Anavex Life Sciences Corp (AVXL)
BIO - aandeel onder andere in Alzheimer staat op ontploffen.
Mooie curve, nietwaar?
Ik heb dit aandeel sinds 2 weken en er is nog geen dag geweest dat het aandeel omlaag is gegaan. Waar ik nog veel meer van verwacht is Endonovo Therapeutics. Dit aandeel was vorige week even 100% hoger maar door een slechte beursdag sloot het maar 40% hoger.. Als de beurs volgende week weer opveert is er een grote kans dat er heel wat % bijkomen. Ik verwacht dat dit een van de beste aandelen wordt in 2016. AVXL staat bij mij op de 5e plek ongeveer. We gaan het volgende week in de gaten houden in dit topic. Ik zal wel een leuk artikel posten zo van avxl en ook van endv
Anavex Life Sciences (AVXL) stock popped nearly 30% after presenting some encouraging results from one of its Alzheimer's candidates. It's not uncommon for promising Alzheimer's results to move a stock. What makes the recent climb in Anavex shares so interesting is that it occurred in response to preclinical data observed in rats, from a drug that flies in the face of the prevailing thesis of how the disease could be treated. Anavex Life Sciences Corp. (AVXL) is dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex's lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept(R)), are currently in a Phase 2a clinical trial for Alzheimer's disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer's disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease.
Recently, Anavex Life Sciences (NASDAQ:AVXL) stock popped nearly 30% after presenting some encouraging results from one of its Alzheimer's candidates. It's not uncommon for promising Alzheimer's results to move a stock. What makes the recent climb in Anavex shares so interesting is that it occurred in response to preclinical data observed in rats, from a drug that flies in the face of the prevailing thesis of how the disease could be treated.
Over the past decade, at least 99% of Alzheimer's drug candidates that began clinical testing have failed. The ones that exist now, such as Aricept, can alleviate symptoms for a while but fail to slow the rate of cognitive decline. America will spend some $226 billion this year caring for sufferers of the disease, and an aging population is accelerating spending. Without any disease-modifying drugs available, the first to market will almost certainly become a multibillion-dollar blockbuster.
With so much to be gained, it's easy to see how minor developments -- such as presentations of preclinical data without any mention of working with regulators to make it available for clinical testing -- can move a stock. Small-cap biotechs without revenue streams, such as Anavex, are prone to wild price swings on data that would barely move the needle for larger companies with Alzheimer's candidates, such as Eli Lilly and Biogen.
AVXL Market Cap Chart
In the past year alone, Anavex shareholders have seen their investments rise more than 800%, only to fall about 80% since October. That's not to say stock prices of bigger drugmakers aren't susceptible to positive or negative data, but the swings aren't nearly as pronounced.
Although the latest price swing for Anavex occurred in response to a preclinical stage program, the company's lead Alzheimer's candidate, 2-73, has produced some compelling results in clinical trials. Let's compare Anavex's program with those of its gargantuan rivals and see if it's worth the tremendous risk.
Glimmers of hope
With so much on the line, you might think we'd know what causes the disease, but we don't. The most popular notion is that amyloid plaques consistently found in the brains of Alzheimer's patients cause the disease. Both Eli Lilly with solanezumab and Biogen with aducanumab have shown they can affect the formation of such plaques. But proving they slow the rate of cognitive decline is another matter.
A few years back, Eli Lilly's solanezumab failed to reach its goals in two large and expensive phase 3 trials. However, among mildly affected patients, some measurements showed improvements that were just strong enough to be considered statistically significant.
With so much to be gained if successful, Eli Lilly isn't giving up on solanezumab. A third phase 3 trial with over 1,000 patients is under way, and top-line results are expected next October.
More recently, Biogen's aducanumab showed a great deal of promise in a 166-patient phase 1 study this spring. The highest of three doses studied fired on all cylinders, showing a significantly reduced rate of cognitive decline and amyloid plaque formation. However, there were some safety issues involving brain swelling. This outcome pinned hopes to a smaller dosage that, a couple of months later, produced surprisingly weak results with regard to cognitive decline, and only a slight safety improvement.
With 166 patients split into four dosage arms and a placebo control group, a couple of outliers could be clouding our picture of aducanumab. We'll know more in early 2020, when the company expects to report top-line results of two ongoing phase 3 trials involving 2,700 patients.
A competing theory, championed by Anavex Life Sciences, suggests activation of sigma-1 receptors with its lead candidate, 2-73, leads to a "broad range of modulatory effects" that collectively act to reverse memory loss and protect neurons.
While I'd prefer a well-defined mechanism of action, this wouldn't be the first drug to succeed despite a fuzzy understanding of how it actually works. Also troubling is the surprisingly small amount of clinical data for a candidate that has been under investigation for at least eight years.
