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Health See other Health Articles Title: Anavex as an anti-Alzheimers drug Stock Gumshoe analyzes investment potential of Alzheimers' drug stock (at link). Anavex Life Sciences (AVXLD on the OTCQX as of today, though it will begin trading on the Nasdaq tomorrow at AVXL), standard-bearer of the Alzheimer’s hopefuls in the junior biotech space for nearly a decade now. Following is the informative discussion by posters: MIke says:... Here is some DD on Anavex for your reading enjoyment. finance.yahoo.com/mbview/...11-49d3-8fa7-05586f439f62 Richard says: One can delay the onset of dementia by learning, a new language, playing high level chess, learning to lay a new musical instrument, doing crosswords puzzles, doing sodoku, not smoking, not drinking excessively. Donepezil is now off patent and should cost about $30 per month. The nun study indicates that on autopsies nun’s may have severe Alzheimer’s disease but not on cognitives tests done shortly before death. Drano says: That is incorrect. Although exercise does seem to help people with Alzheimer’s delay some of the degeneration, there are plenty of people who remained mentally active, exercised, ate right — and still got Alzheimer’s. Those studies claiming that learning new things delays onset have been discredited many times. Claiming that lifestyle can prevent or delay Alzheimer’s gets dangerously close to a “blame the victim” mentality. Having known several people who have gotten this horrible disease because of their genetics but had very healthy lifestyles, I find it offensive to see these unscientific untruths repeated — and, oddly enough, they are promoted by the very companies selling products that are supposed to help cognition in this bogus fashion. Some lifestyle issues do predispose one to Alzheimer’s. So do genetics. We can’t even diagnose Alzheimer’s well, we don’t know what causes it, nor how to treat it. AVXL’s drug seems to have helped some patients improve, and the fact that they rushed to be included in this conference certainly seems to indicate that they have some good results. There is currently NO good drug to treat this disease, perhaps because all of them focus on clearing out amyloid plaques. Some of the experimental drugs made the patients worse. A theory is that the plaques are like band-aids that the brain creates to try to fix the damage from Alzheimer’s, and the plaques are not themselves the cause but a symptom. AVXL’s drug is pursuing a completely different pathway — trying to get “upstream” so that the plaques do not form. Myron Martin says...: The question that doesn’t seem to get asked is, what has changed in our lifestyles, diets, environment etc.over the past 100 years or so that could be a “trigger” for the development of such horrible diseases as Alzheimers. I question whether the answer lies in some magical drug that will cure the disease as opposed, as most drugs do, merely controlling symptoms to some degree. Far too much money is spent looking for “cures” that can be treated at a profit as opposed to searching for CAUSES that can be prevented. I remember decades ago reading about researchers concluding that a major factor in Alzheimer’s being aluminum poisoning with fingers pointing at underarm deodorants containing aluminum and of course aluminum cooking utensils with numerous studies showing that certain acidic foods such as rhubarb cooked in aluminum pots would result in aluminum migrating into the food and this showed up in studies of Alzheimer’s patients brains, but that would be too simple an answer, avoiding certain poisons in out modern environment. Reminds me of the current controversy over prepared meats (bacon, sausages, wieners etc.) preserved with nitrates or nitrite being cancer causing. Immediately all kinds of industry affected producers are crying foul and trying to sway public opinion against the new research, and that seems to be the dilemma. Whenever “dollars” get involved threatening someones profits there is always a backlash to protect the status quo. How long did the tobacco companies fight the evidence that their product was deadly and how many millions of people are still hooked on the filthy habit? Human nature is our biggest enemy, most people either don’t take the time to educate themselves or plain just don’t want to know and continue unhealthy lifestyles. For the record, I knew more than 50 years ago that prepared meats (particularly preserved with nitrates) were unhealthy and gave them up. Our food should be eaten fresh, without preservatives, additives, anything artificial such as added