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Alzheimer's News Today
Neurotrope Concludes Patient Dosing, Monitoring in Clinical Trial of Bryostatin-1 for Alzheimer’s
March 7, 2017 by Daniela Semedo, PhD In News.
Neurotrope has finished dosing and monitoring patients in a Phase 2 clinical trial to evaluate Bryostatin-1, the company’s lead drug candidate for treatment of moderate to severe Alzheimer’s disease.
The randomized, double-blind, placebo-controlled, Phase 2 clinical trial (NCT02431468) is assessing the safety, tolerability and efficacy of bryostatin-1 in 148 people with Alzheimer’s. Patients underwent a 12-week treatment with Bryostatin-1, followed by a 30-day post-treatment evaluation.
The trial’s primary efficacy endpoint is the post-treatment change on the Severe Impairment Battery, a scale assessment widely used in Alzheimer’s drug trials. Secondary efficacy endpoints will include “Activities of Daily Living,” “Neuropsychiatric Inventory” and “Mini-Mental State Exam.”
This study follows a now completed Phase 1/2 clinical trial (NCT02221947) that evaluated the preliminary safety, efficacy, biological effects and properties of Bryostatin-1 in 15 patients with Alzheimer’s.
Neurotrope CEO Susanne Wilke said she was “very pleased” with the study, which took only 13 months from start to finish.
“A reversal of Alzheimer’s progression would represent a major step forward in the treatment of Alzheimer’s dementia patients after years of failed previous trials by other companies and institutions that predominantly targeted amyloid plaque or tau neurofibrillary tangles,” Wilke said in a press release. “Those trials, thus far, have not achieved a significantly reduced rate of decline or improved cognition in any group of patients diagnosed with Alzheimer’s dementia — mild, moderate or severe.”
Daniel Alkon, MD, president and chief scientific officer of the New York-based biopharmaceutical company, said that although the pathologic hallmarks of Alzheimer’s — extracellular plaques and intracellular tangles at autopsy — are essential in identifying people who in fact had the disease, plaques and tangles are not closely related to functional decline.
“In contrast, the loss of synaptic networks has been found, with numerous autopsy studies, to correlate with the severity of cognitive dysfunction and disease progression,” he said. “We at Neurotrope believe that the regenerative effects of Bryostatin’s treatment on the synapses, as well as Bryostatin’s prevention of amyloid and plaque deposition, may not just reduce but potentially reverse the symptoms by addressing for the first time many of the major early causes of this devastating disease.”
Bryostatin-1 is a protein kinase C (PKC) modulator. Neurotrope said that in studies with Alzheimer’s animal models, it was shown to be effective for restorative synaptogenesis (generation of new synapses, or connections between neurons), prevention of neuronal death, and anti-amyloid, anti-tau metabolism (the two proteins connected to Alzheimer’s), offering the potential to improve cognition, memory and behavior in patients.
https://alzheimersnewstoday.com/2017/03/07/neurotrope-ends-patient-dosing-and-monitoring-in-clinical-trial-of-bryostatin-1-for-alzheimers/
I would agree with this tweet that was just posted on the $NTRP Twitter feed.
R? @Lucy3370
$ntrp Alzheimers TL ph2b data in April will prob b 1 of the biggest bio binary events in 2017.currently 19.60.upside $70-90-downside $2-5
"The Phase IIb study protocol is EXCELLENT that is a classic gold standard drug trial."
For those of us who are not in the research field could you elaborate on your statement?
GentleGiant, here is a link to NTRP's Ph2b study:
https://clinicaltrials.gov/ct2/show/record/NCT02431468?term=Neurotrope&rank=1
I am not sure what you are referring to "The reason they only have 6+3 patients" in your post.
Best you check with Investor Relations. I still expect one week or so.
You are correct Index Funds, at least, should be buying and with the tiny float it could have a dramatic effect on the share price.
No, they have applied to NASDAQ. Should be up listed in a week or so.
It is possible that we will see increased buying from Funds when that occurs.
Rubyred, thanks for the link.