Although the main goal of phase 1 studies is to find a safe dosage, that doesn't mean you can't glean some efficacy hints in the process. In stark contrast to Biogen's phase 1 study of aducanumab, Anavex didn't include Alzheimer's patients in the first clinical study of 2-73 and instead opted to enroll 22 healthy white men between 18 and 55 years old.
But a phase 2 study started last December has given us very little to chew on as well. The 36-day first half of the trial expects to treat 32 mild-to-moderate Alzheimer's patients, and in November the company reported data from just 12. Patients showed a significantly improved response to stimulus as measured by the P300 wave. Making comparisons at this stage is next to impossible, as this measurement hasn't been reported for solanezumab, aducanumab, or any other Alzheimer's candidate I can find.
We shouldn't need to wait much longer to know how well Anavex's candidate stacks up to Biogen's and Lilly's. According to clinicaltrials.gov, full results of the phase 2a trial, including 52-week data with cognitive measurements used by Lilly and Biogen, should be ready this month, although the company hasn't announced a date to present them.
If 2-73 is shown to slow the rate of cognitive decline more effectively than solanezumab or aducanumab, Anavex investors can expect terrific gains. If not, however, a complete lack of clinical-stage candidates to fall back on could result in heavy losses. With the extremely limited clinical data to base a decision on, it's hardly worth the risk.
Hier het artikel over Endonovo seekingalpha.com/article/3238916-why-...
De foto`s in dit artikel tonen dat d.m.v TVEMF stimulatie, het stuk weggehaalde bot bij een konijn bijna helemaal weer is terug gegroeid. Ze vermoeden dat dit regenereer systeem ook op lever en andere organen kan werken.
Alles weer braafjes hoger. Je kan tegenwoordig beter in de USA beleggen dan de AEniks. Die daalt alleen maar.
Avanex gaat een belangrijk kwartaal beleven.
Een mogelijke partnerschap (met Biogen in MS) afsluiten en als het goed gaat drie fase 2 studies beginnen.
Ik heb een middelgrote positie in dit zeer speculatieve aandeel.
De werking van ANAVEX 2-73 is niet goed te verklaren en dat maakt me huiverig voor dit bedrijf/aandeel. Daarnaast is het kerngebied van Anavex zenuwziektes met als voornaamste kandidaat Alzheimer. Daar het overgrote deel van de middelen tegen Alzheimer faalt in fase 3 of veel eerder, is de kans van de Anavex middelen navenant?!?
We zullen zien, de CEO is vol optimisme :)
Nog een laatste pluk bijgekocht op $4.31.
Zeer, zeer risicovol. Maar bij succes is "the sky the limit".
Zaterdag 4 november presenteert Anavex de PK/PD data van Anavex 2-73 op de CTAD: www.ctad-alzheimer.com/poster-present...
I would say that 100% of drugs that targeted amyloid plaque failed. To my knowledge, none of the 4 drugs approved by the FDA for AD targeted amyloid plaque.
As has been posted before, 99.6% of all drugs tested for AD have failed. This means that 0.4% of these drugs were successful and were FDA approved. According to Missling and others, only 4 drugs have ever been approved by the FDA for AD. So 4 drugs represents 0.4% of all drugs tested. This means that only about 1000 drugs have been tested. It has also been posted a number of times that only 2% of incepted compounds made it to P3. So, 2% of 1000 is 20 compounds that made it to P3. Of these 20 compounds, 4 were FDA approved. This is an approval percentage of 20% for those drugs that made it to P3.
Het wordt druk de komende weken:
Quote:October 15, Wayne state abstract
October 25, Oktoberinvestfest presentation in NYC
October 27 Wayne state presentation on 273 MS results
October 30 The Parkinson's and Disease Therapeutics Conference
November 4 CTAD presentation in Boston on 273 alz study
November 13 Neuroscience 2017 presentation on 273 for Rett
November 14 Neuroscience 2017 presentation on 273 for Parkinsons
November 15 Neuroscience 2017 presentation on 273 for Anglemans syndrome
Start of Rett Trial - before year-end
Start of Alz trial - before year-end
Start of Parkinsons trial - before year-end
Gisteren presenteerde Anavex op de CTAD.
Data analysis demonstrates:
- Patients with highest ANAVEX®2-73 concentrations had improved cognition and function during 57 weeks and retained response at 109 weeks in the first anniversary of the long-term extension cohort Phase 2a study (ANAVEX®2-73-003)
- Continued favorable safety and tolerability through 109 weeks. ANAVEX2-73 administration does not prolong QTc interval
- Alzheimer’s patients with milder disease stage (baseline MMSE >20) tended to respond better to ANAVEX®2-73 than patients with more advanced disease stage (baseline MMSE <20)
- No sex difference in the pharmacokinetics of ANAVEX®2-73 was observed
- Strong drug concentration/response relationship with apparent broad therapeutic window revealed for key Alzheimer’s disease trial endpoints cognition and function
- Data provides support to evaluate ANAVEX®2-73 in a focused Phase 2/3 study using the precision medicine paradigm, including DNA whole
exome, RNA expression and gut microbiome characterization
- Therapeutic benefit potential of sigma-1 receptor activation with ANAVEX®2-73. Further clinical studies in Rett syndrome and Parkinson’s disease under development utilizing the translational potential of precision medicine approach of ANAVEX®2-73.
