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AVXL will be reporting fiscal 4th qtr and year end results. Last year they reported on 12/30 -
http://www.anavex.com/2014/?post_type=news
That is one fantastic chart, Xena!!!
With all the time you've spent digging into AVXL, how come you don't know anything about the Company?
Oh, I get it. Lies fit your agenda.
I already discussed this but here goes again:
1. Fire Missling and replace him with a hedge fund guy, preferably Daivd Einhorn (on the board of the MJFF) or one of Einhorn's minions which is how Icahn operates. The attraction for Einhorn might be AVXL's science particularly in the area of PD. Or contact Icahn--he donates to several medical charities
Missling understands the science and was able to bring top level directors and scientific advisory members on board. I want a CEO that understands what he's in charge of, not some hedge fund figure head who knows nothing about the Company's science and looks foolish in front if conference attendees.
2. Delist AVXL from all European exchanges to weaken massive NSS.
The volume on the Euro exchanges is a pittance. Thinking there is massive naked shorting there is ridiculous.
and 3. Hire a first rate Manhattan law firm instead of paying outrageous CEO salary. (Einhorn might do it for free--after all he's worth at least $1.8 billion so what does he care about salary.)
Christopher Missling, PhD Director, President, Chief Executive Officer, Chief Financial Officer, Secretary, Treasurer. A CEO with Missling's background and responsibilities deserves at least what he is being compensated.
Others have mentioned contacting the FDA and/or the SEC (or even the FBI). Something might come of these efforts too particularly if we had a hard charging CEO
Contacting regulatory agencies does nothing. These criminal orchestrated short attacks have been going on since shorting has been allowed.
Stand behind our brilliant CEO and direct your vengeance towards the real culprits!
There's no way that shorting can bankrupt this Company. The trial results are already good enough to move to the next trial. $50,000,000 in funding is already available and there is plenty more available if needed.
A partnership could mean that no funding will be needed. Not even the available $50,000,000.
I think Missling did the right thing in trying to bring more eyes to the results. Macfarlane already revealed more about the excellent results in this interview -
http://seekingalpha.com/article/3672856-anavex-life-sciences-interview-with-dr-stephen-macfarlane?app=1&auth_param=15vcg6:1b44js1:24af926717ae311e732fa6d6ff053b99&uprof=46&dr=1
Anavex Life Sciences: Interview With Dr. Stephen Macfarlane
Nov 10 11:37 AM•Comment!
Disclosure: I am/we are long AVXL. (More...)
Anavex Life Sciences (OTCQX:AVXL) shares are down more than 30% today. The stock has seen an unprecedented drop since Friday. The reason for the sell-off is not clear. Based on Saturday's data, I am still positive about the science behind Anavex 2-73. I also had a chance to interview Dr. Stephen Macfarlane, who conducted the Phase 2a study. Dr. Macfarlane, who is the director of Aged Psychiatry at Alfred Health, has commented on the recent data. I will be providing further data to subscribers tomorrow.
AVXL is still one of the most profitable picks for me this year. However, I would recommend subscribers to consider their personal situation before considering to add to their positions during the current sell-off to bring down their average cost of acquisition. I opened a position in AVXL at $0.53 (pre-split) so despite the current sell-off, I am in green with the shares I am holding now. This is why I am continuing to hold despite the recent sell-off.
Below are my questions to Dr. Macfarlane and his responses.
1. what you think of the data in terms of efficacy
Whilst there is clearly a lot of interest in the cognitive data the study has generated thus far, I think people are losing sight of the fact that this was designed as a study to test safety, tolerability and bioavailability. Part A of the trial, if you examine the study flow chart, was extremely onerous for our participants, who had to attend daily for 12 days to receive study drug and pharmacokinetic sampling procedures that lasted several hours. They then had 12 days drug-free before the process was repeated. When designing the protocol the question was asked "what's in this for patients? They go through this onerous process, but have no chance to continue to receive the drug if they perceive benefit from it during Part A." Part B was thus added to the protocol partly to provide some incentive for volunteers to participate in the trial.
