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2024 Lucid Air Vs. Mercedes-Benz EQS Sedan: Which Luxury EV Is BEST?
Wonder which EV is the best?
CarBuzz answers that exact question in their latest comparison video. Not only does the reviewer from CarBuzz fall in love with the exterior and interior styling of the Lucid Air but recognizes how it stands out in driving performance. Watch the comparison of Lucid Air and Mercedes-Benz EQS for yourself.1
Today marked another step forward in our company’s journey.
This afternoon, fresh out of our state-of-the-art paint shop and resplendent in stunning Infinite Black, the first Lucid Gravity SUV pre-production bodyshell dropped down from the roof conveyor onto the main production line at our factory in Casa Grande, AZ, reaching a significant milestone on our path to full production.
This marks the beginning of the Lucid Gravity pre-production run on our assembly line. Each unit will help us perfect the process and will be used for final validation testing to ensure top-tier build quality in full-scale production. Stay tuned for more updates as we continue to prepare for the start of Lucid Gravity's production.
Not all EVs are born equal.
https://www.linkedin.com/feed/update/urn:li:activity:7221309854789816320/?utm_source=marketingcloud&utm_medium=email&utm_campaign=gravity-pre-prod_info_aud_en-us_hrs_gravity_20240723&utm_content=https%3a%2f%2fwww.linkedin.com%2ffeed%2fupdate%2furn%3ali%3aactivity%3a7221309854789816320%2f&utm_term=
Lucid Motors Quadruples Its Arizona Manufacturing Plant And CEO Peter Rawlinson Explains Why
yeah 200 be sweet!!!!
why we get halted this morning?
https://thefly.com/news.php?symbol=SNPX
New Peer Reviewed Article Demonstrates Extended Therapeutic Potential of Synaptogenix's Bryostatin for Alzheimer's Disease
Treatment with Bryostatin shown to increase blood vessel health, a key factor for prevention and disease reversal
National Institutes of Health (NIH)-sponsored Phase 2b clinical trial of Bryostatin-1 in Alzheimer's disease (AD) patients currently underway
NEW YORK, April 5, 2022 /PRNewswire/ -- Synaptogenix, Inc. (Nasdaq: SNPX) ("the Company"), a clinical-stage biopharmaceutical company developing regenerative therapeutics for neurodegenerative disorders, today announced the recent publication of a collaborative peer-reviewed article in Frontiers in Aging Neuroscience. The research, led by Dr. Jarin Hongpaisan of the Kimmel Medical College of Thomas Jefferson University, resulted from a long-standing collaboration with Dr. Daniel Alkon, President and Chief Science Officer of Synaptogenix.
Dr. Alkon commented, "This publication of Bryostatin's new efficacy in a well-respected journal is exciting. Through samples accessed via our collaboration with the NIH-sponsored Harvard brain bank, we were able to identify evidence that brain samples from Alzheimer's patients had deficiencies in vascular micro-vessels. We identified the same deficiency in AD mice and subsequently treated them with Bryostatin. The treatment not only stabilized the decline, but importantly led to an increase in new micro-vessels. This exciting new data showing a quantitative increase in blood vessels in mice offers encouragement for our Phase 2b clinical trial of Bryostatin-1 in AD patients, which is currently underway."
George Perry, Chairman of Synaptogenix's Scientific Advisory Board and Semmes Distinguished University Chair in Neurobiology at the University of Texas, recognized for his work on oxidative stress in AD, stated, "Restoration of vascular and oxidative balance now joins synaptic function as Bryostatin's benefits, offering the hope that Bryostatin will cure the key deficits of Alzheimer's disease and aging. These findings support Protein Kinase C epsilon (PKC e) as a master regulator of aging and Bryostatin as a candidate for prevention and disease reversal."
About Synaptogenix, Inc.
Synaptogenix is a clinical-stage biopharmaceutical company discovering restorative, novel therapeutics for patients with life-altering neurodegenerative diseases and developmental disorders. Synaptogenix is currently conducting a National Institutes of Health-supported Phase 2b clinical trial of its lead therapeutic candidate Bryostatin-1 in patients suffering from moderately to severe Alzheimer's disease. In addition to AD, preclinical studies have demonstrated Bryostatin-1's regenerative mechanisms of action for the rare disease Fragile X syndrome, and the U.S. Food and Drug Administration has granted the drug Orphan Drug Designation for this indication. Other potential indications include multiple sclerosis ("MS"), stroke, and traumatic brain injury. Bryostatin 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. www.synaptogen.com
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 continued development of use of Bryostatin-1 for Alzheimer's disease, Fragile X, 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 its 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 its business plans or strategies. These and other factors are identified and described in more detail in the Company's filings with the Securities and Exchange Commission. The Company does not undertake to update these forward-looking statements.