colours and flavours etc. Patricia says...: BJI, has anyone bothered doing a comprehensive study comparing apples to apples: the RATE of dementia in those who reached advanced age in the past, to those who reach it now? Of course people are living longer – far fewer work accidents, fewer war deaths, less starvation and infectious disease, and the ability of doctors to do basic plumbing like bypass surgery. My own recall of people I’ve known is that far fewer of those who reached their 80s thirty or forty years ago developed dementias of any sort. Myron is correct – our poisoned environment and food supply is taking its toll. One proof is that the elderly among the few remote tribes who still live primitively, living off nature, tend to stay “sharp as a tack” mentally up until their last days, just like our own ancestors did. dcohn says:... Perlmutter claims it is based on diet.www.perlmutterfoundation.org/ Ponce says:... I read about a doctor whose very bright husband developed Alzheimer’s. After consultation with experts but no improvement, she did her own research and found virgin coconut oil as excellent food for the brain. The husband took at least 2 table spoons a day and in 37 days his symptoms was gone. The husband was able to go back working and made virgin coconut oil as his daily regimen. Of course no Pharma would be interested in this being a natural substance not patentable. sogiam says:... Different Brain Regions are Infected with Fungi in Alzheimer’s Disease www.nature.com/articles/srep15015 Best2ALL!-Ben Patricia says:... That was a great find Ben which I saw impressed even Dr. KSS. Cause or effect? I was once told about a personal remark by a surgeon to his patient that he found extreme parasite infestations in most of the cancer patients he operated on – if true, is that cause or effect? Why not both? I’ve seen some remarkable recoveries from serious illnesses in people who used herbs to kill their parasites, and in people who tried ketogenic diets (a diet which, in theory, would starve and kill fungi). If a body is being overwhelmed by a combination of four or five things, in my experience just fixing one of them can be enough to reverse the course of their health from succumbing to recovery. I doubt that any drug, or any natural substance, would have the power to reverse NFTs though – Alzheimers is likely one more of those degenerative conditions which they will eventually discover/realize/admit must be prevented or reversed in early stages, before so much structural damage is done. Gui_ says:... AVXL DD- All you need to know Anavex (AVXL) Here is some brief DD. Fully reporting OTC. Market Cap: Only $11 million and they are targeting indications with multi-billion potential Outstanding Shares: 56,441,000 Insider Ownership: 24.33% (Yahoo) Institutional Ownership: 54.39% (Figures from the Recent S1) Auriga Global 4.99% Auriga Investors-Montserrat 4.99% Hudson Bay Master Fund 4.99% DAFNA LifeScience LP 4.99% DAFNA LifeScience Market Neutral 2.53% DAFNA LifeScience Select L.P. 4.99% Joann Mostovoy 4.99% Sabby Healthcare 4.99% Sabby Volatility Warrant Master Fund 4.99% Sphera Global Healthcare Master Fund 9.99% HFR HE Sphera Global Healthcare Master Trust 1.95% Insider and institutional ownership give this stock a very small float which causes it to move quickly when she pops. Catalysts: They are target Alzheimer’s disease and other neurological disorders. Pre-clinical results have been astounding and there is huge promise for their molecules. They are currently running a P2A study, using a combination of Anavex. Data is expected in September 2015 or Q3. Also, they have utilized an “Adaptive Trial” design which will allow them to progress into a P3 study by the end of the year. CEO stated that in Q2 they will be filing an IND application to the FDA for an Orphan Indication. They also intend to provide an enrollment update in Q2 as well. The CEO’s presentation at the Roth conference can be found here: wsw.com/webcast/roth29/re...st/roth29/avxl/index.aspx Here is a summary of their pipeline. Of particular note is that their drug targets the multiple etiologies associated with Alzheimer’s disease including the Tau receptor, which the Mayo clinic just came out yesterday and said was the key driving force in Alzheimer’s. Here is the article: medicalxpress.com/news/20...s-reveals-tau-driver.html Our Pipeline Our pipeline includes one clinical drug candidate and several compounds in different stages of pre-clinical study. Our proprietary SIGMACEPTOR™ Discovery Platform produced small molecule drug candidates with unique modes of action, based on our understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, including Alzheimer’s disease. When bound by the appropriate ligands, sigma receptors influence the functioning of multiple biochemical signals that are involved in the pathogenesis (origin or development) of disease. Compounds that have been subjects of our research include the following: ANAVEX 2-73 ANAVEX 2-73 may offer a disease-modifying approach in Alzheimer’s disease (AD) by using ligands that activate sigma-1 receptors. In AD animal models, ANAVEX 2-73 has shown pharmacological, histological and behavioral evidence as a potential neuroprotective, anti-amnesic, anti-convulsive and anti-depressive therapeutic agent, due to its potent affinity to sigma-1 receptors and moderate affinities to M1-4 type muscarinic receptors. In addition, ANAVEX 2-73 has shown a potential dual mechanism which may impact both amyloid and tau pathology. In a transgenic AD animal model Tg2576 ANAVEX 2-73 induced a statistically significant neuroprotective effect against the development of oxidative stress in the mouse brain, as well as significantly increased the expression of functional and synaptic plasticity markers that is apparently amyloid-beta independent. It also statistically alleviated the learning and memory deficits developed over time in the animals, regardless of sex, both in terms of spatial working memory and long-term spatial reference memory. Based on the results of pre-clinical testing, we initiated and completed a Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73 in 2011. In this Phase 1 SAD trial, the maximum tolerated single dose was defined per protocol as 55-60 mg. This dose is above the equivalent dose shown to have positive effects in mouse models of AD. There were no significant changes in laboratory or electrocardiogram (ECG) parameters. ANAVEX 2-73 was well tolerated below the 55-60 mg dose with only mild adverse events in some subjects. Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including AD. The ANAVEX 2-73 Phase 1 SAD trial was conducted as a randomized, placebo-controlled study. Healthy male volunteers between the ages of 18 and 55 received single, ascending oral doses over the course of the trial. Study endpoints included safety and tolerability together with pharmacokinetic parameters. Pharmacokinetics includes the absorption and distribution of a drug, the rate at which a drug enters the blood and the duration of its effect, as well as chemical changes of the substance in the body. This study was conducted in Germany in collaboration with ABX-CRO, a clinical research organization that has conducted several Alzheimer’s disease studies, and the Technical University of Dresden. ANAVEX PLUS ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil (Aricept®) is a potential novel combination drug for Alzheimer’s disease. Aricept® (donepezil) is now generic. ANAVEX 2-73 showed in combination with donepezil an unexpected and clear synergic effect of memory improvement by up to 80% in animal models. A patent application was filed in the US for the combination of donepezil and ANAVEX 2-73 and if granted would give patent protection at least until 2033. In a humanized calibrated cortical network computer model the unexpected pre-clinical synergy between ANAVEX 2-73 and donepezil was confirmed and ANAVEX PLUS showed an anticipated ADAS-Cog response of 7 points at 12 weeks and 5.5 points at 26 weeks, which represents more than 2x the ADAS-Cog of donepezil alone. ANAVEX 3-71 ANAVEX 3-71, previously named AF710B is a preclinical drug candidate with a novel mechanism of action via sigma-1 receptor activation and M1 muscarinic allosteric modulation, which has shown to enhance neuroprotection and cognition in Alzheimer’s disease. ANAVEX 3-71 is a CNS-penetrable mono-therapy that bridges treatment of both cognitive impairments with disease modifications. It is highly effective in very small doses against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also has beneficial effects on inflammation and mitochondrial dysfunctions. ANAVEX 3-71 indicates extensive therapeutic advantages in Alzheimer’s and other protein-aggregation-related diseases given its ability to enhance neuroprotection and cognition via sigma-1 receptor activation and M1 muscarinic allosteric modulation. ANAVEX 1-41 ANAVEX 1-41 is a sigma-1 agonist. Pre-clinical tests revealed significant neuroprotective benefits (i.e., protects nerve cells from degeneration or death) through the modulation of endoplasmic reticulum, mitochondrial and oxidative stress, which damages and destroys cells and is believed by some scientists to be a primary cause