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I own both companies, I don’t dispute the science of either. The truth will prevail and I hope the science helps patients. It’s going to take several companies to address this disease. Anavex has already eliminated 20% from the start.
Now with that being said, I still have issue with the gaps, lapse or sloppiness of posters of Anavex. Integrity matters.
I had some bids out there but no one was willing to bend down to my level. I’ve paid up to $27 a share last year so now I’m trying to buy a little lower.
I have full confidence in Dr. Alkon.
In Australia a GP can diagnose Alzheimer’s? Who knows what those folks have or had.
Give me a link where Hampel knows about the great results of Bryostatin.
Hampel might jump ship like Dr Perry did when he sees Bryostatin results.
Greater than 95%.
DISCERN™ TEST
DISCERN™ is the only extremely accurate test for identifying and distinguishing AD from other forms of dementia.
DISCERN™ requires only a tiny skin sample, taken like a regular blood draw at the doctor’s office.
The test is relatively inexpensive, and far less expensive and intrusive than any existing tests for diagnosing AD, which include invasive spinal punctures (CSF Biomarkers) and PET scans.
Each biomarker has been proven, in human clinical trials conducted at major universities to be extremely accurate, with a sensitivity and specificity greater than 95% in both detecting AD and differentiating AD from other dementias.
Dr Alkon knows what he is doing.
NeuroDiagnostics, LLC New Alzheimer's Assay Granted Breakthrough Device Designation by U.S. Food and Drug Administration
DISCERN™ is the most accurate, least invasive and most cost-effective test for identifying Alzheimer's Disease
Oct 15, 2018, 5:45pm EDT
ROCKVILLE, Md., Oct. 15, 2018 /PRNewswire/ -- NeuroDiagnostics, LLC, a privately held neurological diagnostics company, announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation to NeuroDiagnostics' DISCERNTM multiple biomarker test for Alzheimer's Disease. If approved, this test could be the first FDA-approved test utilizing multiple biomarkers for identifying Alzheimer's Disease and differentiating Alzheimer's Disease from other dementias.
The Breakthrough Device Program is reserved for breakthrough technologies "that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions." Under the Breakthrough Device Program, the FDA works with device sponsors to reduce the time and cost of the approval decision by assigning an FDA Review Team to the Breakthrough Device and providing interactive and timely communication with the sponsor throughout the review process.
The DISCERNTM Alzheimer's disease test is the result of more than a decade of research and clinical studies conducted by the Blanchette Rockefeller Neuroscience Institute, now the West Virginia University Rockefeller Neuroscience Institute, utilizing clinically obtained patient samples provided by multiple university hospital centers, including Johns Hopkins University and Marshall University (as originally reported by Khan T, Alkon D, 2010, PNAS, and Chirila F, Khan T, Alkon D. 2013, J. Alzheimer's disease).
The DISCERNTM test is comprised of three novel proprietary biomarkers, each of which independently identifies and differentiates Alzheimer's Disease. The test requires only a small skin sample taken at the healthcare provider's office, much like a routine blood draw.
NeuroDiagnostics' biomarkers focus on the molecular cascades that are critical in the formation of synaptic networks.
Dr. Daniel Alkon, the Principal Investigator in the clinical trials and co-inventor of DISCERNTM noted that "there has been a critical, unmet need for an accurate and simple test for Alzheimer's disease. Existing methods to identify Alzheimer's Disease have limited accuracy, are expensive, and often invasive; those tests that require lumbar spinal tap are frequently avoided by many patients. Until now, a significant number of patients with dementia go undiagnosed, or worse, misdiagnosed. Each of the NeuroDiagnostics biomarkers independently has been found to show high sensitivity and specificity - in both detecting and differentiating AD from other dementias – as confirmed by autopsy validation."
About Alzheimer's Disease
Alzheimer's disease is a degenerative brain disease and the most common cause of dementia. Dementia is a syndrome - a group of symptoms - that has a number of causes. The characteristic symptoms of dementia are difficulties with memory, language, problem-solving and other cognitive skills that affect a person's ability to perform everyday activities. These difficulties are eventually followed by impairment of abilities to carry out basic bodily functions such as walking and swallowing. Such symptoms occur because nerve cells (neurons) and the connections between neurons - called synapses - are destroyed in the brains of Alzheimer's patients. People in the final stages of the disease are bed-bound and require around-the-clock care. Alzheimer's disease is ultimately fatal.
An estimated 5.7 million Americans of all ages are living with Alzheimer's disease in 2018. By 2025, the number of people age 65 and older with Alzheimer's dementia is projected to reach 7.1 million — almost a 29 percent increase from the 5.5 million age 65 and older affected in 2018.