Investors and Media Contact:
800-811-5591
ir@synaptogen.com
Robert Weinstein
Chief Financial Officer
Synaptogenix, Inc.
rweinstein@synaptogen.com
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Nio lands higher price target from Citi with strong volume anticipated
https://seekingalpha.com/news/3711106-nio-lands-higher-price-target-from-citi-with-strong-volume-anticipated?mail_subject=nio-nio-lands-higher-price-target-from-citi-with-strong-volume-anticipated&utm_campaign=rta-stock-news&utm_content=link-3&utm_medium=email&utm_source=seeking_alpha
Neurotrope to Present at the Alzheimer's Association International Conference; Neurotrope President and Chief Scientific Officer, Dr. Daniel L. Alkon, to Receive Cure Coin Award; Design of Confirmatory Phase 2 Trial to be Presented
NEW YORK, July 11, 2019 /PRNewswire/ -- Neurotrope, Inc. (Nasdaq: NTRP), a clinical- stage biopharmaceutical company developing novel therapeutics for neurodegenerative diseases, including Alzheimer's disease ("AD") is announcing that Dr. Daniel L. Alkon, the Company's President and CSO, will be honored among the recipients of the Cure Coin Award, at the InvestAcure Cure Coin Awards Reception on July 15, 2019 during the Alzheimer's Association International Conference in Los Angeles.
"We are proud to honor Dr. Alkon for his work in the development of Bryostatin, a natural compound showing promise in restoring synaptic networks in the brain, preventing neuronal death, clearing Tau and Amyloid buildup, and reversing Alzheimer's memory loss even for patients with late-stage disease," said Max Tokarsky, Founder & CEO of InvestAcure, PBC.
The award reception will bring together key stakeholders in the battle against AD, Dementia and CTE to honor industry scientists working to develop groundbreaking discoveries into effective treatments. NFL 'super-agent' Leigh Steinberg and former Vice Chairman of the NASDAQ David Weild IV are scheduled to host and keynote the event. The event program will also feature a presentation by InvestAcure, PBC Founder and CEO, Max Tokarsky, on their plans to drive $1 billion in annual investment for AD R&D until a cure is found.
The reception will be held at 7:00 p.m. at The Association on 110 E 6th Street in Downtown Los Angeles. InvestAcure welcomes members of the press to request attendance at the event. The event is expected to be at capacity, so please register as soon as possible. For additional details and registration, please visit the event page.
Neurotrope's Chief Executive Officer, Dr. Charles S. Ryan, will present the design of its confirmatory Phase 2 double blind, placebo controlled clinical trial of bryostatin-1 in the treatment of moderate to severe Alzheimer's dementia. The study design will be presented as a poster and Dr. Ryan will deliver an oral presentation. "We are delighted that the work of Dr. Alkon will be recognized, and look forward to the opportunity to present details of our confirmatory trial that will inform the development of a pivotal trial protocol for Bryostatin-1 in moderate-to-severe AD patients," said Dr. Ryan.
The poster presentation information is below.
Title: Replication Trial to Confirm Reversal of Cognitive Decline with Bryostatin for Advanced Alzheimer's Patients in the Absence of Memantine
(Poster presentation Abstract #35676)
Developing Topics Session: P4-661
Poster Presentations, Wednesday, July 17, 2019, 9:30 AM - 4:15 PM Pacific time.
Oral Presentation by Dr. Charles Ryan scheduled for 1:00 PM Pacific time at the Los Angeles Convention Center, South Hall GH.
About InvestAcure, PBC
InvestAcure, PBC is a finance company building an investment platform to enable individuals who share a 'Common Need' to see progress in developing a cure for Alzheimer's to automatically round up purchases and invest the change in a portfolio of companies working on effective treatments. The company's 3-year plan is to reach 1.7+ million users, investing $1 billion per annum to develop scientific innovations from basic research into lifesaving therapeutics.
Please visit www.investacure.com for further information.
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 U.S. Food and Drug Administration 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 AD 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 Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2018, and on Form 10-Q for the quarter ended March 31, 2019. The Company does not undertake to update these forward-looking statements.
Contact information:
Public Relations
Susan Roberts
sr@roberts-communications.com
202-779-0929
Investors and Media
Tom Caden
Vice President
CORE IR
516-222-2560
tomc@coreir.com
www.coreir.com
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Neurotrope Announces Participation at the 20th Annual Rodman & Renshaw Global Investment Conference in New York City September 4-6, 2018
https://www.prnewswire.com/news-releases/neurotrope-announces-participation-at-the-20th-annual-rodman--renshaw-global-investment-conference-in-new-york-city-september-4-6-2018-300703044.html
As Alzheimer’s drug developers give up on today’s patients, where is the outrage?