of AD. In addition, in animal models, ANAVEX 1-41 prevented the expression of caspase-3, an enzyme that plays a key role in apoptosis (programmed cell death) and loss of cells in the hippocampus, the part of the brain that regulates learning, emotion and memory. These activities involve both muscarinic and sigma-1 receptor systems through a novel mechanism of action. They also have a very strong leadership team: Dr. Missling, President and CEO of Anavex, has over 20 years of healthcare industry experience within large pharmaceutical companies, the biotech industry and investment banking. Prior to joining Anavex, he served as the Chief Financial Officer of Curis and ImmunoGen. Dr. Zografidis, the Vice President Clinical Operations of Anavex, has over 25 years of experience in the pharmaceutical and healthcare industry, including 12 years at Wyeth (now Pfizer) in clinical project management and prior to joining Anavex most recently served as clinical and pharmaceutical consultant. Bernd Metzner, PhD, a director of Anavex, is currently Chief Financial Officer of the Doehler Group, a global producer and provider of technology-based natural ingredients for the food and beverage industry with sales activities in more than 130 countries. Previously, he was Chief Administration Officer and member of the Board of Management of Bayer Schering Pharma AG, the pharmaceutical division of $100+ billion market cap company Bayer AG. Solid pipeline and good leadership. They are also very good at PR, which is a benefit to shareholders in that they are actively trying to spread the word about their pipeline and potential. Here is a link to their corporate presentation: www.anavex.com/files/2015...orporate_Presentation.pdf Notice that on slide 24 the Market Caps of comparable companies. The LOWEST comparable it 10x’s larger than AVXL’s and they are at the same stage of development. Now here is the kicker, the recently completed and offering, underwritten by Maxim with 66 million warrants. 33 million of those warrants are exercisable at $.30 and the other 33 million are exercisable at $.42. Also, Maxim has a price target of $7 for AVXL. Do your own DD and you see the importance of this.” sogiam says:... NOURISH AD is a clinical research study evaluating the safety and effectiveness of an investigational drug for mild to moderate Alzheimer’s disease. Study volunteers will be monitored closely by their study doctor. www.ipsresearch.com/trials/accera-nourish-ad-study/ I believe this is the trial that is using palm and coconut oil extracts Best2ALL!-Ben sogiam says:... To go with above link: www.accerapharma.com/acce...nt-of-alzheimers-disease/ Best2U-Ben sogiam says:... ENZY- Enzymotec Ltd. Granted a New US Patent for Vayacog(R) in Pre-Dementia – See more at: globenewswire.com/news-re...html#sthash.121OjPNa.dpuf sheila225 says:... More confirmation of my earlier thoughts – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced the presentation of full PART A data and preliminary PART B data from the ongoing Phase 2a clinical trial of ANAVEX 2-73 at the upcoming Clinical Trials on Alzheimer’s Disease (CTAD) conference in Barcelona, Spain from November 5-7, 2015. The late-breaking oral session will be presented by the trial’s Principal Investigator, Stephen Macfarlane, FRANZCP, Director and Associate Professor, Aged Psychiatry at Caulfield Hospital in Melbourne, Australia. Lane Simonian says: Anavex’s drug has potential in that it is actually treating a pathway that is responsible for the progression of Alzheimer’s disease rather than supposed markers of the disease (amyloid oligomers, amyloid plaques, and tau tangles). The drug interferes with the chain between NMDA receptor activation and the formation of peroxynitrite (what the nun study showed is that you can have plenty amyloid and tau tangles in the brain and not have Alzheimer’s disease; the reason for this is that as long as peroxynitrite is being scavenged by antioxidants in the brain a person does not develop the disease). Peroxynitrite is an oxidant that limits the flow of blood in the brain, prevents the regeneration of neurons in the hippocampus, limits the synthesis and release of neurotransmitters required for short-term memory, sleep, mood, social recognition, and alertness, and leads to the death of neurons (it is peroxynitrite that leads to the activation of caspase-3 in Alzheimer’s disease). Inhibiting peroxynitrite formation is critical for slowing down the progression of Alzheimer’s disease. It is not clear at this point how thoroughly Anavex inhibits the formation of peroxynitrite nor is it clear if it does anything to