I think it's fair to say that we were not expecting such strong cognitive signals to emerge from a small n study that was not designed to capture statistical significance within the resultant cognitive dataset. To me it is very significant that all those who completed Part A elected to enrol in the 26 week extension, and as the first few patients began to return to the study sites for Part B visits we received the message from patients and carers that they wanted to continue on the study drug for longer, which prompted me to approach the sponsor to extend the study for a further 26 weeks.
To me, it was extremely encouraging to see any sign of a cognitive signal in a five-week study, and the strength of these signals was remarkable. I've been running Alzheimer's trials for over 16 years, and have never seen such a strong cognitive signal in any of the trials I've been involved in (including solanezumab). We've collected a number of verbatim quotes from study participants and their carers, which I'd be happy to provide to you in a deidentified form upon request.
2. are you satisfied that data presented at 5 weeks is any indication of results after a full-fledged 52 week study?
As above, to see a cognitive signal of such strength after only 5 weeks is truly remarkable. Only time will tell if these signals remain over the full 52 weeks, but participants will be undergoing cognitive evaluations at the 12, 24, 36 and 52-week time points, and we'd expect to report further on this data as it becomes available.
3. can you explain the various scores in the data, specifically where Anavex 2-73 showed promise, and
4. where it didn't.
Five out of the 6 cogstate domains showed improvement, with 3 of these showing large effect sizes. The 'one-back' test within cogitate showed an effect size of 1.1 (meaning the standard distribution curve of the results was improved by 1.1 standard deviations, a huge effect size. A published meta-analysis of donepezil's benefit on the same test showed an effect size of 0.28. The significance of this particular change is underlined by the fact that 75% of our sample had already been taking a stable dose of donepezil for at least three months, so the improvements on the Cogitate battery (and on all the other cognitive outcome measures, were achieved over and above the gains our participants might already have achieved through being on donepezil. The same is true for the improvements noted on MMSE and ADCS-ADL, and the EEG markers (of which one ERP was statistically significant). I gather much is being made in certain circles that the remainder of the EEG markers, as well as the MMSE and ADCS-ADL scores failed to achieve statistical significance, but in a 5-week study of 32 patients it would almost have been beyond belief if this were to have been shown to be the case. The study was not powered to demonstrate significance, but the response on certain outcome measures was so marked that significance was achieved anyway (at a level of p=0.001 in the case of the Cogitate one-back task.
5. Of all the battery of tests which do you think most powerful for AD, and how did Anavex 2-73 perform in that test?
The One-back test (which measures working memory, a key domain of impairment in AD) within the Cogstate battery is the most difficult test, yet showed the greatest improvement. This outcome is unlikely to have been an artefact of any placebo effect...when placebo effects occur they are typically larger for the easier tests. In addition, whilst placebo effects are common with CNS sedative drugs, they are less likely to be present in tests of drugs used to enhance cognition...individuals cannot anticipate, or 'imagine' what a better score would consist of, and are unable to produce improved results through mere 'wishful thinking.'
6. Can you compare these results with results from other AD trials in similar clinical stage?
A similar outcome in a trial such as this is unprecedented in my experience. I'd cite again the fact size of 1.1 for ANAVEX 2-73 on the Cogstate One-back test, and compare this to the published metaanalysis of donepezil's effect on the same test (0.28). Bear in mind, once again, that 75% of our subjects were already on a stable dose of donepezil for at least 3 months prior to baseline.
7. How would you compare this with Toyama's study? Are there critical differences between the two drugs?
As a clinician, I'm unfamiliar with the Toyama drug to any great extent, though I understand it's a pure sigma-1 receptor drug. ANAVEX 2-73 is different in that it targets both sigma-1 and cholinergic muscarinic receptors. The muscarinic activity is thought to underly the cognitive benefits of ANAVEX 2-73, with the sigma-1 component believed to reduce protein misfolding (including Abeta and Tau) and inflammation.
8. Do you think you will have even better results by adding donepezil to 2-73? Why? Are there plans to do that?
The population pharmacokinetic and pharmacodynamic analysis will reveal that, since we included both donepezil-treated (24/32) and donepezil-naive (8/32) patients in our trial. In other words, 75% of our sample have had ANAVEX 2-73 added to donepezil as part of the study protocol
Adam has a fantastic record of lying. That's about it.