Rubyred, please be so kind as to provide a link to your figures.
Thank you, SF Wolf
Selett, as you say “6+M outstanding 12.5M fully diluted” but the float is miniscule, somewhere in the neighborhood of 3.5 million shares.
With positive Ph2b results this stock will blast off like a rocket ship!
GentleGiant, thank you for your informative posts and the benefit of your obvious technical background in medical research.
Assuming that NTRP announces a positive outcome in their Ph2b study (and I am assuming they will based on animal studies, compassionate use cases, and the recent positive public statements by company officers) what, in your opinion, will be the most expeditious route for securing FDA approval for the use of Byrostating 1 in treating AD?
Some obvious questions for NTRP investors regarding Dr. Alkon’s upcoming March 22nd Keynote presentation at the Sachs Associates 2nd Annual Neuroscience BioPartnering & Investment Forum:
--Was Dr. Alkon invited as this year’s Keynote speaker due to recent developments in Neurotrope’s Bryostatin Alzheimer study? (He was also the keynote at last year’s conference.)
-- In his comments will Dr. Alkon review Neurotrope’s AD Ph2b study? If so, will his comments discuss anecdotal results or possibly a more detailed examination of the study outcomes? (I would think that in three weeks time NTRP and Dr. Alkon will have un-blinded study results and be deep into statistical analysis of the data).
--Will Dr. Alkon seek Big Pharma investment partners? “The event is targeted at buy and sell side analysts from investment banks and funds and partnering executives from pharma.”
MARCH 27TH could be a significant day for Neurotrope:
Dr. Daniel Alkon, President and Chief Science Officer of Neurotrope Bioscience, Inc. will be the Confirmed Keynote Speaker at the Sachs Associates 2nd Annual Neuroscience BioPartnering & Investment Forum. Dr. Alkon will speak at 1:30 PM at this one day conference.
The “ 2nd Annual Neuroscience BioPartnering & Investment Forum (is) to take place on the 27th of March at the New York Academy of Sciences. Event will focus on key areas of neurodegenerative diseases and pain management with a mix of specialist panels and company presentations. The event is targeted at buy and sell side analysts from investment banks and funds and partnering executives from pharma. We anticipate over 200 delegates and more than 20 presentations by listed and private biotechnology companies seeking licensing & investment opportunities.”
“Therapeutic Panels will include:
Advances in Alzheimer’s Disease
Parkinson’s Disease & Other Movement Disorders
Rare & Orphan Diseases
Neuropsychiatry & Pain Management”
“Confirmed Keynote include:
Dr. Daniel Alkon, President and CSO, Neurotrope Bioscience, Inc.”
http://www.sachsforum.com/2nbpi-about.html
Confirmed Attending Companies Include: (Neurotrope, Astra Zeneca, Johnson & Johnson, Lilly, Merck, Roche, etc.) http://www.sachsforum.com/2nbpi-attendees.html
Confirmed Financial, Advisory and Investors Include: (Aegis Capital, Lexington Capital, Michael J. Fox Foundation, Piper Jaffray, The Alzheimer’s Drug Discovery Foundation, etc.) http://www.sachsforum.com/2nbpi-investors.html
This was just posted on Twitter $NTRP:
Staying Bullish on Neurotrope Inc (OTCMKTS:NTRP) Shares
written by Edward Tarpin March 6, 2017
Neurotrope Inc (OTCMKTS:NTRP) shares were down 0.76% on Friday but company developments suggest that a longer-term uptrend could happen soon.
Neurotrope Inc (OTCMKTS:NTRP) shares were down 0.76% on Friday to $19.55 but up 1.02% to $19.75 in after-hours trading. Share prices have been trading in a 52-week range of $5.76 to $21.76. The company has a market cap of $131.18 million at 6.78 million shares outstanding.
Formerly BlueFlash Communications Inc, Neurotrope Inc is a biopharmaceutical company with product candidates in pre-clinical and clinical development. It is focused on developing a product platform based upon a drug candidate called bryostatin for the treatment of Alzheimer’s disease (AD), which is in the clinical testing stage. Bryostatin, which is a protein kinase C (PKC) Alpha and e activator, is also developed for other neurodegenerative or cognitive diseases and dysfunctions, which are in pre-clinical testing.
