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I somewhat share your patent concerns; however, even if 2-73 was patent protected for 17 years, a competitor could (would) tweak the formulation a bit and submit for their own patent.
In either case, it will still take quite a while for a competitor to go through the entire in vitro and in vivo trials before ever being approved. Seems it would also have to show as being equal to or better than SoC (2-73). All the while 3-71 is already in the trial pipeline.
There is a big advantage to being first.
Perhaps more shaking until the PR is released. Then serious buyers should come in force.
Love the short covering into the close. Nobody wants to hold short over the weekend when a PR could come at any time.
Anavex is not exhibiting; they are presenting in two poster sessions.
Late-breaking could still very well happen...and I believe it will. See below...
An individual may be the presenting author on one oral presentation (includes a featured research session) and two posters slotted on different days.
Certainly not negative. A company doesn't schedule TWO poster presentations to present so-so results.
If Anavex indeed has the drug, I would think it's certainly worthy of a late-breaking oral presentation.
Below is the most recent patent application update by Anavex on June 9. I cannot tell if this is for 2-73 or 3-71.
http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PG01&s1=Anavex&OS=Anavex&RS=Anavex
United States Patent Application 20160158209
Kind Code A1
Godek; Dennis Michael ; et al. June 9, 2016
Compounds for Treatment of Alzheimer's Disease
Abstract
The invention is directed to the use of a compound of formula I, as defined herein, to a pharmaceutically acceptable salt thereof; to a pharmaceutical composition containing a compound of formula I, and to a combination of a compound of formula I with a pharmacologically effective cholinesterase inhibitor to treat a mammal, including a human, for a disorder or condition selected from the list including Alzheimer's disease, Huntington's disease, Parkinson's disease, non-Alzheimer's dementias and ALS.
Inventors: Godek; Dennis Michael; (Glastonbury, CT) ; Howard; Harry Ralph; (Bristol, CT)
Applicant:
Name
Godek; Dennis Michael
Howard; Harry Ralph
City
Glastonbury
State
Bristol
Country
Type
CT
CT
US
US
Assignee: MediSynergics, LLC
Newington
CT
Family ID: 56093272
Appl. No.: 14/854928
Filed: September 15, 2015
Related U.S. Patent Documents
Application Number
Filing Date
Patent Number
14523278 Oct 24, 2014 9169237
14854928
61899181 Nov 2, 2013
Yes... 5-wk Part A + 26-wk Part B = 31 wks
That's the million-dollar question! I'll let you know when I see it. :)
Yeah, I'm selling at the top this time. ;)
We have two more days...but they could also delay the PR. I don't think there's a "deadline" for such a PR.
Might it be TauRx? If so, I'm not too concerned.
The Tau protein has already been implicated in the onset of Alzheimer’s, with many biotechs on the hunt for a preventative therapy. Now, a University of Aberdeen (UK) associated biotech, TauRX, have drawn €120M for their phase III therapy. With a major researcher from Cambridge (UK) leading the trials and a dramatic set of phase II results, this latest investment could push the Biotech industry into a whole new era for Alzheimer‘s research.
TauRx-Logo-01TauRX is a spin-off biotech from the University of Aberdeen in Scotland (UK) where its clinical trials are being conducted, although its official headquarters are based in Singapore (for tax reasons, perhaps?!). Their Alzheimer’s pipeline has led to the latest generation of their Tau-aggregation inhibitors (TAIs) attracting a massive €120M funding round for its phase III trials.
Is it "he" or "they"? I think it's the latter. Corey is just a mouthpiece.
The institutions will likely be holding their shares as it makes up a portion of their Russell 3000 equivalent ETF and/or Mutual Fund Index.
Corey obviously doesn't realize that Phase-1 is not needed for the other CNS trials, since it's already been proven safe in Phase-1 of the Alz trial.
Overall, it seems that "they" are starting to change their tune about AVXL. The tone is much softer now that the cartel has likely established its long position. :)
Might it be possible that this is the beginning of the end of gross price manipulation? If the hedge fund(s) that have played havoc in the past were involved in selling the volume of shares to the institutions last Friday, then perhaps they won't be screwing them going forward. Any thoughts to this?
Cbd, in FierceBiotech today...