By SHARON BEGLEY @sxbegle
AUGUST 15, 2018
Demonstrators block the street in front of the New York Stock Exchange in 1989 to protest the high cost of the first AIDS drug. There has been much less outrage over the lack of drugs to treat Alzheimer's.TIM CLARY/AP
W
hen virologists and drug developers were too slow in finding ways to save the lives of people with HIV/AIDS and refused to give patients access to experimental drugs 30 years ago, activists chained themselves to a balcony on the New York Stock Exchange, held demonstrations where scores were arrested, and effectively shut down the Food and Drug Administration for a day.
The lack of progress against Alzheimer’s disease has brought somewhat less outrage. Although the latest analysis of experimental Alzheimer’s drugs finds that literally zero are being tested in late-stage clinical trials to treat moderate to severe Alzheimer’s, no patient advocacy groups uttered a peep in protest.
“We need a Larry Kramer,” said Dr. Sam Gandy, a neurologist and Alzheimer’s expert at Mount Sinai Hospital in New York, referring to the AIDS activist. Instead, he said, patients and their families adopt the fatalistic attitude that dementia is an inevitable consequence of aging, and funders see spending $1 on curing a child as ethically more justified (since it buys more total years of life) than spending $1 on an 80 year old, who’s closer to the grave.
While ageism partly explains why Alzheimer’s patients are being written off, just as gay men were in the 1980s, it’s not the whole story. For more than 20 years drug makers and academic scientists pursued treatments to slow or reverse dementia by targeting amyloid plaques in the brain. Every last one failed. Now companies and investors are instead focused on trying to prevent Alzheimer’s in younger people — potentially a huge, and hugely lucrative, market — or trying to ameliorate agitation and other behavioral symptoms of the disease. Meanwhile, alternative strategies for treating the disease have been largely ignored and underfunded, with little outcry.
“I don’t think most people have really internalized this, or are ready to hear about it,” said chemist Derek Lowe, a longtime pharmaceutical scientist who blogs about drug discovery. “It’s painful, and no one is going to come out and say flatly that people with existing Alzheimer’s damage are probably never going to get any better, and that it would take a major advance just to stop them from getting any worse. It sounds defeatist.”
Not every company has given up on the 5.5 million people in the U.S. who already have Alzheimer’s, all of whose disease will become tragically, mind-robbingly, identity-destroyingly severe if it isn’t already — and if they don’t die first.
“These are the very patients we have to help,” said Dr. Daniel Alkon, president and chief science officer of Neurotrope, which is running a Phase 2 clinical trial of a compound called bryostatin in patients with moderate to severe Alzheimer’s. That makes it literally the only Phase 2 or Phase 3 study of whether a drug can alter the course of disease in patients with severe dementia. “I absolutely do not think it’s hopeless.”
Alkon’s optimism (not shared by most experts) reflects his preclinical research showing that bryostatin boosts two kinds of molecules: those that degrade amyloid and those that increase synapse formation. The first mechanism of action might prevent the formation of synapse-destroying amyloid plaques, while the second might preserve and create synapses, whose destruction underlies the cognitive losses in Alzheimer’s. In lab mice, bryostatin reversed brain damage and improved memory. Neurotrope’s small Phase 2 trial suggests it might do the same for patients with moderate-to-severe Alzheimer’s, but the results still have to be confirmed in a larger trial.
Neurotrope is a complete outlier, however, and even Alkon can understand both the scientific and business case for drug developers’ decision to target mild Alzheimer’s, or even pre-symptomatic but at-risk (i.e. healthy) people.
For more than a decade, drug developers have based their experimental compounds on the amyloid hypothesis, convinced that ridding the brain of sticky amyloid plaques, and preventing new amyloid deposits, was the key to fighting the disease. Trouble was, quite a few drugs did reduce the amyloid burden, “but that didn’t do anything for cognition,” Alkon said. “So the thinking became, plaques are too late, we have to get rid of what causes the plaques,” namely, soluble amyloid molecules called oligomers. By definition, people without amyloid plaques do not have Alzheimer’s disease.
“The scientific rationale was, by the time people get moderate dementia, their brain is pretty filled up with amyloid and they’ve lost neurons and synapses,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. “And what drug developers want is to get a drug to market,” not waste time and money on noble but quixotic causes.