reverse the damage that has already been done. At the very least, it should slow down the progression of Alzheimer’s disease, which is better than any current drug on the market, but not as good as some natural products that are peroxynitrite scavengers. onlinelibrary.wiley.com/d...79-8301.2009.00299.x/full www.ncbi.nlm.nih.gov/pubmed/19298205 www.ncbi.nlm.nih.gov/pubmed/22780999 www.ncbi.nlm.nih.gov/pmc/articles/PMC3659550/ stan says: alzhimers is a prion disease so is not curable Lane Simonian says:.... Alzheimer’s disease is not a prion disease. Ironicailly, amyloid plaques may prevent Alzheimer’s from becoming a prion disease, as they may sequester infectious prion proteins. www.ncbi.nlm.nih.gov/pubmed/17360589 But here is another important clue, ferulic acid–a peroxynitrite scavenger–can be potentially be used to treat a variety of neurodegenerative disease perhaps even including prion diseases. www.rsghb.cn/EN/abstract/abstract23047.shtml www.ncbi.nlm.nih.gov/pubmed/21272180 https://www.deepdyve.com/lp/elsevier/effects-of-ferulic-acid-and-angelica-archangelica-extract-feruguard-in-1JIk0sQm6J (Kanaya) armin says:... Anavex (AVXL): It´s so funny. As soon as anyone at any place in the WWW says anything different from “this drug will be the greatest drug of all time and will revolutionize medicine” there soon come some guys around the bush who are touting exactly this. This is the biggest stock promo and the biggest cult-like following for a stock I have ever seen since Uni-Pixel in 2012/13: bigcharts.marketwatch.com...=335&width=579&mocktick=1 Ultimately this will probably end in a desaster for stock holders. But the knack on that: As long as there are merely small shareholders and insiders (and no institutionals) in the stock (and that´s the case at the moment), the hype can go on for quite some time because they will interpret the November 7 results as they please, no matter what would be a realistic take on them. So it even could be possible for them to place a capital increase at a absurdly high price in the market as was the case with Uni-Pixel (UNXL). Stock market psychology seems not to have changed much since the tulip mania a few centuries ago: https://en.wikipedia.org/wiki/Tulip_mania Lane Simonian says:... Name: Anavex 2-73 Chemical Name: Tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanmethanamine hydrochloride The best antioxidants contain a methoxy group and a phenol group. That is what you need to partially reverse Alzheimer’s disease. But an antioxidant that slows down Alzheimer’s disease would still be a coup. Lane Simonian says:... Under different circumstances and at different doses, dimethylsulfoxide can act as either an antioxidant or as a prooxidant. I cannot find any direct studies regarding Alzheimer’s disease but here is one positive and one negative study relating to Alzheimer’s disease. www.ncbi.nlm.nih.gov/pubmed/20463302 connection.ebscohost.com/...-tau-hyperphosphorylation OFP says:... No one seems to be looking at their clinical data reported 7/22/16 with a critical eye. This is the data that supposedly shows 2-73 is “4x better than donepezil”. Let’s review… First, the measure reported was not a cognitive test. Instead, it was the P300, a type of event related potential that is expected to be a biomarker for cognition. The P300 has been shown in multiple studies to be have reduced amplitude and delayed latency in patients with Alzheimers. Some papers claim that a treatment effect from Alzheimers treatments can be followed with this measure and AVXL pointed to one in particular (Onofrj 2002) in which donepezil resulted in improvement in both amplitude and latency of the P300. On 7/22 AVXL reported that the P300 amplitudes in their 12 patients were increased compared to baseline though the differences were not statistically significant (no p value given). They compared the degree of P300 amplitude change (even though it was not proven to be even greater than baseline) as 3.8x that seen with donepezil in the Onofrj article. A dubious comparison to say the least but there is more…what was missing was any reference to the P300 latency. Later they showed the P300 grand averages in their corporate latency and from that there is NO DISCERNIBLE latency change from baseline. So in total there is a surrogate marker for cognition that has only one of the two expected changes in response to treatment and no statistically significant changes. IMO, comparisons to donepezil are highly premature but there was an absolute hysteria generated by these data. Post Comment Private Reply Ignore Thread
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