British cannabinoid company GW Pharmaceuticals ($GWPH) was up about 15% in early trading on news that its lead candidate, Epidiolex (cannabidiol or CBD), had positive Phase III data in the treatment of a rare and severe kind of epilepsy. In March, it also released positive Phase III data for the candidate to treat Dravet syndrome; the candidate has Orphan Drug Designation from the FDA in both indications.
The company said it expects to submit an NDA for Epidiolex to the FDA during the first half of next year. The latest data were in Lennox-Gastaut syndrome (LGS) patients, who are difficult to treat, with most not getting an adequate response from existing treatments.
“Epidiolex represents an exciting potential new class of anti-seizure drug, which may lead to meaningful seizure management and otherwise treatment resistant patients in the setting of a well-tolerated safety profile,” said GW Pharma CEO Justin Gover on a June 27 call about the data.
With the latest data alongside the data from March, “We believe that these two events together have remarkably changed the profile and future prospects with GW,” he added.
LGS is a rare and severe form of childhood-onset epilepsy. The 171-patient randomized, double-blind, placebo-controlled Phase III trial found that Epidiolex had a statistically significant median reduction in monthly drop seizures of 44%, as compared with 22% for placebo, during the 14-week treatment period. That was the primary endpoint of the trial. Patients in the trial had already been treated with an average of 9 antiepileptic drugs.
Specifically, drop seizures are atonic, tonic and tonic-clonic seizures involving the entire body, trunk or head that led or could have led to a fall, injury, slumping in a chair or hitting the patient’s head on a surface.
Epidiolex patients reported an 86% rate of adverse events, as compared with 69% for placebo patients. The most common, occurring in more than 10% of patients, were diarrhea, somnolence, decreased appetite, pyrexia and vomiting.
The company expects to report on a second, 225-patient Phase III trial in this indication. This is a dose-ranging trial with three treatment arms with top-line data expected around the end of the third quarter.
It has previously said that it may submit to the FDA for Epidiolex together for both Lennox-Gastaut and Dravet syndromes. This spring, it also started a Phase III trial for the candidate in a third indication: tuberous sclerosis complex.
GW has an upcoming pre-NDA meeting with the FDA on Epidiolex in Dravet syndrome, and it will request a separate meeting for the candidate in Lennox-Gastaut syndrome. But it does believe the indications are related and may be reviewed together.
“With this positive LGS data now in hand, we anticipate requesting a pre-NDA meeting for Epidiolex in Lennox-Gastaut syndrome with the FDA to discuss these results,” said CMO Dr. Stephen Wright on the call about the data. “We're also expecting to have our pre-NDA meeting regarding Dravet syndrome very soon. It's pretty conventional that you hold a separate pre-NDA meeting for each indication in which you are developing your drug. … So the chances are that they will--they may put a different review onto one indication, then on to another,” he added.
“But as we signaled, we clearly think there's a relationship between the two syndromes that we've been looking at, many of the seizure types of over that, many of the patients are in the instant chart and adolescent age group. We would certainly hope and aspire to be discussing the Lennox-Gastaut results with FDA at the pre-NDA meeting for Dravet,” concluded Wright.
The company already markets Sativex, a cannabinoid to treat spasticity due to multiple sclerosis, outside the U.S.; it is also in development in cancer pain.
GW Pharma got a big bump up on the data in Dravet syndrome in March; it’s gained almost 50% so far this year to bring its market cap to more than $1.5 billion.
Seems to be a rating based on "fundamentals" (i.e. revenue) rather than the science and potential.
I'm afraid you're correct. Seems odd that they would file a patent for melanoma when they are pursuing an Alz treatment.
What's curious, is that if you read the original patent application it doesn't mention melanoma (that I could find). So it would seem the application was modified along the way.
Hopefully, Anavex already has an application submitted, not only for Alz, but for multiple indications. I'm anxious to hear what the company has to say.
Perhaps it's a robo produced article, but I don't think they would include any companies that they had short positions against.
I sent an email to IR and Anavex last week asking for clarity on the scope of the below patent. It mentions melanoma in the claims, but not within the body of the patent. The body of the patent addresses more of the MoA regarding Sigma receptors and cell stress, etc. So was hoping it covered a broader scope.
IR did respond that they had forwarded my email to the company for a response.