That means that in addition to a scientific justification for targeting earlier disease (or pre-disease), there was a business one. “No one was making any progress in targeting patients with moderate to severe disease,” Alkon said. Eli Lilly alone spent at least $1 billion, analysts estimate, on what turned out to be a failed antibody against amyloid. Such astronomically expensive failure in even moderate Alzheimer’s, he said, “has been the rationale of the entire industry” for why it has basically given up on patients who are losing their memories and their minds and, eventually, their lives.
“The moderate-to-severe patients got completely left in the dust,” said Fillit. “It’s driven by companies’ need for a success.” Given the 200-plus failed clinical trials of experimental Alzheimer’s drugs, the smart money says that is more likely to come from a drug that prevents the development of full-on dementia in people with mild cognitive impairment or even just risk factors (including genetic ones).
“The moderate-to-severe patients got completely left in the dust. It’s driven by companies’ need for a success.”
DR. HOWARD FILLIT, ALZHEIMER’S DRUG DISCOVERY FOUNDATION
Not everyone agrees that millions of patients have been abandoned. Nearly three dozen drugs in mid- to late-stage development aim to reduce agitation, sleep disorders, and other behavioral changes that accompany Alzheimer’s. Such drugs, if they work, could make a significant difference in the daily life of patients and caregivers even if they don’t alter the course of the actual disease. Clinical trials for these behavioral symptoms “continue to make up a significant percentage of the total trials,” said Alzheimer’s Association spokesman Niles Frantz.
In addition, federal funding of Alzheimer’s research nearly tripled from $503 million in 2012 to $1.8 billion (if the 2018 congressional appropriation becomes law), partly as a result of advocacy by the Alzheimer’s Association, said Dr. David Knopman of the Mayo Clinic and chair of the group’s Medical and Scientific Advisory Council. Even if those basic biology studies succeed, however, they wouldn’t lead to an effective drug in anything less than a decade.
As for the lack of outrage, “if someone has moderate to severe Alzheimer’s, there is a lot of therapeutic nihilism,” said Fillit. That is, families, caregivers, and even physicians have assimilated the decade-long drumbeat of drug failures. “Most people I see think there’s nothing that can be done and there’s no hope,” said Fillit, who disagrees with that grim assessment. They don’t handcuff themselves to the balcony of the stock exchange because they see no point.
An ethical issue also arises. For the most part, experimental drugs that have shown promise in early clinical trials, before ultimately failing, have merely slowed the rate of cognitive decline. That is, after 18 months on the experimental drug, patients’ scores on standard cognitive tests have fallen 30 percent less than have those of untreated patients. But they’ve still fallen. If a drug that achieves that in a Phase 3 trial (none has) were to win FDA approval, it would be a double-edged sword.
“At the end of 18 months, the patient is still going to be worse” than she was earlier, Fillit said, and it might take expert assessment to even detect that. Many scientists who study Alzheimer’s, as well as clinicians who treat it, therefore wonder if that’s a meaningful outcome, especially since slowing the rate of mental decline almost always means postponing the inevitable and living with a devastating disease for longer.
As for the one outlier in the exodus from drug development for advanced Alzheimer’s, last month Neurotrope said it had begun enrolling what it hopes will be 100 patients in a confirmatory Phase 2 clinical trial of bryostatin. All will have scores on the Mini Mental State Exam of 4 to 15 — moderate to severe Alzheimer’s — and scientists will be looking for signs that patients’ disease doesn’t merely stop worsening but that their cognition and memory improve. The company expects to complete the study around this time next year.
About the Author
Sharon Begley
Neurotrope Provides Business Update and Reports Second Quarter 2018 Financial Results
NEW YORK – August 13, 2018 – Neurotrope, Inc. (NASDAQ: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer’s disease (AD), today provided a business update outlining recent clinical development progress and other noteworthy events that occurred subsequent to the end of the quarter and unaudited financial results for the quarter ended June 30, 2018.
Clinical Development Highlights
On July 17, 2018, Neurotrope announced that it initiated enrollment of a confirmatory Phase 2 clinical trial in 100 moderate to severe AD (defined as a Mini Mental State Exam 2 score of 4-15). Patients will be randomized 1:1 to be treated with either Bryostatin-1 20ug, or placebo, receiving 7 doses over 12 weeks. Dosing has begun in the study, and we are anticipating completion of the study sometime during the third quarter of 2019. The study will be conducted at approximately 30 clinical trial sites.
Corporate Announcements
On July 25, 2018 at the Alzheimer’s Annual International Conference (AAIC) 2018 in Chicago, Neurotrope presented comprehensively analyzed data from its recent Phase 2 clinical trial. These new statistical data confirmed and extended previous analyses that Bryostatin caused AD patients, not on baseline memantine therapy, to improve more than 6.1 points over baseline and placebo in their Severe Impairment Battery (SIB) scores, in a pre-specified exploratory endpoint. This improvement persisted at least 30 days after all dosing was completed, as was confirmed with three different rigorous statistical analyses that were presented. These new analyses, together with many previous pre-clinical studies, suggest that Bryostatin can contribute to the anti-amyloid and anti-tau pathways as targeted by many other current company strategies, but may also uniquely engage natural pathways with regenerative benefits for the degenerating brain.