We zullen zien. Het blijft een lange termijn belegging?!?
Markets Have Missed A Trick With Anavex Life Sciences Corp. (NASDAQ:AVXL)
Anavex Life Sciences Corp. (NASDAQ:AVXL) is a company that we’ve looked at on a number of occasions over the past twelve months and on each occasion we’ve had to put forward an argument for the company’s potential success against a backdrop of wider market negativity.
This is a company that – it seems – nobody within the biotechnology sector (except its shareholders, of course) wants to see succeed and this has two primary implications.
First, that against a backdrop of basically no news, the company has maintained a steady downside trend (i.e. despite no bad news, markets are selling off on it). Second, that we almost always see an under response to any positive development hitting press.
We’ve just seen an example of the latter scenario.
On November 4 (so, the Saturday just gone), Anavex management took the stage to present some as yet unreported data from its lead development program. We actually mentioned this presentation the last time we covered this stock, suggesting that it’s well worth watching as it should serve up a degree of insight into the likely path forward for the drug under investigation and – in turn – the potential for the drug eventually reaching markets in its target indication in the US.
The presentation was strong, the data positive, yet Anavex is trading down on its Monday morning open price.
The obvious interpretation here is that there’s an opportunity to pick up shares at a discount ahead of a return to pre-presentation pricing. Further, and as we’ve stated in the past, we like any dips in share price ahead of the pathway coming to a close (i.e. the drug reaching commercialization) as potential entry points.
So, what did we learn from the latest data?
For those new to this one, the company is developing a drug called ANAVEX2-73 as a potential therapy for patients with Alzheimer’s disease. Alzheimer’s is a tough indication to go after and most of the drugs that target this condition fail at some point along their respective development pathways – generally earlier rather than later.
The data we just saw, however, suggest that ANAVEX2-73 is at least going to make into the later stages of development. In any other indication, that’s not a big deal. IN Alzheimer’s it is.
As per the presentation, data from a phase IIa trial of the drug in 32 patients with mild-to-moderate Alzheimer’s served up a strong primary endpoint hit (with said endpoint rooted in safety and tolerability) and showed that the maximum dose given was tolerable in the patient population. We also learnt that, in the second stage of the study (an extension study), the investigators expanded the dosing to 52 weeks from 26 weeks at the request of patients and caregivers (a strong anecdotal efficacy signal) and that, against numerous exploratory secondary endpoints rooted in cognitive function, quality of life, all the sorts of things that Alzheimer’s has a degradative effect on, the drug served up some degree of improvement.
Bottom line: this data looks strong enough for the drug to advance into what would likely be a pivotal phase II/III in the Alzheimer’s population and to do so with a solid base of efficacy data behind it.
This is Alzheimer’s of course, and we can’t stress enough how difficult it is to get a treatment on shelves in this space. And that’s not because the FDA or its counterparts around the world are especially tough on this category of treatment, it’s that we still don’t really know what causes the disease and – by proxy – what we can do to fix it.
This means that, while this data seems to imply efficacy, we’ve got to keep in mind that it’s a relatively small study and there’s a long way to go in terms of patients dosed before the company will have enough data in hand to support an NDA.
With that said, it’s not often that companies even get this close, so that markets have essentially ignored the development is a surprise and – in our eyes – an opportunity.
Het wachten is op de nieuwe protocols van de FDA. Zodra die er zijn verwacht ik dat Missling de drie phase 2/3 studies voor Rett, Parkinson en Alzheimer aankondigt.
Voor mensen die houden van een hoog risico, maar van mogelijkerwijs een super rendement, koop een plukje Anavex.
The P2-A trial that began in 2014 was designed for safety, mtd and signs of efficacy from what I understand. They weren’t using precision medicine to select the patients, they were finding people with mild to moderate Alzheimer’s by the best methods available at the time. This was akin to the old style recruitment for an Alzheimer’s study.
Out of that somewhat random, compared to the new precision medicine, selection of applicants we got 6 super responders who changed the way we think of Alzheimer’s treatments. I say that because the Editor in Chief of the Alzheimer’s Journal, George Perry acknowledged as much. The others in the 32 person study have had varying results, not pushed forward into the light for us to examine as much. A lot of people are, I think, overly concerned about the others that may be doing pretty well. We don’t know for sure. 7 dropped out for reasons unknown but not related to the drug so we’re down to 25, still with 6 resuming daily activities. All 25 and their caregivers emphatically requesting to remain on A2-73. They feel better, they feel safe and they are happier than anyone could have imagined 3 years ago.