United States Patent 9,180,106
Vamvakides November 10, 2015
________________________________________
Sigma receptors ligands with anti-apoptotic and/or pro-apoptotic properties, over cellular mechanisms, exhibiting prototypical cytoprotective and also anti-cancer activity
Abstract
The present invention involves new and original sigma receptors ligands: (Mono- or dialkylaminoalkyl)-.gamma.-butyrolactones, their analogues aminotetrahydroturanes, the (1-adamantyl)benzene alkylamines, the N,N Dialkyl .alpha.-[(adamantyl-1)benzyloxy-2]alkylamines and the 3-cyclopentyl adamantyl-amines or alkylamines or -alkyl phenylamines, their enantiomers or diastereoisomers, their pharmaceutically acceptable salts and Quinacrine Me-thylene blue, Asteinizole and their relative analogues with pro-apoptotic and/or anti-apoptotic properties over cellular biochemical mechanisms, with prototypical anti-cancer, antimetastatic and antiviral activities associated with antagonism of the neuropatic pain and, at very low doses, with cytoprotective and cytoregenerative activity against the cytodegenerative diseases.
________________________________________
Inventors: Vamvakides; Alexandre (Ymittos Attiki, GR)
Applicant: Name City State Country Type
Anavex Life Sciences Corp.
New York
NY
US
Assignee: Anavex Life Sciences Corp. (New York, NY)
Family ID: 42083964
Appl. No.: 14/205,637
Filed: March 12, 2014
The invention claimed is:
1. A method of treating melanoma in a subject comprising administering in a subject in need thereof a therapeutic amount of a first compound shown here ##STR00001## and a therapeutic amount of a second compound selected from the group consisting of quinacrine, methylene blue, or astemizole.
2. The method of claim 1 wherein the second compound is quinicrine.
3. The method of claim 1 wherein the second compound is methylene blue.
4. The method of claim 1 wherein the second compound is astemazole.
5. A method of treating melanoma in a subject comprising administering in a subject in need thereof a therapeutic amount of a first compound shown here ##STR00002## and a therapeutic amount of a second compound selected from the group consisting of quinacrine, methylene blue, or astemizole.
6. The method of claim 5 wherein the second compound is quinicrine.
7. The method of claim 5 wherein the second compound is methylene blue.
8. The method of claim 5 wherein the second compound is astemazole.
9. A method of treating melanoma in a subject comprising administering in a subject in need thereof a therapeutic amount of a first compound shown here ##STR00003## and a therapeutic amount of a second compound selected from the group consisting of quinacrine, methylene blue, or astemizole.
10. The method of claim 9 wherein the second compound is quinicrine.
11. The method of claim 9 wherein the second compound is methylene blue.
12. The method of claim 9 wherein the second compound is astemazole.
13. A method of treating melanoma in a subject comprising administering in a subject in need thereof a therapeutic amount of a first compound shown here ##STR00004## and a therapeutic amount of a second compound selected from the group consisting of quinacrine, methylene blue, or astemizole.
14. The method of claim 13 wherein the second compound is quinicrine.
15. The method of claim 13 wherein the second compound is methylene blue.
16. The method of claim 13 wherein the second compound is astemazole.
________________________________________
Description
________________________________________
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to sigma(a) receptors ligands with anti-apoptotic and/or pro-apoptotic properties for use in connection with exhibiting prototypical cytoprotective properties associated with cytoregenerative activity developed by antagonism of the endoplasmic reticulum stress (ER stress) via activation of the sigma receptors in the connecting membrane between ER and mitochondrion.
SUMMARY OF THE INVENTION
In view of the foregoing disadvantages inherent in the prior art, the present invention provides an improved sigma(a) receptor ligands and method for using, and overcomes the above-mentioned disadvantages and drawbacks of the prior art. As such, the general purpose of the present invention, which will be described subsequently in greater detail, is to provide a new and improved sigma(a) receptor ligands and method which has all the advantages of the prior art mentioned heretofore and many novel features that result in a sigma(a) receptor ligands which is not anticipated, rendered obvious, suggested, or even implied by the prior art, either alone or in any combination thereof.
To attain this, the present invention essentially comprises a method for using a compound including sigma(a)-receptor ligands and a sigma(a) ligands generics. The method includes the providing of a compound having a sigma(a)-receptor ligands and a sigma(a) ligands generics, wherein the sigma(a) ligands generics is selected from Quinacrine, analogues of Quinacrine, Methylene blue, analogues of Methylene blue, Astemizole, and analogues of Astemizole. Then method further includes using the composition for the preparation of pharmaceuticals.