On July 11, 2018, the Company announced the formation of a Scientific Advisory Board being chaired by Dr. Martin Farlow, MD. Other members of the esteemed board are: Drs. Paul Coleman PhD; Daniel F Hanley Jr. MD; Marwan Subbagh, MD, and Lee Jen Wei, PhD.
"We believe that these Phase 2 study results presented at AAIC 2018 in July, suggest potential sustained clinical improvement not previously reported for moderate to severe AD patients. Extensive pre-clinical research suggested that Bryostatin not only activates natural enzymes in the human brain to degrade Amyloid beta and prevent abnormal tau, but we believe that it also activates natural enzymes to promote synaptic growth and prevent neuronal death. We believe that these multi-modal enzymatic effects, that include activation of well-known synaptic growth factors, may allow Bryostatin to not only slow down the cognitive decline of the disease, but it may also explain the increase in cognition,” said Dr. Charles Ryan, Chief Executive Officer of Neurotrope.
Second Quarter 2018 Financial Results (Unaudited)
As of June 30, 2018, the Company had approximately $11.8 million of cash and cash equivalents. The Company’s only significant financial commitments are the amounts due to Worldwide Clinical Trials for the recently initiated Phase 2 clinical trial of up to approximately $5.5 million. The Company has sufficient capital to complete such confirmatory Phase 2 clinical trial.
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 as a potential treatment for Stroke, Traumatic Brain Injury, and Fragile X Syndrome, Niemann-Pick Type C disease and Rett Syndrome—rare genetic diseases for which only symptomatic treatments are currently available. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X Syndrome. 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 in AD.
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. These statements are subject to the risk that further analyses of the Phase 2 data may lead to different interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company’s views of the Phase 2 data. 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
Jeffrey Benison, Director of Corporate Communications
Neurotrope, Inc.
516.286.6099 (C) or 212.334.8709 (O)
At AAIC 2018, Neurotrope Presents Additional Clinical Results Showing Cognitive Improvement in Phase 2 Data Assessing Bryostatin-1 in Moderate-to-Severe Alzheimer's Patients
NEW YORK, July 25, 2018 /PRNewswire/ -- Neurotrope, Inc. (NASDAQ: NTRP) today presented additional clinical results from its recently completed Phase 2 trial demonstrating that moderate-to-severe Alzheimer's disease (AD) patients treated with 20 µg Bryostatin-1 showed evidence of sustained improvement in cognition compared with placebo in patients not on concomitant memantine treatment, with a safety profile similar to placebo. The data and comprehensive statistical analysis are being presented in the Developing Topics Poster Presentation, "Significant Cognitive Improvement with Bryostatin for Advanced Alzheimer’s Patients in the Absence of Memantine" at the Alzheimer's Association International Conference 2018 in Chicago.
In preclinical studies Bryostatin-1 lowers beta amyloid levels by the activation of natural enzymatic pathways in the brain such as IDE, ECE and neprilysin. Bryostatin has also shown synaptogenesis and prevention of neuronal death in extensive pre-clinical studies by activating synaptic growth factors such as BDNF, IGF and NGF. Further data analysis of the recent Phase 2 trial results showed that advanced AD patients show improvement (> 6.0 points vs. placebo and baseline) in the Severe Impairment Battery (SIB) even 30 days after all drug dosing has been completed in patients not on memantine.
"Patients not on memantine treatment exhibited significant cognitive improvement, at all time points tested during the trial, as evidenced by the SIB scores, with an average of 6.1 point improvement (p=0.012) over baseline and placebo," stated Dr. Richard Thompson, Senior Statistician, Bloomberg School of Public Health, Johns Hopkins University. Dr. Thompson continued, "Various sensitive, comparative analyses were also conducted and resulted in consistent conclusions, including sustainability of the treatment effect over time, even 30 days after all dosing was completed."
In Neurotrope's previous Phase 2 trial of Bryostatin-1 for moderate-to-severe AD patients, Severe Impairment Battery (SIB) scores were consistently greater than baseline?, indicating improvement for patients treated with a specific dose regimen, (20 µg protocol). The magnitude of this SIB increase above baseline was much greater when a pre-specified exploratory analysis separated out patients who were not on standard of care memantine therapy. Patients not on memantine treatment exhibited an improvement of 6.1 points over baseline and placebo, in their SIB scores. This was confirmed using three different comprehensive statistical analyses detailed in the poster being presented. Patients dosed in the 20 µg group in combination with memantine background therapy, and the patients on placebo with donepezil background therapy, did not show an increase above the baseline score on the SIB scale.