The costs of health care and long-term care for individuals with Alzheimer's or other dementias are substantial, and dementia is one of the costliest conditions to society. Total payments in 2018 (in 2018 dollars) for all individuals with Alzheimer's or other dementias are estimated at $277 billion. The Association noted the enormous cost savings, both financial and emotional, that can be achieved with an accurate diagnosis even in the absence of a therapeutic. See the SPECIAL REPORT starting on page 58 of The Alzheimer's Association in its 2018 Alzheimer's Disease Facts and Figures Report, a statistical resource for U.S. data related to Alzheimer's disease.
Because Alzheimer's disease is under-diagnosed and underreported, a large portion of Americans with Alzheimer's may not know they have it.
Alzheimer's disease is officially listed as the sixth-leading cause of death in the United States. It is the fifth leading cause of death for those age 65 and older. However, it may cause even more deaths than official sources recognize. Alzheimer's disease is also a leading cause of disability and poor health (morbidity). Before a person with Alzheimer's disease dies, he or she lives through years of morbidity as the disease progresses.
About NeuroDiagnostics, LLC
NeuroDiagnostics, LLC is a privately held company focused on the research, development, and commercialization of diagnostics for neurological disorders and conditions. NeuroDiagnostics' laboratory in Rockville, MD is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing.
For more information, please contact info@neurodiagnosticsllc.com.
Related Links
NeuroDiagnostics, LLC Website
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SOURCE NeuroDiagnostics
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https://www.bizjournals.com/prnewswire/press_releases/2018/10/15/NY39817
Note the Dr that developed this device. Same Dr at Neurotrope.
Connect the dots.
I’m invested in both companies and research both. Don’t like board of Anavex but never argue against the science. Actually invested in Anavex first with over 10k shares.
It’s not a statin. Dr has said it several times. Do DD.
What? Not sure if aspirin works on 100% of patients.
NTRP drug can be taken pre-alz per recent presentation and at any stage.
Family members don’t care if it’s an IV as long as patients get better. Arguing against IV is alarming. 94% improved.
I repeat both companies treating same indication and 94% of patients improved. Stats significant.
Anavex was dosed with IV as well.
They have pill form and it can be administered at any stage including pre-alz.
Competitor news Neurotrope Presents Updated Phase 2 Data of Bryostatin-1 in Moderate to Severe Alzheimer's Disease at the 11th Edition of CTA...
Source: PR Newswire (US)
NEW YORK, Oct. 24, 2018 /PRNewswire/ -- Neurotrope Inc. (NASDAQ: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease, today announced the presentation of updated data from the Phase 2, multidose, exploratory trial evaluating Bryostatin-1 as a treatment of cognitive deficits in moderate to severe Alzheimer's disease ("AD"). The data were presented in a poster, entitled "Evidence of Sustained Low Dose Bryostatin Efficacy for Treatment of Alzheimer's Disease: Consistency of Multiple Evaluation Analyses" at the 11th Edition of Clinical Trials on Alzheimer's Disease ("CTAD") being held in Barcelona, Spain from October 24th - 27th, 2018.
"We are encouraged by the findings of this exploratory trial as we believe they are suggestive of the primary mechanisms of action of bryostatin, synaptogenesis and anti-apoptosis, or the generation of new, mature synaptic connections and the prevention of neuronal death," stated Dr. Daniel Alkon, President and Chief Scientific Officer of Neurotrope. "These results show a potential reversal of disease progression occurring in patients with moderate to severe AD treated with Bryostatin-1. Notably, this improvement persisted even 30 days after completion of all drug administration."
This study was designed to assess the safety and efficacy of Bryostatin-1 as a treatment of cognitive deficits in patients with moderate to severe AD (n=147). Patients enrolled in the study were allowed to continue on background therapy, including cholinergic and/or antiglutamatergic treatment. The primary efficacy analysis was change in Severe Impairment Battery (SIB) scores. For patients in the 20 µg Bryostatin-1 dose group (n=49, with 38 completers), the dose group being explored in an ongoing confirmatory Phase 2 study, SIB scores were consistently greater than baseline, indicating improvement in cognitive function. The magnitude of improvement was greater in a pre-specified exploratory analysis of patients not on memantine therapy (n=16). Memantine is an antiglutamatergic treatment whose mechanism of action may interfere with that of bryostatin-1. Analyses of patients in this group showed evidence of sustained SIB improvement over baseline compared to placebo patients not on memantine (> 6.30 points, 8.4 points when compared to all placebo). Individual patient trends over time revealed that 15 out of 16 patients (94%) in the 20µg Bryostatin-1, non-memantine group showed improvement in SIB by the end of the trial. No increase in SIB measures over time for the placebo patients or for patients on baseline memantine therapy was found.
A model for repeated measures (MMRM) was used in the trend analysis to provide consistency with the analysis of the whole patient sample. Based on the statistical trend analysis, the 20 µg Bryostatin-1 in the absence of memantine group shows a significant positive SIB trend (e.g. SIB improving over time). The treatment-by-time interaction, indicating a difference in treatment effect by arm, was highly significant (p < 0.001). These data indicate that benefit for the patients in the memantine-free group increase with dosing over time, including throughout the 15 week protocol.