The overseer of the study, Professor Stephen Macfarlane, has clearly pointed out that this study was not powered to show efficacy and the great results were unexpected. Yet we have changed the way Alzheimers treatments are now looked at. Anavex has raised the bar.
Now after 2 years of results and advances in examining and understanding how 2-73 works, the selection process for the 2b/3 is about to begin. The FDA has re-written the rules for how the study will be run, I think with Anavex in mind, as it will be the first Alzheimer’s study to be conducted under the 21st Century Cures Act.
I hope and believe they have a good idea why the 6 SR’s improved the way they did and the new trial patients will have more in common with them than with the other 26 that began the P2/A. Plus the dosing regimen will be optimized for those that we already know respond very well to 2-73.
Sometime in the next 46 days history will be made and an Alzheimer’s disease trial study will have the best chance of success we’ve ever seen.
Eindelijk, de wetgeving waar Anavex op zat te wachten:
Vandaag ook de nieuwe CEO boodschap (wel heel toevallig!)
We all know someone living with Alzheimer’s disease, whether a beloved parent, grandparent, a lifelong friend, a favorite teacher, or a neighbor.
We also all understand the toll that Alzheimer’s disease can take on caregivers, who can struggle for years to care for their affected loved one as they are no longer able to operate with full mental faculties.
In addition, the economic burden of Alzheimer’s disease on the United States is projected to skyrocket from $307 billion to $1.5 trillion annually by 2050 according to University of Southern California researchers.
What we do not have is a viable solution to treat this devastating disease.
I came to Anavex®Life Sciences in 2013 with the thought that this could change. The Company’s science and research aim has always been, and continues to be, to find the cause of neurodegenerative diseases, not just the consequences.Anavex® believes Alzheimer’s disease may be manifested through protein misfolding in the brain, which could turn into chronic cell distress, where the brain is not able to fend off the protein misfolding that could accumulate over time. The very high correlation of Alzheimer’s with age speaks to the manifestation of some constant aggression and probably the domino effect of the protein misfolding.
Chronic distress in the brain may have many sources. It could be caused by genetic factors, anxiety, lack of regular sleep, lack of physical exercise and poor diet. For example, we know today that all the things that are bad for the heart are also bad for the brain, such as a bad diet filled with high levels of fatty acids and/or too much sugar. Hence, some physicians regard Alzheimer’s as a “diabetes Type III.” The chronic cell stress may eventually cause the aggregation of Abeta or Tau, which are found in many Alzheimer’s patients. Interestingly, our drugs don’t target Abeta or Tau directly, however, have shown to reduce them. Hence, our drugs might be addressing the cause of the disease.
We, at Anavex®, are driven to find a solution to the largest and fastest growing therapeutic area, Alzheimer’s disease. We are also engaged to continue developing novel drug candidates for the treatments of central nervous system (CNS) diseases, pain and various types of cancers. Our Company has made important advances in the past year – from presenting successful Phase 1 data for the Company’s lead drug candidate, ANAVEX®2-73, to intelligently structuring and enrolling a state-of-the-art adaptive Phase 2a clinical trial of ANAVEX®2-73 and its combination with donepezil (Aricept®), known as ANAVEX®PLUS, for the treatment of Alzheimer’s disease.
With strategic expansion of our team through strong appointments to management, the Scientific Advisory Board and the Board of Directors, Anavex® is growing and actively advancing its robust pipeline. I strive to achieve our Company’s goals in a financially sound manner that can lead to value creation for the Company’s stakeholders. I also strive to find a potential solution to those affected by Alzheimer’s disease.
If you have questions or would like additional information about Anavex®, please do not hesitate to contact our investor relations team.
Christopher U. Missling, PhD
President and Chief Executive Officer
Anavex heeft het de laatste manden slecht gedaan. Geen enkele van de beloofde trials is van start gegaan, de reden daartoe zijn onduidelijk.
De koers is dan ook naar beneden gegleden om het jaar te eindigen op $3.22.
Het jaar 2017 moet daarmee maar snel worden vergeten; op naar een hopelijk meer positief 2018.
FatCool schreef op 29 december 2017 22:37:
Geen enkele van de beloofde trials is van start gegaan, de reden daartoe zijn onduidelijk.
Voldoende signaal om dit aandeel dus niet te kopen!
Onbetrouwbaar management is altijd een rode lamp!
Zakt vandaag onder de 4 euro, koopmoment!
Tijd om deze in de gaten te houden !!!!!!!
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