but only 33% of that group. In this case being in the honors group is statistically meaningful in regards to moving on to college.
Not having all the data points one can only speculate that being fast-tracked gives Anavex a higher chance of being approved or at minimum a path to faster approval.
Thanks TTT. Contributors like you encourage me to continue coming back to this MB. Wading through some of the junk postings can be a challenge but I believe most of the true investors, looking for meaningful (good or bad) info, have learned which posters to bypass.
We are closer than we ever been for this company to give us the “real” answer as to its long-term viability. Nothing is guaranteed but I am feeling very confident that our patience is soon to be rewarded. Your early findings just reinforce my belief.
Thanks again!
"Why no enrollment update for the 20 patient Rett trial? What is taking so long and why is the company not updating?"
From this morning cinical update:
To offer all participants access to ANAVEX®2-73 (blarcamesine) after completion of the ANAVEX®2-73 (blarcamesine) U.S. Phase 2 Rett syndrome study1 and the AVATAR Rett syndrome study2, 12-week and 48-week open-label extension studies, respectively were initiated. Currently 90% and 100% of eligible participants have continued into the corresponding extension studies.
The international EXCELLENCE Rett syndrome study of ANAVEX®2-73 (blarcamesine) in pediatric patients was approved by the Australian Human Research Ethics Committee and is scheduled to initiate early 2020.
Hopefully more clarity this afternoon.