"Because of the impressive improvement in the patients treated with the 20 µg dose of bryostatin who were not on memantine, Neurotrope has made the conservative decision to launch a confirmatory Phase 2 trial testing 100 moderate-to-severe AD patients with the 20µg dose of Bryostatin-1 in a 1:1 ratio versus placebo. We are delighted to have initiated enrollment of the study earlier this month," said Dr. Charles Ryan, Neurotrope Chief Executive Officer.
Preclinical findings by other labs confirm that memantine would likely block bryostatin’s observed improvement in cognition, due to their use of a shared cell signaling pathway. Both memantine and bryostatin engage the same receptor, the NMDA receptor. Memantine directly blocks the NMDA receptor. In the absence of memantine, bryostatin activates PKC, causing engagement of the NMDA receptor. These clinical study results validate Neurotrope’s proposed mechanism of action for bryostatin and its expected effects at a neuronal level, further bolstering the Company’s clinical program and informing the development of a pivotal trial protocol for Bryostatin-1 in moderate-to-severe AD patients.
The poster presentation information and a link to the poster is below.
Title Significant Cognitive Improvement with Bryostatin for Advanced Alzheimer’s Patients in the Absence of Memantine
(Poster presentationAbstract #27295)
Developing Topics Session: P4-199:
Date/Time Wednesday, July 25, 2018: 9:30 AM-4:15 PM CDT
Location Hall F1 - McCormick Place
Link to the poster
www.neurotropebioscience.com/wp-content/assets/NTRP Presentation AAIC 2018.pdf
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 as a potential treatment for Stroke, Traumatic Brain Injury, and Fragile X Syndrome, Niemann-Pick Type C disease and Rett Syndrome—rare genetic diseases for which only symptomatic treatments are currently available. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X Syndrome. 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 in AD.
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. These statements are subject to the risk that further analyses of the Phase 2 data may lead to different interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company’s views of the Phase 2 data. 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 March 31, 2018. The Company does not undertake to update these forward-looking statements.
Contact information:
Investors and Media
Jeffrey Benison, Director of Corporate Communications
Neurotrope, Inc.
516.286.6099 (C) or 212.334.8709 (O)
jbenison@neurotrope.com
Neurotrope Announces the Initiation of Enrollment of its Confirmatory Phase 2 Trial in Alzheimer's Disease
New York, July 16, 2018 /PR NEWSWIRE/-Neurotrope Inc. (NASDAQ: NTRP) a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer’s disease (AD), is announcing that the first patient has been enrolled into its confirmatory Phase 2 clinical trial with its lead Alzheimer's disease drug, Bryostatin-1. Patient recruitment will take place at approximately 30 clinical sites in the United States. This follow-on confirmatory clinical trial is planned to include 100 patients with moderate to severe AD (defined as a Mini Mental State Exam 2 score of 4-15). Patients will be randomized 1:1 to be treated with either Bryostatin-1 20ug or placebo, receiving 7 doses over 12 weeks. Patients on memantine, an NMDA receptor antagonist, will be excluded unless they have been discontinued from memantine treatment for a 30-day washout period prior to study enrollment. The primary efficacy endpoint is the change in the Severe Impairment Battery (SIB) score between the baseline and the average of weeks 13 and 15. In our previous Phase 2 trial, patients in the bryostatin 20ug dose group not receiving concurrent memantine treatment exhibited a SIB score improvement from baseline of over 6 points. There was no corresponding treatment effect for memantine-treated patients. Both bryostatin and memantine, an N-Methyl-D-aspartate (NMDA) receptor antagonist, engage the NMDA receptor. This convergence of memantine and PKC on the NMDA receptor may explain why patients who were not taking memantine during the trial exhibited a consistent cognitive improvement as measured by the SIB. In the absence of memantine, which blocks the NMDA receptor, bryostatin-activated PKC epsilon contributes to the regulation of this receptor.