Its second generation PKC activators, such as the Bryologs are meant for the treatment of central nervous system disorders, lysosomal storage diseases, stroke, cardio protection and traumatic brain injury. It develops Bryostatin-1 for the treatment of Alzheimer’s disease along with the rare (Orphan) diseases, such as Fragile X Syndrome and Niemann-Pick Type C. It has completed Phase IIa clinical trials of Bryostatin-1 for the treatment of patients with AD.
In a press release, Neurotrope Inc announced the conclusion of dosing and patient monitoring in its Phase 2 double blind, placebo controlled clinical trial of bryostatin-1 in the treatment of moderate to severe Alzheimer’s dementia. In this clinical trial, patients underwent a 12 week treatment with bryostatin-1, followed by a 30-day post-treatment evaluation. The study is designed to assess the therapeutic efficacy of bryostatin-1, a PKC epsilon activator.
We are very pleased with the execution of the study. It took only about 13 months from initiation of randomization of the study to completion the last patient visit,” Dr. Susanne Wilke, Chief Executive Officer of Neurotrope Inc stated. “A reversal of Alzheimer’s progression would represent a major step forward in the treatment of Alzheimer’s dementia patients after years of failed previous trials by other companies and institutions that predominantly targeted amyloid plaque or tau neurofibrillary tangles. Those trials, thus far, have not achieved a significantly reduced rate of decline or improved cognition in any group of patients diagnosed with Alzheimer’s dementia, mild, moderate, or severe.”
Earlier animal studies have demonstrated the efficiacy of bryostatin for restorative synaptogenesis, prevention of neuronal death, and anti-amyloid, anti-tau metabolism via the activation of PKC epsilon.
The multi-modal efficacy of bryostatin-1 was extensively studied in both animal models and Expanded Access patients with advanced Alzheimer’s dementia. We believe that these studies demonstrated bryostatin’s potential to actually improve cognitive functions, not simply slow the rate of cognitive decline,” stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope Inc.
The company studied effects during the slow progression of AD pathogenesis in the AD transgenic mice designated Tg2576, which contain the single Swedish mutation, as well as during the more aggressive AD pathogenesis of the 5XFAD mouse strain. According to the results in the 5XFAD mouse strain, both bryostatin-1 and DCP-LA completely reversed the marked deficits of spatial maze learning and memory at 5 months postpartum when amyloid plaques were already abundantly distributed throughout the hippocampus. Also, DCP-LA treatment largely prevented both the deposition of the amyloid plaques and the loss of synaptic connections in the 5XFAD mice.
http://smallcapexclusive.com/staying-bullish-neurotrope-inc-otcmktsntrp-shares/
F1ash, this article you referenced is a very good overview of Dr. Alkon and Neurotrope. I hope every one on the board took the time to read it.
https://awesomecapital.wordpress.com/2017/02/18/neurotrope-alzheimers-trial-may-propel-share-price/
Fact Sheet: Breakthrough Therapies
(With successful test results I would expect that Neurotrope will apply for this program or a new Trump administration expedited approval process for Byrostatin 1):
On July 9, 2012 the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed. FDASIA Section 902 provides for a new designation - Breakthrough Therapy Designation. A breakthrough therapy is a drug:
• intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition and
• preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development
If a drug is designated as breakthrough therapy, FDA will expedite the development and review of such drug. All requests for breakthrough therapy designation will be reviewed within 60 days of receipt, and FDA will either grant or deny the request.
https://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm
runncoach, Bryostatin-1 has undergone testing in over 1,500 people, establishing a large safety database.
When you search clinicaltrials.gov you find “41 studies found for: Bryostatin”
I would assume every one of the 41 studies had some kind of safety component.