“When several drug companies repeatedly see big stock price dips due to negative articles published at critical moments — especially when those dips benefit the financial interests of short sellers — it should raise serious questions at the SEC. Given the suspicious timing of Mr. Feuerstein’s articles, which include misinformation and innuendo, there should be an inquiry into whether there was a deliberate effort to manipulate the market for profit,” CREW Executive Director Melanie Sloan said.
Adam Feuerstein has been writing for the Street.com since 2001 and is marketed as their Senior Columnist although he has never attended journalism school nor does he have any formal education in Journalism. In fact, he has NO formal science background either (he was a political science major at Emory University) and thus his credibility and objectivity as a biotech journalist must be questioned. He has been sued by biotech companies for his one sided attacks . Additionally, his inaccurate reporting has even led to patient safety issues as outlined in this article about Oculus Innovative Sciences. There have been numerous articles written about his one sided tactics and his questionable timing and release of misleading headlines that can be found here. Under the guise of being a biotech journalist, Adam frequently writes misleading headlines and articles that are widely disseminated via the Street.com's media network. Our Website is devoted to biotech investors to voice their rebuttals and critiques of Adam 's one sided articles. So you are free to use any information on this site for personal or commercial purposes, modify it or redistribute as long as you keep a link back to ExposeAdam .com with the content. We are always looking for tips about Adam 's Past, his relationships with anyone on wall Street and any possible unethical or illegal activities he may be involved in. Got Something to expose about Adam ? Submit your tip here. Don't Forget to leave comments for us on the bottom of the page. We look forward to your contributions to our site.
Look back soon for our own version of Expose Adam 's Biotech Weekly which will tell the other side of the story to Adam 's Weekly column and rebut the erroneous one sided sell side slant he uses to hurt the retail investors. Additionally, we will be opening a message board soon to openly discuss biotech stocks and any and everything Adam Feuerstein.
I just put it in the comments section of the SA McFarlane interview. Hope some people read it.
Thanks bernardc,
Terrific interview!
Can you post a link?
I try to keep in mind what AVXL could be worth in a few years. 2-73 doesn't have to work nearly as good as it has so far in order to become the Standard of Care for Alz.
The road will be bumpy, but, there doesn't seem to be anything out there that has worked any where near as well as 2-73 so far.
Let's not lose sight of what we own!
From today's PR -
“While it is of prime importance to have confirmed that both the primary and secondary endpoints of the trial have been met, it is extremely encouraging to see the emergence of such strong cognitive signals after only 5 weeks of treatment. Such an outcome in a trial such as this is unprecedented in my experience, and the current results suggest that ANAVEX 2-73 could potentially make a significant difference in patients’ lives,” said Associate Professor Stephen Macfarlane, FRANZCP, Director of Aged Psychiatry at Alfred Health, who conducted the study. “We continue to receive extremely positive feedback about the effects of the drug from our study participants and their caregivers. The results justify a prospective comparison with current standard of care in a larger clinical trial.”
Professor Paul Maruff, Chief Scientific Officer of Cogstate commented: “The Cogstate tests measure people’s ability to store and use information. The results of the Phase 2a study demonstrate that ANAVEX 2-73 improves psychomotor function, attention and working memory. For attention and working memory these improvements were statistically significant with a p-value of p<0.05 and p<0.001, respectively and their magnitude clinically important. To my knowledge, we have not yet seen a drug that has improved quantitatively working memory to such an extent as seen with ANAVEX 2-73”.
Professor Harald Hampel, member of Anavex’s Scientific Advisory Board, and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, France, commented: “The collective data from this Phase 2a trial supports the concept of targeting the sigma-1 receptor with ANAVEX 2-73 with a degree of confidence that we did not foresee. Sigma-1 receptor presents an innovative interventional upstream approach to impact key cellular events believed to contribute to Alzheimer’s disease pathophysiology. The presented Phase 2a data underlines the importance of rigorously investigating a potential efficacy signal on co-primary outcomes such as cognition and function in larger and well-powered trials”.