"The potentially important persistence of the bryostatin-induced improvement in the SIB scores in our recently completed Phase 2 trial, even one month after completion of all dosing, is an effect that we hope to repeat in this confirmatory trial. Immunologic A Beta degradation has recently been the target of Biogen trials that appear to reduce the rate of cognitive decline in prodromal and early AD patients. Bryostatin's mechanism also contributes to the elimination of A Beta oligomers and amyloid plaques through activation of brain A Beta degradation enzymes. In addition, we believe the persistent reversal of cognitive decline in advanced AD patients may result from the multi-modal efficacies of bryostatin that include growth of new synapses and prevention of neuronal death. In late-stage AD patients in our phase 2 trial, bryostatin appeared to cause an increase in cognition – i.e. sustained improvement of SIB scores over baseline. Bryostatin’s sustained cognitive improvement is consistent with a long-lasting consequence of PKC epsilon-growth factor effects that could induce the growth and/or maturation of synaptic networks in the brain. Our hope is that this might translate into long lasting cognitive function benefit in advanced AD patients, and earlier stage patients," said Dr. Daniel Alkon, Neurotrope’s President and Chief Scientific Officer.
"Since February 2018, when I joined Neurotrope, I have reviewed a more extensive data set from the previous Phase 2 trial that gives me even more confidence that bryostatin had a positive effect on the patients in that study. I have also been receiving very positive feedback from key opinion leaders and I am very encouraged that this confirmatory Phase 2 study is initiating," said Dr. Charles S. Ryan, Chief Executive Officer of Neurotrope.
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 as a potential treatment for Stroke, Traumatic Brain Injury, and Fragile X Syndrome, Niemann-Pick Type C disease and Rett Syndrome—rare genetic diseases for which only symptomatic treatments are currently available. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X Syndrome. 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 in AD.
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. These statements are subject to the risk that further analyses of the Phase 2 data may lead to different interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company’s views of the Phase 2 data. 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 March 31, 2018. The Company does not undertake to update these forward-looking statements.
Contact information:
Investors and Media
Jeffrey Benison, Director of Corporate Communications
Neurotrope, Inc.
516.286.6099 (C) or 212.334.8709 (O)
jbenison@neurotrope.com
An Alzheimer's Candidate Has Garnered Optimism in Clinical Trials
https://www.genengnews.com/gen-articles/the-scoop-alzheimers-drug-tries-to-build-up-a-head-of-steam/6285
An Alzheimer's Candidate Has Garnered Optimism in Clinical Trials
In The Little Engine That Could, a plucky locomotive volunteers to haul a heavy train up a hill. The little engine whispers, “I hope I can I hope I can” at the hill’s base; rumbles, “I think I can I think I can” as it struggles up a steep slope; and exclaims, “I know I can I know I can” as it nears the top. Such optimism is hard to fault. Yet when it is expressed by a little biopharma as opposed to a little engine, many onlookers are inclined to say, “I doubt you can I doubt you can.”
A little biopharma called Neurotrope BioScience has been trying to build up a head of steam for its lead therapeutic candidate, an Alzheimer’s drug called bryostatin. Neurotrope, to judge by its announcements, sees itself somewhere between “I hope I can” and “Ithink I can.” Onlookers, however, express the sort of skepticism seldom seen in children’s stories, but common in drug development and the business press.
Last year, Neurotrope announced that it had positive top-line results from a Phase II trial of bryostatin in 147 patients with moderate to severe Alzheimer’s disease. Less rosy interpretations of the results were suggested by some analysts, and Neurotrope shares slumped. Undeterred, Neurotrope provided a follow-on analysis last January. According to the company, the new figures indicate that bryostatin is still on track.
“A post-hoc analysis of data from its Phase II trial in patients with advanced Alzheimer’s disease (AD) found evidence of improvement in cognition in patients receiving the 20-µg bryostatin regimen who did not receive memantine [Namemda], an approved AD treatment, as background therapy,” a Neurotrope press release noted. “The follow-on analysis also found that patients in the 20-µg treatment arm showed a sustained improvement in cognition over baseline compared to the placebo group at week 15 (30 days after last dose at week 11).”
“The discovery that an NMDA inhibitor like memantine may diminish the effect of bryostatin, a PKC epsilon activator, is very interesting,” commented George Perry, Ph.D., a neurobiologist at the University of Texas at San Antonio who recently joined Neurotrope’s board as a director. “It is consistent with the proposed mode of action of bryostatin, and provides an internal control within the trial.”
To find out where Neurotrope is headed next, GEN spoke to the company’s new CEO, Charles S. Ryan, J.D., Ph.D. “We’re planning a confirmatory Phase II clinical trial in a larger population of patients with advanced AD who are not taking Namenda as background therapy,” Dr. Ryan said. “We’ll remain focused on evaluating and developing bryostatin at the 20-µg dose with a study that will be designed and powered to incrementally confirm the cognitive increases previously observed.”
Dr. Ryan added that Neurotrope expects to begin the confirmatory study in the first half of 2018.