The pharmaceuticals have anticancer, antimetastatic and antiviral activity associated with analgesic properties.
The sigma(a)-receptor ligands may also be selected from (mono- or dialkylaminoalkyl)-y-butyrolactones), aminotetrahydrofuranes, enantiomers or diastereoisomers of aminotetrahydrofuranes, (1-adamantyl)benzene alkylamines, enantiomers or diastereoisomers of (1-adamantyl)benzene alkylamines, N,N di-alkyl a[(adamantyl-1)benzyloxy-2]alkylamines, enantiomers or diastereoisomers of N,N dialkyl a-[(adamantyl-1)benzyloxy-2]alkylamines, 3-cyclopentyl adamantyl-amines or -alkylamines or -alkyl phenylamines, enantiomers or diastereoisomers of 3-cyclopentyl adamantyl-amines or -alkylamines or -alkyl phenylamines, and their pharmaceutically acceptable salts.
There has thus been outlined, rather broadly, the more important features of the invention in order that the detailed description thereof that follows may be better understood and in order that the present contribution to the art may be better appreciated.
The invention may also include the preparation of pharmaceuticals having analgesic activity against neuropathic pain, acting synergistically with clinically used anticancer drugs and antagonizing neuropathic pain induced by the anticancer drugs, pharmaceuticals with cytoprotective activity against pathogenesis of cytodegenerative diseases, pharmaceuticals with cytoprotective and cytoregenerative activity, and pharmaceuticals with protective activity against the pathogenesis of inflammatory and neuropathic pain. There are, of course, additional features of the invention that will be described hereinafter and which will form the subject matter of the claims attached.
Numerous objects, features and advantages of the present invention will be readily apparent to those of ordinary skill in the art upon a reading of the following detailed description of present, but nonetheless illustrative, embodiments of the present invention. In this respect, before explaining the current embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of descriptions and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent constructions insofar as they do not depart from the spirit and scope of the present invention.
It might very well signal that they are fully loaded with shares and want to pump this back up with retail's help.
I'm not knowledgeable about the pharmaceutical industry, but it would seem Anavex could keep control of its future by partnering with a generic drug type manufacturer that has distribution channels already in place. There would certainly be no need for Sales and Marketing if 2-73 proves as effective and safe as expected. It would seem that a drug mfr of this type would love to partner with Anavex if even only 20% of the revenue. Does this make sense to those more knowledgeable of the industry?
If so, it wasn't from retail... not in AH.
How can 2 trades of 245,712 shares happen without changing the price? Go figure...
17:19 $ 4.5442 245,712
17:18 $ 4.5491 245,712 - Cancelled Trade
17:16 $ 4.5445 47,975
17:14 $ 4.5491 47,975 - Cancelled Trade
17:11 $ 4.55 520
17:04 $ 4.5493 2,161
17:02 $ 4.73 1,200 HIGH
16:52 $ 4.5491 245,712
16:52 $ 4.5491 47,975
16:47 $ 4.55 921
16:46 $ 4.55 7,601
16:43 $ 4.55 1,600
16:42 $ 4.54 400
16:42 $ 4.55 200
16:41 $ 4.55 612
16:41 $ 4.55 69,246
16:41 $ 4.55 14,709
16:38 $ 4.55 69,246 - Cancelled Trade
16:37 $ 4.55 14,709 - Cancelled Trade
16:36 $ 4.5498 1,445
16:30 $ 4.5495 14,653
16:23 $ 4.5498 31,879
16:17 $ 4.5493 51,200
16:16 $ 4.549 21,978
16:15 $ 4.5491 68,464
16:14 $ 4.55 69,246
16:14 $ 4.55 14,709
16:08 $ 4.5387 230
16:08 $ 4.49 57 LOW
16:01 $ 4.55 4,730
16:01 $ 4.55 2,620
16:01 $ 4.55 11,710
16:01 $ 4.55 4,500
16:01 $ 4.55 12,077
16:01 $ 4.55 3,700
16:01 $ 4.5493 52,427
16:00 $ 4.54 400
Excellent point. The extended trial will be of most interest as a measure of continued safety and efficacy.
If BTD is not granted this year, then there will be two trials ongoing for 2-73 in which the FDA will get valuable data: Alz and Rett's
2-73 patent (#9,180,106) issued Nov. 10, 2015.