Neurotrope is evaluating the 20 µg dose of Bryostatin-1 in patients not on memantine in a confirmatory Phase 2 trial, initiated in July, 2018, and evaluating 100 moderate-to-severe AD patients. Data from this study are expected during the second half of 2019.
The poster presentation information and poster presentation link are listed below.
Title: Evidence of Sustained Low Dose Bryostatin Efficacy for Treatment of
Alzheimer's Disease: Consistency of Multiple Evaluation Analyses
Abstract #: LBP14
Presentation Theme: Clinical trials: Results
Date/Time: Wednesday, October 24th, 2018: 1:00 – 4:00 PM
Location: Palau de Catalunya Conference Center
About Neurotrope
Neurotrope is at the forefront of developing a new approach to combating AD and other neurodegenerative diseases. The Company's world-class science offers the potential to realize a paradigm shift to overcome one of today's most challenging clinical problems — finding a way to slow or even prevent the progression of AD.
In addition to the Company's Phase 2 trial of Bryostatin-1 in advanced AD, Neurotrope has also conducted preclinical studies of Bryostatin-1 as a potential treatment for rare diseases and brain injury, including Fragile X syndrome, multiple sclerosis, stroke, Niemann-Pick Type C disease, Rett syndrome, and traumatic brain injury. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X. Bryostatin-1 has already undergone testing in more than 1,500 people in cancer studies, thus creating a large safety data base that will further inform clinical trial designs.
Please visit www.neurotrope.com for further information.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. These forward-looking statements include statements regarding the Phase 2 study and further studies, and continued development of use of Bryostatin-1 for Alzheimer's dementia and other cognitive diseases. Such forward-looking statements are subject to risks and uncertainties and other influences, many of which the Company has no control over. There can be no assurance that the clinical program for Bryostatin-1 will be successful in demonstrating safety and/or efficacy that we will not encounter problems or delays in clinical development, or that Bryostatin-1 will ever receive regulatory approval or be successfully commercialized. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Additional factors that may influence or cause actual results to differ materially from expected or desired results may include, without limitation, the Company's inability to obtain adequate financing, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, the Company's patent portfolio, the Company's inability to expand the Company's business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of the Company's raw materials, existing or increased competition, stock volatility and illiquidity, and the Company's failure to implement the Company's business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the SEC, including the Company's Annual Report on Form 10-K for the year ended December 31, 2017, and on Form 10-Q for the quarter ended June 30, 2018. The Company does not undertake to update these forward-looking statements.
Contact information:
Investors and Media
Sam Martin and Ryan Baker
Argot Partners
212-600-1902
Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neurotrope-presents-updated-phase-2-data-of-bryostatin-1-in-moderate-to-severe-alzheimers-disease-at-the-11th-edition-of-ctad-300736940.html
SOURCE Neurotrope Inc.
Copyright 2018 PR Newswire
10 years for 50% enrollment. Options could have been more specific. Could have read- reach 50% enrollment in 2 years with options expiring in 10 years. But no, it’s not stated so the expiration does matter. They have 10 years to get 50% enrollment.
Expected completion ALZ several years from now. Options expire 10 years for 50% enrollment. Not exactly motivation.
A well designed trial? CM met with the FDA early 2017 and they have yet to sign on.
If the FDA does not sign on to ALZ is the trial will designed?
I repeat fire the board.
Results in 2 to the 3 years, more dilution to come. Period. Company has history of delays and dilution.
Around $3.40 premarket.
Shorts and Missling only ones making money. Short on PR appears the path to recoup funds. This hit over $3.30 I will have to look at history.
Agree and we know it’s safe so no concern there. How about secondary?
Wait to see what the primary outcome is for the this Rhett’s trial. If it’s weak, watch out.
Write a paper is laughable. No need to retort that one. This baby is going one way.
The SOC for ALZ does not require analysis for 3 or more years. SOC was approved after trial for 6 months. It does not take all of this time for a trial. Why have a long AZ trial when SOC didn’t require. Just need to be better than SOC to get approval.
Board should be replaced.
Drug has not proven anything. Company still needs to fire the board.
Approval for what? Better sleep less irritable?
375 shares were exchanged AH
The dump is occurring as it appears others can see through the BS. There’s a drug and a company.
The company is ran like a bunch of amateurs.
This has been a horrible hold for me over the years. That’s the bottomline.
Period. Now say what you want. Later.
Wrong and not all of them and many companies don’t include precision medicine in the text
You see the market reaction is negative. Horrible press release and news. Leadership of Anavex are a bunch of idiots.
Precision medicine trials and many are in US.
https://clinicaltrials.gov/ct2/results?cond=&term=Precision+medicine+&cntry=&state=&city=&dist=