“We are encouraged by the preliminary safety and efficacy data. We look forward to continuing with PART B of the Phase 2a trial and expect to provide data updates at 12 week, 26 week, 38 week and 52 week time points,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “While we remain focused on Alzheimer’s, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames.”
What makes you think shares were sold to LPC.
The O/S given out by the transfer agent last Friday makes it doubtful that shares were sold to them. If some were, it was a very small amount.
No promotion. AVXL up listed.
Drop caused by a coordinated short attack.
The last reported cash position was $13 million. The Company said they had enough cash for 2 years.
Of course, they would need more if they started another trial.
I don't think The Company sells to Lincoln Park unless they start another trial before partnering.
Yes, this good info from IR mentions the 100-300 patients for Phase 3 -
The Anavex laboratory was very active from the company’s inception in 2007 until a few years ago. The task of developing several promising compounds has been accomplished, one of which (ANAVEX 2-73) is now in a Phase 2a clinical trial. In the meantime, Anavex also in-licensed another promising compound, ANAVEX 3-71 (formerly AF710B), from a lab of the Weizmann Institute. The company’s focus has now shifted towards clinical development, which cannot be performed in the lab.
In terms of the number of participants in the Phase 2a trial, this is because of the adaptive design of the trial (versus a trial that includes patients receiving a placebo). Here is a summary of comments made by Dr. Tasos Zografidis, the Vice President Clinical Operations of Anavex, and Dr. Christopher Missling, President and CEO, in a conference call earlier this year, which provides additional insight into the reasons Anavex is using an adaptive trial design.
+++++
TZ: For background information, there are two approaches in a clinical trial. One is the placebo controlled study. Here you have to estimate the number of patients needed if you are testing a hypothesis since you need a certain power; you need a certain number of patients. However, the methodology that we are using is very different, we just measure whatever effect is there. If you measure the effect and are able to reproduce it mathematically (mathematical modeling), then you can calculate the number of patients needed so as to see the effect. By using the adaptive trial methodology with population PK modeling, we are implementing mathematical modeling along with probability density function statistical methodology. That means that the results are looked at in confidence intervals. In the first approach you first estimate the number of patients and then you "see" the effect. In the second approach you first measure the effect and then you calculate the patients needed so as to truly "see" the effect. So, these are two opposite approaches with same outcome.
CM: We want to get a signal and the adaptive clinical trial allows us to increase the dose or decrease the dose until we see a signal. The mathematical model that Tasos speaks of sufficiently allows us to measure the data from these 32 patients because we are measuring many data points in this trial, from blood samples and the various cognitive tests, which allows for sufficiently precise data to learn how the drug works in order to select the number of patients needed for a Phase 3 pivotal trial. The number could range anywhere from 100 to 300 and the goal is to figure that number out.
The key is to understand the difference between a statistical standard trial, which is based on the placebo versus active dose in a number of patients, and the adaptive trial design statistical method used. The FDA has written a very eloquent guideline which you can find on the fda.gov website (http://www.fda.gov/downloads/Drugs/Guidances/ucm201790.pdf). The FDA states that with the adaptive trial design, which we are using, you need fewer patients, you are able to do this in a shorter period of time, you are more likely to demonstrate the effect of the drug, and you are getting more information on the treatment effect as well as a better understanding of dose response information in subgroups. Lastly, you are able to identify and optimize the parameters needed for Phase 3 effects. So, this Phase 2a trial is a very important stepping stone and building block for a successful Phase 3 trial. We want to avoid the same failure that the other Alzheimer drug trials experienced, and by implementing a different, innovative trial design for ANAVEX-73 in Alzheimer’s treatment, we are leading a more efficient study than a conventional study.
I think other forms of dementia to start with. Someone posted all of the possible treatment applications from a patent or patent application. The list was looooong!
raja, I see you haven't lost sight of what we own.
Well done!
I try to keep in mind what AVXL could be worth in a few years. 2-73 doesn't have to work nearly as good as it has so far in order to become the Standard of Care for Alz.
The road will be bumpy, but, there doesn't seem to be anything out there that has worked any where near as well as 2-73 so far.