When you refine the search you find “14 studies found for: Bryostatin safety trials”
https://clinicaltrials.gov/ct2/results?term=Bryostatin+&Search=Search
Another quote from today's Press Release:
"We, at Neurotrope, believe that the regenerative effects of bryostatin's treatment on the synapses, as well as bryostatin's prevention of amyloid and plaque deposition, may not just reduce, but potentially reverse the symptoms, by addressing for the first time many of the major early causes of this devastating disease."
Neurotrope Bioscience Concludes Patient Dosing and Monitoring in its 148 Patient Phase 2 Clinical Trial of Moderate to Severe Alzheimer's Dementia
Top-line efficacy data is expected to be announced in April 2017
News provided by
Neurotrope, Inc.
Feb 28, 2017, 08:30 ET
"We are very pleased with the execution of the study. It took only about 13 months from initiation of randomization of the study to completion the last patient visit," Dr. Susanne Wilke, Chief Executive Officer of Neurotrope stated.
"The multi-modal efficacy of bryostatin-1 was extensively studied in both animal models and Expanded Access patients with advanced Alzheimer's dementia. We believe that these studies demonstrated bryostatin's potential to actually improve cognitive functions, not simply slow the rate of cognitive decline," stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "
http://www.prnewswire.com/news-releases/neurotrope-bioscience-concludes-patient-dosing-and-monitoring-in-its-148-patient-phase-2-clinical-trial-of-moderate-to-severe-alzheimers-dementia-300414678.html
“We certainly welcome a pharma partnership” Dr. Alkon (President and Chief Scientific Officer) said in a recent article (see below).
Scientists at NTRP are now conducting an analysis of their AD study’s statistics that will show whether Bryostatin’s end points were met in the 147 participants.
In my judgement, the fact that the President and Chief Scientific Officer at Neurotrope and others in the company are discussing the need for a Big Pharma partner is another “tell” that Top Line data due out this April will reflect positive test results from the Ph2b study.
"We're very hopeful that the drug will give us good data in April, and that cash reserve will allow us to negotiate with pharma partners from a position of strength," said Benison (Director of Communications).
"Our hope is," Alkon said regarding the Alzheimer's indication, "if we get good data, reverse and regenerative data, the FDA will say 'Look, this is something that we can't sit on. Let's accelerate this.'" With fast-track status, Neurotrope would need fewer patients to get Phase 3 qualifications "In which case, we will do a Phase 3 follow-up. We might do that with our own investor groups, we also potentially might do that in conjunction with a pharma partner. We certainly welcome a pharma partnership. There are many other indications that we think could be significantly benefited by this approach."
https://www.benzinga.com/general/biotech/17/01/8962220/taking-a-clinical-road-less-traveled-neurotrope-hopes-to-succeed-in-al
“Neurotrope holds around 70 patents on its bryostatin and even more importantly, the rights to use PKC epsilon for treatment of AD. Alkon put it this way, "Suppose somebody else, let's say Lilly, came up with a new PKC epsilon activator, and let's say that it had good efficacy. The drug they came up with would be theirs, but to use it to treat Alzheimer's they'd have to work with us." And of the prospect of teaming up with pharma partners? "We'd be happy to work with them."
https://www.benzinga.com/general/biotech/17/02/9061803/after-merck-stops-study-what-remains-of-the-alzheimers-drug-pipeline
blu, I think you should qualify your statement: “The problem with Neurotrope is that it doesn't address the cause of Alzheimer’s, which is accumulated oxidative stress”
First, it is your opinion is it not? And where is the research to prove your hypothesis?
Also, how does your idea account for families that have a clear genetic component for early onset Alzheimer’s?