Can someone provide additional insights into the scope of this patent? In the claims section, it mentions melanoma; however, the body of the patent seems to make a broader claim, as excerpted below... Do patents have to be written explicitly for each indication (i.e. Alz) or just describe the MoA and list the applicable indications it claims to address?
Field of the Invention
The present invention relates to sigma(a) receptors ligands with anti-apoptotic and/or pro-apoptotic properties for use in connection with exhibiting prototypical cytoprotective properties associated with cytoregenerative activity developed by antagonism of the endoplasmic reticulum stress (ER stress) via activation of the sigma receptors in the connecting membrane between ER and mitochondrion.
...having analgesic activity against neuropathic pain, acting synergistically with clinically used anticancer drugs and antagonizing neuropathic pain induced by the anticancer drugs, pharmaceuticals with cytoprotective activity against pathogenesis of cytodegenerative diseases, pharmaceuticals with cytoprotective and cytoregenerative activity, and pharmaceuticals with protective activity against the pathogenesis of inflammatory and neuropathic pain.
...the invention is not limited in its application to the details of construction and to the arrangements of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments and of being practiced and carried out in various ways.
Thus, in contrast to the precedent patents of the inventor, the above invention displaced the area of the putative application of these molecules from the symptomatic to the therapeutic use because, specially for the cytoprotecting and cytoregeneratingi properties of the following claims the activity of the molecules concern the intracellular targets and pathways of pathogenesis and not the activity of superficial cell membrane receptors, as it is usually the case with the symptomatic drugs: neuroleptics, anti depressive drugs and cholinergics for, respectively, psychosis, depression and Alzheimer.
http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9180106.PN.&OS=PN/9180106&RS=PN/9180106
Not yet...but we should know by next week, with PR.
I don't believe it will truly "pop" until one of two things happen:
1. Great news on 12-wk PK/PD data with clarity on P3 funding
2. BTD and/or fast-track announcement
Any or all of these could happen yet this year. IMO.
4:50pm EDT.
I think it's going to take more than the 12-wk data to generate the kind of demand we need to take this thing substantially higher and stay there. I think we're going to need P3 funding clarity or BTD and/or fast-track.
And I also see where you're coming from...but to say you're "not playing against anyone but retail" is a fallacy, because in reality you're playing against the MMs and hedge funds. They are the ones who mostly control the pricing, not retail. So, in fact, you're trying to play their game and guess where they want to take the price next.
Certainly, there will come a time with AVXL when news becomes so great that it will momentarily halt the game, as demand goes through the roof, and we (little retail investors) will be able to realize a profit. That day is coming soon...
How can we be on a "level playing field" (as you say) if the stock market is crooked...especially with microcap stocks that are easily manipulated? Since the SEC is unable or refuses to do its job, we all have to deal with these crooked forces. Yes, we're all equally affected, but in no way is it "level". It's not like we're competing against mother nature; these forces that have control are created by greedy nefarious hedge funds and MMs, playing with our money for their benefit. It's certainly not a "level playing field" for them...they make money whenever they want, and usually at our expense. Yes, we all know how the game is played, and yet we continue to play it, because we think at some point it will be different.
It's only as far as their announcement for P3 funding or BTD and/or fast-track... any of which could come at anytime. I just don't think that the 12-wk data by itself will have a sustaining affect on PPS. IF double digits is hit with 12-wk data, it will likely be short lived, unless there is other news to go with it. IMO
Certainly has the potential of initial high impact, but good news is also expected. If it does cause a surge in PPS, it's likely not sustainable by itself, due to the expected subsequent short selling to bring the PPS back down. I just don't think there's enough awareness yet about the company and drugs to generate the kind of investor demand to counter the nefarious shorting cartel.
I certainly hope I am wrong.
Even though the 12-wk PK/PD data will likely be good, I suspect that it won't sustain a higher PPS, due to the ongoing attacks by the nefarious cartel. These short attacks will continue until there is a clear roadmap of P3 funding and the news disseminates broadly to bring in much more investor demand.
Of course, BTD and fast-track would be a huge binary event in itself and would certainly lead to broad awareness. It's becoming more of a possibility...
That we know, and is often times abused...is my point.
"creating liquidity" in itself is not a natural market force; it is "fabricated activity" and, when taken to extreme, creates a false sense of volume and does not represent a true market.