Let's not lose sight of what we own!
From today's PR -
“While it is of prime importance to have confirmed that both the primary and secondary endpoints of the trial have been met, it is extremely encouraging to see the emergence of such strong cognitive signals after only 5 weeks of treatment. Such an outcome in a trial such as this is unprecedented in my experience, and the current results suggest that ANAVEX 2-73 could potentially make a significant difference in patients’ lives,” said Associate Professor Stephen Macfarlane, FRANZCP, Director of Aged Psychiatry at Alfred Health, who conducted the study. “We continue to receive extremely positive feedback about the effects of the drug from our study participants and their caregivers. The results justify a prospective comparison with current standard of care in a larger clinical trial.”
Professor Paul Maruff, Chief Scientific Officer of Cogstate commented: “The Cogstate tests measure people’s ability to store and use information. The results of the Phase 2a study demonstrate that ANAVEX 2-73 improves psychomotor function, attention and working memory. For attention and working memory these improvements were statistically significant with a p-value of p<0.05 and p<0.001, respectively and their magnitude clinically important. To my knowledge, we have not yet seen a drug that has improved quantitatively working memory to such an extent as seen with ANAVEX 2-73”.
Professor Harald Hampel, member of Anavex’s Scientific Advisory Board, and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, France, commented: “The collective data from this Phase 2a trial supports the concept of targeting the sigma-1 receptor with ANAVEX 2-73 with a degree of confidence that we did not foresee. Sigma-1 receptor presents an innovative interventional upstream approach to impact key cellular events believed to contribute to Alzheimer’s disease pathophysiology. The presented Phase 2a data underlines the importance of rigorously investigating a potential efficacy signal on co-primary outcomes such as cognition and function in larger and well-powered trials”.
“We are encouraged by the preliminary safety and efficacy data. We look forward to continuing with PART B of the Phase 2a trial and expect to provide data updates at 12 week, 26 week, 38 week and 52 week time points,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “While we remain focused on Alzheimer’s, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames.”
I loved that notable scientists were quoted in today's PR -
Positive Safety Data, Statistically Significant Improvements on Exploratory Clinical Endpoints
NEW YORK, NY, November 9, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL). On Saturday, investigators presented positive safety and cognitive efficacy data for ANAVEX 2-73, the Company’s lead investigational oral treatment for Alzheimer’s disease targeting sigma-1 and muscarinic receptors, which are believed to reduce protein misfolding including reduction of beta amyloid, tau protein and inflammation at the international CTAD 2015 conference in Barcelona, Spain.
Initial analysis of 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 cognitive improvement across all doses in all exploratory cognitive measurements, including the Cogstate battery, Mini Mental State Examination (MMSE), event-related potentials (ERP) and P300 tests, which consistently demonstrated improvements from baseline in the completed PART A portion of the study in 32 mild-to-moderate Alzheimer’s patients. Even though PART A was designed as a 5 week bioavailability trial that included a built-in wash-out period of 12 days and without an optimized dosing regimen, several Cogstate tests demonstrated highly statistically significant improvements. This finding was supported by a trend towards improvement in median MMSE score, which increased by +1.5 over baseline at week 5.
Positive effects on cognition were further supported by highly statistically significant biomarker effects of treatment at week 5 on one event-related potential (ERP) measure with a p-value of p<0.0007 and improvement in the P300 signal. The ERP biomarker scores improved compared to the initial data presented at AAIC in Washington, DC in July 2015, by which time not all patients had yet completed PART A.
All patients who completed PART A volunteered to continue in the longitudinal PART B extension study.
In the interim analysis of the first 14 patients at week 12, the PART B portion of the study demonstrated a positive trend towards improvement over 12 weeks of ANAVEX 2-73 treatment on the secondary functional outcome measure, the Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL) by +3.21 points.