F1ash, here is the press release.
http://www.neurotropebioscience.com/Welcome_to_Neurotrope_BioScience/PressReleases-jan-26-2017.html
Insightful Tweet:
R?@Lucy3370 16m
16 minutes ago
More
$ntrp seems 2b a pattern many days .sells off on no vol. MM's steal panicky retail shares & it goes back up
https://twitter.com/search?f=tweets&vertical=default&q=%24NTRP&src=typd
Neurotrope hopes to succeed with new tack in Alzheimer’s therapy
January 31, 2017
Some excerpts:
“For its Phase 2 trial of Bryostatin the company seeks to measure improvement in the Severe Impairment Battery — a neuropshycological test that measures dementia — as its primary endpoint. The SIB was chosen as the test best accepted by the industry to measure severe disease. Bryostatin, then, looks to not only reduce plaque and tau tangles, but regenerate synapses. “That’s what we hope will reverse the disease in Alzheimer’s patients,” Benison said. “Not only are we stopping the plaque and the tau, but we’re also activating these growth factors in the brain to increase the synapses.”
“When the company sought to obtain $8 million in financing it succeeded in raising triple that amount, with a total of $24.5 million raised by the final closing of its private placement, giving an indication of the type of interest Neurotrope has begun to generate.
“We’re very hopeful that the drug will give us good data in April, and that cash reserve will allow us to negotiate with pharma partners from a position of strength,”
“Our hope is,” Alkon said regarding the Alzheimer’s indication, “if we get good data, reverse and regenerative data, the FDA will say ‘Look, this is something that we can’t sit on. Let’s accelerate this.'” With fast-track status, Neurotrope would need fewer patients to get Phase 3 qualifications. “In which case, we will do a Phase 3 follow-up. We might do that with our own investor groups, we also potentially might do that in conjunction with a pharma partner. We certainly welcome a pharma partnership. There are many other indications that we think could be significantly benefited by this approach.”
https://awesomecapital.wordpress.com/2017/01/31/neurotrope-hopes-to-succeed-with-new-tack-in-alzheimers-therapy/
New Seeking Alpha article:
Torchlight Energy: The Hazel Project Is Worth $150 Million
http://seekingalpha.com/article/4048063-torchlight-energy-hazel-project-worth-150-million
Yes, in that case, I would agree with you. I did mischaracterize the odds makers odds in the hypothetical case. Thanks for clearing that up.
"an odds maker with little to no knowledge of NTRP would probably establish odds of 90-95% on the results being negative"
They would, but we are not in that position as you say.
We do have information concerning NTRP. Thus, for us, the odds change.
In any case, it is my subjective call.
Why Neurotrope is not a 50/50 binary bet.
Binary betting is a type of financial betting which displays the price of a bet as an odds index from 0 to 100 where the bet settles at 100 if an event happens and 0 if it does not. The greater the likelihood of an event happening the higher this price will be.
Binary betting - Wikipedia
https://en.wikipedia.org/wiki/Binary_betting
If there was little or no public information about NTRP’s soon to be released Top Line results of their Phase 2b study on the efficacy of Bryostatin in treating Alzheimer’s disease, an odds maker in that case, would assign a 50/50 chance.
But that is not the case with Neurotrope. We have had two public investor presentations by Neurotrope’s Dr. Alkon and Dr. Wilke in the last three weeks. That is where you will find the most up to date information (see notes and links below).
What odds would I assign that NTRP releases ground breaking AD research results? My odds: 80/20
----------------------------------------------------------------
Notes and links:
My Notes of Drs. Alkon and Wilke at the BIO CEO & Investor Conference 2/13/17
Dr. Wilke:
Minute 4:14: we are unique in that we are stating that we can regenerate synapses and synaptic networks. And by regenerating these synapses and synaptic networks we can actually reverse Alzheimer’s disease even in advanced patients.
Minute 4:29: we believe we have a uniquely regenerative mechanism that actually will show strong clinical benefit in our clinical trial which is different than just treating or preventing the formation of amyloid plaque.
Minute 5:18: we are pretty excited about our upcoming Phase 2 top line data in April 2017, as I said in moderate to severe AD patients, which we believe will be a pivotal inflection point for the company
Dr. Alkon:
Minute 17:54: I do want to say that Bryostatin is one of a platform of drugs that we have. It is our lead compound now because it has experience in the patient population and we know it’s well tolerated. But we have 40 or so other compounds some of which are even more potent and even more specific and have proprietary composition of matter protection which we can use for second and third generation of drugs.
