I agree. Yes, it's encouraging for Prana's imagine trial that there is a strong correlation with AD progression and that the FDA may take the reduced atrophy into consideration.
I am really hoping the there is cognition improvement that is both the initial target of the FDA to qualify for accelerated approval, in the MOA of Anavex 2-73, and a weak spot of donepezil.
National News 29/01/2015
World first 'brain pill' trial in Melbourne
A revolutionary Alzheimer's drug is being trialed for the first time in Victoria, with the trial leader calling it a "brain pill".
Lead researcher Professor Steve Macfarlane says the drug has a unique cognitive enhancing function.
"Not only should this drug slow the process down, but people will actually feel better and perform better," Professor Macfarlane said.
According to the professor, his unit at Alfred Health was "cold called" to be the first to research the drug.
The director of Aged Psychiatry at Caulfield Hospital said his department had trialled a dozen Alzheimer's drugs over the last six years.
The pill, Anavex 2-73, helps protect the brain and enables nerve cells to live longer.
It also assists with the removal of amyloid plaque, which builds up in the brains of those with the disease.
Title under the photo is very nice: Anavex 2-73 is designed to both halt the progression of Alzheimer's disease and improve sufferers' memory. (File photo)
First Austrailia Herald, then Today/Tonight who is only beginning to follow this trial, now Autrilia Broadcasting Corp. The current price in no way reflects the value of the milestones reached. A fundamental revaluation upward will occur at some point. I can't predict the timing but I chose to get in before it takes place.
Alzheimer's drug trial would be 'welcome' in south east NSW
By Alexandra Beech
Posted 57 minutes agoWed 28 Jan 2015, 1:00pm
Anavex 2-73 is designed to both halt the progression of Alzheimer's disease and improve sufferers' memory. (File photo) Photo: Anavex 2-73 is designed to both halt the progression of Alzheimer's disease and improve sufferers' memory. (File photo) (ABC News)
Map: Bega 2550
Alzheimer's Australia says the trial of a new drug is an exciting move for sufferers in south east New South Wales.
Anavex 2-73 is designed to both halt the progression of the disease and improve sufferers' memory.
It's now on trial on a small scale in Victoria.
If successful across the border, the next phase of the trial will extend to around Australia.
The southern NSW manager for Alzheimer's Australia, Barbara Williams, says she would welcome a trial of the drug in the Bega electorate.
"We're currently in the top five of NSW electorates for dementia prevalence," Ms Williams said.
"We've got approximately 1600 people living with dementia at the moment.
"By the year 2020 that's expected to grow to approximately 1900 and by 2050 it's going to be over 3500 people in our community."
She said the drug could help the region's dementia sufferers.
"Most current medications that are available tend to relieve the symptoms of dementia and Alzheimer's disease but they don't actually slow the progression of the disease itself," she said.
"This new drug, if it works, is forecast to both relieve the symptoms and slow the progression, which of course we would welcome for people living in the south east region."
A novel, potentially disease-modifying treatment for Alzheimer’s disease is set to begin a Phase 2a clinical trial, designed to evaluate efficacy over a time frame of 6 months, across 7 study sites in Australia. ANAVEX 2-73, a pipeline product of Anavex Life Sciences Corp., will be partnering with a leader in neurotech, Neuronetrix, for their proprietary COGNISION™ System, a neuro-electrophysiological device that allows objective assessments that can effectively quantify and analyze cognitive biomarkers in the study’s participants.
There are over 332,000 Alzheimer’s patients in Australia alone, and at least 44 million worldwide. There is still no known cure for this neurodegenerative disease, and today’s available treatments have only been successful with slowing disease progression. Without a breakthrough treatment soon, experts are expecting the number of Alzheimer’s patients to increase to 135 million worldwide by the year 2050.
This multi-site adaptive study will examine key performance measures in 32 patients with mild to moderate Alzheimer’s disease. With COGNISION’s help, Anavex’s researchers will have a more convenient, reliable means to study cognitive biomarkers through a cloud database.
“Due to COGNISION™’s cloud based structure, our systems are specifically designed to be used in multi-site clinical trials that require immediate data analysis,” said Dr. Marco Cecchi, Director of Research and Clinical Affairs, Neuronetrix. “We are excited to be a part of this important treatment study.”
Validation of hippocampus atrophy
Alzheimers Dement. 2015 Jan 22.
Relationship between hippocampal atrophy and neuropathology markers: A 7T MRI validation study of the EADC-ADNI Harmonized Hippocampal Segmentation Protocol.
Apostolova LG1, Zarow C2, Biado K3, Hurtz S4, Boccardi M5, Somme J6, Honarpisheh H7, Blanken AE8, Brook J9, Tung S3, Lo D3, Ng D3, Alger JR8, Vinters HV10, Bocchetta M11, Duvernoy H12, Jack CR Jr13, Frisoni G14; EADC-ADNI Working Group on the Harmonized Protocol for Manual Hippocampal Segmentation; EADC-ADNI Working Group on the Harmonized Protocol for Manual Hippocampal Segmentation.
The pathologic validation of European Alzheimer's Disease Consortium Alzheimer's Disease Neuroimaging Center Harmonized Hippocampal Segmentation Protocol (HarP).