“While it is of prime importance to have confirmed that both the primary and secondary endpoints of the trial have been met, it is extremely encouraging to see the emergence of such strong cognitive signals after only 5 weeks of treatment. Such an outcome in a trial such as this is unprecedented in my experience, and the current results suggest that ANAVEX 2-73 could potentially make a significant difference in patients’ lives,” said Associate Professor Stephen Macfarlane, FRANZCP, Director of Aged Psychiatry at Alfred Health, who conducted the study. “We continue to receive extremely positive feedback about the effects of the drug from our study participants and their caregivers. The results justify a prospective comparison with current standard of care in a larger clinical trial.”
Professor Paul Maruff, Chief Scientific Officer of Cogstate commented: “The Cogstate tests measure people’s ability to store and use information. The results of the Phase 2a study demonstrate that ANAVEX 2-73 improves psychomotor function, attention and working memory. For attention and working memory these improvements were statistically significant with a p-value of p<0.05 and p<0.001, respectively and their magnitude clinically important. To my knowledge, we have not yet seen a drug that has improved quantitatively working memory to such an extent as seen with ANAVEX 2-73”.
Professor Harald Hampel, member of Anavex’s Scientific Advisory Board, and AXA Research Fund Chair at Sorbonne Universities’ Pierre and Marie Curie University (UPMC) in Paris, France, commented: “The collective data from this Phase 2a trial supports the concept of targeting the sigma-1 receptor with ANAVEX 2-73 with a degree of confidence that we did not foresee. Sigma-1 receptor presents an innovative interventional upstream approach to impact key cellular events believed to contribute to Alzheimer’s disease pathophysiology. The presented Phase 2a data underlines the importance of rigorously investigating a potential efficacy signal on co-primary outcomes such as cognition and function in larger and well-powered trials”.
“We are encouraged by the preliminary safety and efficacy data. We look forward to continuing with PART B of the Phase 2a trial and expect to provide data updates at 12 week, 26 week, 38 week and 52 week time points,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “While we remain focused on Alzheimer’s, the remarkably fast onset of clinical effect of ANAVEX 2-73 increases our options to potentially pursue additional indications for diseases characterized by working memory impairment and may enable clinical trials to be completed within shorter time frames.”
The presentation entitled “New Exploratory Alzheimer’s Drug ANAVEX 2-73: Assessment of Safety and Cognitive Performance in a Phase 2a Study in mild-to-moderate Alzheimer’s Patients” was presented by Professor Steve Macfarlane at CTAD in a late-breaking oral session and is available on the publications page of the Anavex website.
About the ANAVEX 2-73 Phase 2a Study
32 subjects who met NINCDS-ADRDA criteria for probable AD were recruited at five clinical sites in Melbourne, Australia. Subjects are between 55 and 85 years of age, and have a MMSE of 16 to 28. In PART A of the study, participants were administered ANAVEX 2-73 orally and IV in a randomized, open-label, 2-period, cross-over trial separated by a wash-out with adaptive study design lasting up to 36 days (5 weeks) for each participant. In PART B of the study, all participants are administered ANAVEX 2-73 daily orally.
At week 5 the MMSE score increased by +1.5 over baseline. The Cogstate Identification Task, Cogstate One Back Task and ERP Reaction Time all showed statistically significant improvements. In a preliminary interim readout of PART B data, ANAVEX 2-73 improved ADCS-ADL score, a functional measurement, over a period of 12 weeks by +3.21 over baseline, with 11 out of 14 (78.6%) patients improving. Both MMSE and ADCS-ADL are regulatory approved endpoints for pivotal Alzheimer’s disease trials.
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients enrolled 32 participants. It commenced in January 2015 and the participants, the majority of whom are also taking donepezil, have now completed PART A of the two-part trial. Lasting up to 36 days (5 weeks) for each patient, PART A was a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (ERP) were used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for a further 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers. PART B utilizes daily oral dosing in order to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of safety and tolerability of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints were dose response, bioavailability, and exploratory cognitive effects using electroencephalographic (EEG) activity and event-related potentials (ERP), Cogstate battery, Mini Mental State Examination (MMSE), and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADSC-ADL) as well as the exploration of ANAVEX 2-73 as a potential add-on therapy to donepezil, the current standard of care. The combination of ANAVEX 2-73 and donepezil (Aricept®) is known as ANAVEX PLUS.
Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
I'm riding it out.