Minute 23: (Bryostatin) is well positioned to virtually…take care of every major aspect of this disease. So it is multi modal, multi modal means that we can look at prevention, slowing down progression, and actual reversal of Alzheimer’s disease. Which is what is in our current Phase 2 trial.
Minute 25:45 (refer to Slide 40 – Bryostaten Compassionate Use Program: Severe Alzheimer’s Disease “No other reports have ever shown comparable benefits in such severely demented patients”) These are our compassionate use patients…we saw major reversal of disease that’s why we teed-up our Phase 2 trial in the way we did for severe (Alzheimer’s) patients to see reversal. To see not just a reduction in the rate of decline…but a flipping, a changing of the sign of what happens, for example, with the preferred metric of advanced Alzheimer’s disease, the Severe Impairment Battery.
https://www.veracast.com/webcasts/bio/ceoinvestor2017/18111483071.cfm
My notes of Susanne Wilke, PhD, Chief Executive Officer of Neurotrope, presentation at the Noble Financial Capital on 1/30/17:
Minute 8:25 "we are seeing remarkable results in reversal of Alzheimer's Disease"
Minute 10:41 "with this license we are able to synthesize Bryostatin in larger commercial quantities"
Minute 17:58 "we have compassionate use protocol results in Alzheimer patients that shows significant improvement in cognition and daily living..."
Minute 18:25: “we have Phase 2a completed which was a smaller Phase 2. We achieved our primary safety endpoint, we saw targeted engagement and we saw some limited cognitive enhancement in a short period of time.
Minute 26:42: “we are testing in late stage patients to make the point of a significant reversal (in AD). This treatment should be applicable to moderate to early stage to MCI (mild cognitive impairment) patients.
Top line results in April.
http://noble.mediasite.com/mediasite/Play/c54248f852db4353b8f007b16745782b1d
If, as I believe, that Neurotrope will be the first company in the history of AD research to report a treatment that actually works it is going to be the industry leader and dominate news on Alzheimer’s in the popular press. The term “media frenzy” comes to mind.
But more importantly, the Trump administration has indicated it wants less oversight and more fast track approval of promising drugs and it might turn out that with positive Phase2b results Bryostatin will be an early candidate for some kind of new FDA expedited approval process.
The potential societal and fiscal benefits will likely bring tremendous pressure on the FDA to act if Neurotrope is successful.
Alzheimer’s is a major drain on Medicare, Medicaid, and Social Security Disability benefit programs. An effective treatment will change the math on all of those programs saving families and governments all over the world untold billions.
F1ash, good find on the videos and the Life Sciences Interview!
This interview with Eden Rahim of Toronto based Next Edge Capital and a couple of others really gives us some insight into the reasoning of Micro BioTech investment funds and their interest in NTRP:
--Michael Bigger http://biggercapital.squarespace.com/biggercapital-investment/tag/neurotrope
--Paul Hardt http://www.onemednews.com/2017/01/28/paul_harte/ are a couple of other biotech portfolio managers which we have
Lucy, thanks for clarifying that.
A while ago I posted my stab at deducing the share structure of NTRP:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=128639889
I would appreciate your opinion and insight.
What is obvious to everyone is the extremely limited float (and total number of shares).
One more point about the NTRP warrants. When you elect to exercise them you have to send a check along with the warrants for the face value of the warrant. Either $6.40 or $12.80/share, in this case, which goes to NTRP. That is another disincentive to exercise if your objective is to wait out events, i.e. NASDAQ up-listing, Ph2b trial results, possible Big Pharma partner, etc.
You can't sell Neurotrope warrants into the market. They are non trading warrants. The warrants first have to be sent to the Transfer Agent. The Agent verifies the warrants and then issues a stock certificate. Once you receive the certificate you send it to your broker and the shares are put into your account.
Each individual investor will decide when to exercise their warrants. Some will, others will delay for a variety of reasons.
I think most of todays trading volume is day traders taking short term profit and computer trading programs cutting in front of retail.