Temporal lobes of nine Alzheimer's disease (AD) and seven cognitively normal subjects were scanned post-mortem at 7 Tesla. Hippocampal volumes were obtained with HarP. Six-micrometer-thick hippocampal slices were stained for amyloid beta (Aβ), tau, and cresyl violet. Hippocampal subfields were manually traced. Neuronal counts, Aβ, and tau burden for each hippocampal subfield were obtained.
We found significant correlations between hippocampal volume and Braak and Braak staging (ρ = -0.75, P = .001), tau (ρ = -0.53, P = .034), Aβ burden (ρ = -0.61, P = .012), and neuronal count (ρ = 0.77, P smaller than .001). Exploratory subfield-wise significant associations were found for Aβ in CA1 (ρ = -0.58, P = .019) and subiculum (ρ = -0.75, P = .001), tau in CA2 (ρ = -0.59, P = .016), and CA3 (ρ = -0.5, P = .047), and neuronal count in CA1 (ρ = 0.55, P = .028), CA3 (ρ = 0.65, P = .006), and CA4 (ρ = 0.76, P = .001).
The observed associations provide the pathological confirmation of hippocampal morphometry as a valid biomarker for AD and the pathologic va
From Prof. Stephen McFarland, if it works we're probably looking at 3 years from this point due to the possibility of acceleration to market.
The FDA draft guidelines suggested demonstrated cognitive improvement with a good safety profile would qualify a drug for Acceleration to market. They also are open to other surrogate biomarkers once proven, such as AB-42/plaque redcutions, Tau reduction, decreased hippocampus volume degeneration, eventually possibly even blood biomarker tests as they are proven out.
The nice thing on Anavex 2-73 is that because of the receptor it is acting on and animal model testing, it is cognition improvement that will likely be demonstrated.
AVXL is an 18 cent stock? And we should be a $2.00 stock. It is an attractive speculative buy at this level for sure. Any success whatsoever, and you can pick the point where you take out your cost basis and let the rest ride.
Here it is if allowed to post https://au.news.yahoo.com/video/watch/26128500/new-alzhemiers-drug-trial/
Today Tonight show coverage came out 5 hours ago - on youtube
The today/tonight show is the same new channel that ran a patient interview testimonial at the beginning of the follow-on open label extension of Prana Biotech's PBT2 Trial.
They are already on top of the Anavex 2-73 open label trial right out of the gait.
I can almost guarantee there will be a follow-on media piece. Where with Prana Biotech it could have been considered a foul because it was a double-blind trial, I think it was done just when the open label extension trial began dosing. Anevex's trial is an open lable trial.
Prana Biotech is an Aussie company with ADRs listed on U.S. exchange, so if there were fireworks on ASX, it would translate over into U.S. trading.
However, Anevex is an OTC and has more to overcome to gain visibility. For instance, this aussie news article is not even on the radar. They will overcome that to the extent that they put out newsire announcments.
Prana's announcement to distance itself from a testimonial newspiece had a hugely positive effect on the shareprice..
So far the news Anevex puts out are solid news on topic. I have no idea when we get on the radar, but for a phase IIa already dosing in a short trial also testing for efficacy signals we should be moving up eventually as the trial proceeds.
I saw a similar thing occur with Prana during their trial but it was a special news segment interview of a trial participant and his wife, but Prana's trial was a double-blind trial - somehow they interviewed a trial candidate claiming wondrous improvement on a special TV news segment. Prana had to distance itself from the news piece, but it was great for the shareprice.
Here, the trial is open label and I think there is less concern. They published the person's complete name!. I could easily see this person ending up in a news interview a month or so from now. This trial is also only half as long as Prana's, where following Part A that is completed within 36 days (about 20/21 days to go), the Part B is 26 weeks of additional daily oral dosing.
I suspect this will not be the last bit of publicity, but calling the time of the next news piece is nearly impossible. In my opinion, when first patient gets into part B of the trial it's fair game to see this individual and family member(s) appear in a special news segment giving a testimonial.
The following study recently came out, and it highlights that there is a need to use something with Donepezil (Aricept) that improves cognition.
Donepezil decreases hippocampus atrophy rate but does not improve cognition
Alzheimers Dement. 2015 Jan 14. pii: S1552-5260(14)02856-8. doi: 10.1016/j.jalz.2014.10.003. [Epub ahead of print]
Nice thoughts. As I understand it, currently the standalone version of the drug in P2a trial is Anavex-23, and the compound in combination with Donepezil/Aricept is called Anevex-Plus. Under a partnership it would make sense to be flexible and do some type of branding with the recognized name. I suppose terms would dictate all else.
The trend in the AD testing field that is a bit controversial, but big pharma is pushing it is the use of cocktails, or combinations of drugs in trials. I think this bodes well for any upstream, novel, easily administered drugs.
As far as counting chickens before they, buying the chicken costs a lot more than buying the egg. That's what investing is all about. Sure, someone buying in after a partnership announcement could make a lot of money, but anyone holding a position before the announcement will have already made a lot.
I was talking about paragraph 2 of the medical findings, but take your pick...
This could be a $5 to $10 stock. Not saying it will happen overnight, but folks this is as basement floor as it gets. This is a very novel approach, and a very promising approach to a beneficial outcome, with a great safety profile, and something that may be beneficial in multiple CNS disorders, such as ALS, schitzophrenia, etc.
What would a partnership announcement at some point during this open label extension mean to the stockprice of an .18 stock? Completely running under the radar...