Best possible news I could have hoped for.
"Anavex 2-73 Reverses Cognitive Deficits Measured by Standard ERP Methods at week 5"
Baseline - 5.99
Week 5 - 7.09
Healthy Control - 7.36
https://pbs.twimg.com/media/CTMsjZYWcAAZ6J5.jpg:large
REVERSES COGNITIVE DEFICITS in 5 weeks!!!
This is epic!!!
Get real. She hasn't stated anything that the trial data wouldn't back up.
Your posts this weekend make it obvious that you have sold and are now in panic mode.
Sounds like your family member is one of the "significant majority".
Cheers to that and welcome to the board!
Hey scott,
Check out the major holders of AXON. All of these holders should be aware of today's presentations by AVXL and AXON. They all know the enormity of the Alz market. Shouldn't be long before AVXL has a list of tutes like this.
http://finance.yahoo.com/q/mh?s=AXON+Major+Holders
The share price will run hard to the upside next week. Excellent data = no sellers. The share price has already corrected big time. Up we go.
The manipulators will try to attack the data just like they did on 7/22. The share price tripled on that data. We are now on the Nasdaq and institutions can step up and buy.
Very meaningful post by circa1762 -
We have statistically significant results (despite not powering the study for them) in three measures: ERP reaction time and two Cogstate measures. The other results are likewise beautiful regardless of statistical significance. I am fully satisfied the drug is working even after five weeks of suboptimal dosing.
My favorite slide is the P300/ERP targets slide with the percentage recoveries (66% of function recovered in reaction time, 80-some percent recovered in P300 and task accuracy, and 104% in false alarms). Just beautiful data...
"Anavex 2-73 Reverses Cognitive Deficits Measured by Standard ERP Methods at week 5"
Baseline - 5.99
Week 5 - 7.09
Healthy Control - 7.36
https://pbs.twimg.com/media/CTMsjZYWcAAZ6J5.jpg:large
REVERSES COGNITIVE DEFICITS in 5 weeks!!!
This is epic!!!
AVXL has finished their preclinical work. Their lab has been shut down. Clinical trials cannot be run in a lab.
Excellent!!! Thanks for putting that together wildcard235!
"Anavex 2-73 Reverses Cognitive Deficits Measured by Standard ERP Methods at week 5"
Baseline - 5.99
Week 5 - 7.09
Healthy Control - 7.36
https://pbs.twimg.com/media/CTMsjZYWcAAZ6J5.jpg:large
REVERSES COGNITIVE DEFICITS in 5 weeks!!!
Are you kidding me? How much better does it get?
Thanks for chiming in, doctor -
The data could not have been better. It will not take long for people to realize that. Next week is meaningless unless you sell. The science works and this thing will go to phase 3 with a partner sooner than people think. iMHO
Agree completely -
We have statistically significant results (despite not powering the study for them) in three measures: ERP reaction time and two Cogstate measures. The other results are likewise beautiful regardless of statistical significance. I am fully satisfied the drug is working even after five weeks of suboptimal dosing.
My favorite slide is the P300/ERP targets slide with the percentage recoveries (66% of function recovered in reaction time, 80-some percent recovered in P300 and task accuracy, and 104% in false alarms). Just beautiful data...
I figured AVXL would knock it out of the park!!!
Finally, we're at the point where the data will do the talking.
I have less anxiety this time around than pre-7/22 data release.
That data and everything I've read points to A-273 working superbly and having an excellent safety profile.
I predict that next week will be very enjoyable for longs!!!
GL LONGS!!!
Too much pre-presentation info. Just like the original presentation title.
The trial design doesn't include measurement of the MMSE score at 5 weeks, but, that doesn't mean that it wasn't taken.
This is an adaptive trial and AVXL, and those conducting the trial, may have wanted the 5 week interim info in order to determine dosage changes for the next patients.
I think the above is more likely than a typo.
Your "another interpretation" is exactly how I interpreted the abstracts. I'm looking forward to a great presentation Saturday.
I just bought again at 9.90
I bought after hours at 9.90.
The patients don't all improve the same amount, so, an average is used.
That's my take.