A lot of positive comments on Twitter today:
https://twitter.com/search?f=tweets&vertical=default&q=%24NTRP&src=typd
I left this quote out of my previous post about Ray Dirks blog article:
I can't wait to see the data that the company will be releasing in five months, April 2017, from their 148 patient Phase II placebo controlled trial. Multi modal efficacy of bryostatin targeting PKC epsilon, versus everyone else's drugs, that are just trying to hit one target. It isn't even a fair fight. Neurotrope's bryostatin, if approved, is a blockbuster for one of the largest unmet medical needs in the world today.
This article is from Ray Dirk’s Blog 2&1/2 months ago. Amazingly, very little interest judging from the zero comments:
60 Minutes, Eli Lilly, Biogen, And Neurotrope, What A Story!
Nov. 30, 2016 2:51 PM ET
Some excertps:
“Dr. Alkon, currently President and Chief Scientific Officer of Neurotrope, (NTRP) was allowed under an FDA compassionate use program to treat the young lady. She was treated with a drug called bryostatin, which is not a statin, it activates PKC epsilon…
The activation of PKC epsilon activates the main amyloid degrading enzymes, ECE, neprilysin, and IDE while activating Alpha Secretase. Alpha Secretase has been a target for treating Alzheimer's. The problem has been finding a safe one. Eli Lilly's(LLY) and Biogen's (BIIB) drugs are monoclonal antibodies that inhibit amyloid beta. But Lilly's drug, solanezumab, just failed a major Phase III trial, showing it was no better at slowing down cognitive decline than placebo. Merck (MRK) has a BACE inhibitor that also inhibits amyloid beta. Neurotrope's bryostatin, in addition to degrading amyloid, also normalizes GSK3 beta. That mechanism prevents the hyperphosphorylation of tau. So you don't have to be a tauist or a baptist, bryostatin hits both targets.
Incredibly, bryostatin also activates growth factors in the brain, such as BDNF, NGF and IGF-1. This mechanism causes synaptogenesis. That allows the brain to restore damaged synapses and grow new synapses. The hope is that the damage caused by Alzheimer's disease may actually be reversed through this mechanism.
Dr. Alkon didn't start out by trying to find a drug to fight Alzheimer's. He was leading a department at the NIH trying to find out how to increase memory and he came upon PKC epsilon. PKC epsilon was the conductor in the center of the orchestra, arranging the different mechanisms to create the masterpiece of memory.”
http://seekingalpha.com/instablog/1240561-ray-dirks/4937731-60-minutes-eli-lilly-biogen-neurotrope-story
I believe NTRP telegraphed their expectations for their upcoming AD P2b results at the recent BIO CEO and Noble Conferences. In the end there was no equivocation, no doubts, that they expect a degree of success in their Ph2b trial. I think any reasonable person listening to both recordings would come to the same conclusion.
Looking over Nuerotope’s Power Point presentation from October 2016 I noticed on Page 16 that it states “First patients dosed January 2016”.
http://www.neurotropebioscience.com/Welcome_to_Neurotrope_BioScience/Neurotrope_BioScience_files/Neurotrope%20%20100516.pdf
What that tells us is that an unknown number of advanced AD patients have already completed their Bryostatin or placebo treatments. No doubt the researchers at NTRP have seen some of the raw data, even if it was still blinded, prior to their recent public presentations.
MY PERSONAL CONCLUSION is that Neurotrope very likely has an up-and-coming AD treatment. How efficacious that treatment is we will have to wait and see.
The most up to date source of information concerning Neurotrope’s Ph2b trial is in these two very recent investor presentations. Anybody invested in NTRP or considering investing would be well served to pay careful attention:
--BIO CEO Investor Presentation on 02/13/17: https://www.veracast.com/webcasts/bio/ceoinvestor2017/18111483071.cfm
Noble Financial Capital Presentating on 1/30/17:
http://noble.mediasite.com/mediasite/Play/c54248f852db4353b8f007b16745782b1d
Paul Harte – Portfolio Manager at Mt. Lucas Management (discussing his Investment in Neurotrope):
(Mount Lucas provides innovative investments to institutional and high-net-worth investors.)
BJ: I know that Alzheimer’s Disease is an area in which you’re quite keen on. Why Alzheimer’s?
PH: Alzheimer’s is the one disease left in the world that doesn’t have a cure. It’s a huge opportunity, a huge population comes down with Alzheimer’s. Every person is affected in one way in another with a friend family member with Alzheimer’s.
Big pharma has plowed billions of dollars into this area with no real success.
BJ: What did you like about the Neurotrope deal?
PH: Well it was interesting, it was a tiny $60 million market cap company that has a novel approach that’s actually at the end of a Phase II trial with results being reported in April. So it’s not pre-trial, it’s not being done on mice, it’s on humans in Phase II that had previously in Phase I, proven the safety of their approach, which also prove to reverse AD in part of the patients that they administered this drug to.
BJ: What’s your guess if they get positive results on this latest trial?
PH: The issue with Neurotrope, Promise Neurosciences and most of the companies I own, is that there’s a lack of visibility or awareness of these companies. That’s part of the charm of investing early – you invest at a very low price and if they execute and get discovered – there’s an opportunity for multibagger type returns.
We’ve looked at other companies. There’s nothing similar but there’s some apple-to-oranges that if their Phase II results are excellent and they progress into Phase III, and into potentially partnering with big pharma, then it could potentially be a billion dollar company. So, that would be roughly 16 times the value today.
Again, its a “high risk high reward”-type situation. In microcap world, the risk is bankruptcy, and the reward is huge because big pharma has spent billions of dollars trying to reverse the effects of AD, so the idea of one of these microcaps turning into a billion dollars company is not far fetched.
For full interview: http://www.onemednews.com/2017/01/28/paul_harte/
Xena, if I was a legal guardian for an advanced AD patient and they improved to the point of competency I would surly tell them that their improvement was the result of an experimental drug administered under my authority.
Would that mean there was a placebo effect. No, they would have been helped by the treatment before they knew they had received it.
Simple logic...
This is an insightful comment from the discussion over at Seeking Alpha:
Lawdawg05
You need to keep in mind that the people participating in this trial have moderate-severe or severe Alzheimer's disease. Their guardians have made the decision for them to participate in this trial, and the patients most likely have no idea that they are even involved in a trial. My point is that there will be no placebo effect. The professionals administering this trial know this, so if there are signs of efficacy, the professionals have reason to believe the patients are receiving bryostatin. The families likely appreciate this too.
http://seekingalpha.com/article/4046795-neurotrope-bioscience-upcoming-alzheimers-trial-results-may-propel-share-price
doingmybest you asked: “would you not view this as a take it all or nothing type of approach? Tackling the upper end of patients suffering is so much of a stretch given the current level of research on this drug and on success to date by other companies with this disease state that is strikes me as quite extraordinary. Is it just a home run shot by a newcomer taking a low probability attempt at a huge product, or, is it more completely reflective of their high degree of confidence based on all their sound work, which they view as a high probability of success, though without human data just yet.”
I have stated on this board that I believe NTRP telegraphed their expectations for their upcoming P2b results at the recent BIO CEO and Noble Conferences. In the end there was no equivocation, no doubts, that they expect success in their Ph2b trial. I think any reasonable person listening to both recordings would come to the same conclusions.
You wrote in another post, “I can attest to the excitement level working in a BP company a decade ago when there was a whisper of promise from the lab or the clinic due to the AD space being so coveted today in pharma.”
Looking over Nuerotope’s Power Point presentation from October 2016 I noticed on Page 16 that it states “First patients dosed January 2016”.
What that tells us is that an unknown number of advanced AD patients have already completed their Bryostatin or placebo treatments. Have the researchers at NTRP not already seen some of the human data, the raw data, even if it was still blinded? Probably.
I think that your poetic “whisper of promise” has excited the folks over at Nuerotrope.
http://www.neurotropebioscience.com/Welcome_to_Neurotrope_BioScience/Neurotrope_BioScience_files/Neurotrope%20%20100516.pdf