In the clinical work ahead, bryostatin may experience additional ups and downs. Regardless, the drug—a protein kinase C epsilon (PKCe) activator derived from a marine animal—can lay claim to an intriguing mechanism of action. “This molecule penetrates the blood-brain barrier to activate synaptic growth factors and thereby induce the production of new, mature synapses, activate signaling pathways that protect against neuronal death, reduce the levels of amyloid-beta oligomers, and thus reduce the production of extraneuronal amyloid plaques, prevent hyperphosphorylation of tau, and thus the generation of intraneuronal fibrillary tangles—and, through all of these mechanisms, potentially restore cognitive functions,” explained Dr. Ryan.
Neurotrope, then, emulates the Little Engine in two respects. It remains optimistic in the face of adversity, and it is willing to take on a challenge that might intimidate even large players. At a time when others have experienced significant setbacks in AD, said Dr. Ryan, Neurotrope is focusing on advanced AD patients. “Bryostatin,” he continued, “is the first PKCe modulator to be tested in a Phase II study in this population, which is notoriously difficult to treat, while virtually the entire industry is oriented toward treating mild to moderate AD and even mild cognitive impairment patients, 50% of whom never actually progress to AD.
“While current therapies on the market treat only the symptoms of AD, Neurotrope’s latest trial with bryostatin showed promising signs of sustained clinical benefit. The persistence of improved cognition one month after all dosing had been completed suggests that bryostatin has potential to treat the underlying cause of the disease as well as the progression of the disease.”
Jeffrey Benison
Neurotrope Bioscience
Director of Corporate Communications
(o) 212 334 8709 or (c) 516 286 6099
Neurotrope to Present at BIO CEO & Investor Conference
New York – February 7, 2018 – Neurotrope, Inc. (NASDAQ: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced that Daniel Alkon, MD, President and Chief Scientific Officer of Neurotrope, will present at the BIO CEO & Investor Conference to be held in New York City from February 12th-13th.
Management will be conducting 1-on-1 meetings during the conference. To arrange a meeting with Neurotrope, please contact Jeffrey Benison at the contact information below or utilize the conference’s partnering system https://www.bio.org/events/bio-ceo-investor-conference/partnering.
Title: BIO CEO & Investor Conference
Date/Time: Monday, February 12th, 2018 at 3:30 PM EST
Location: New York Marriott Marquis Hotel, New York City
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 as a potential treatment for Fragile X Syndrome, Stroke, Traumatic Brain Injury, and Niemann-Pick Type C disease and Rett Syndrome—rare genetic diseases for which only symptomatic treatments are currently available. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X Syndrome. 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 in AD.
Please visit www.neurotropebioscience.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. These statements are subject to the risk that further analyses of the Phase 2 data may lead to different interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company’s views of the Phase 2 data. 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, 2016 and on Form 10-Q for the quarter ending September 30, 2017. The Company does not undertake to update these forward-looking statements.
Contact information:
Investors
Jeffrey Benison, Director of Corporate Communications
Neurotrope Bioscience, Inc.
516.286.6099
jbenison@neurotropebioscience.com
Media
James Heins
Senior Vice President
ICR Healthcare
203.856.2121
james.heins@icrinc.com
Neurotrope to Present at NobleCon 14th Annual Institutional Investor Conference
Dr. Daniel Alkon, President & CSO, Joins Panel Discussion on Alzheimer’s Disease
New York – January 25th, 2018 – Neurotrope, Inc. (NASDAQ: NTRP), a clinical-stage biopharmaceutical company developing novel therapies for neurodegenerative diseases, including Alzheimer's disease (AD), today announced that Dr. Daniel Alkon, President and CSO, will provide a corporate overview at the NobleCon 14th Annual Institutional Investor Conference to be held at the W Hotel in Fort Lauderdale, FL from January 29th – 30th, 2018.
Neurotrope’s corporate presentation will take place on Tuesday, January 30th at 8:30 AM EST in Studio 2.
Dr. Alkon will also participate in a panel discussion entitled "Central Nervous System: Is there a cure for Alzheimer's on the Horizon?" on Monday, January 29th at 9:00 AM EST in Studio 1 of the W Hotel.
A video webcast of Neurotrope’s presentation will be available here and on the Company’s web site at www.neurotropebioscience.com. The video webcast will be archived on Neurotrope’s website following the event.
About Bryostatin
Bryostatin-1 is a protein kinase C epsilon (PKC?) activator that works through synaptic growth factors, as well as anti-amyloid and anti-tangle signaling pathways in the brain. It has been shown in preclinical efficacy studies to induce the growth of mature synapses in the brain and prevent neuronal death. Thus, Bryostatin-1 introduces a fundamentally different biological mechanism of action with the potential for longer lasting effects than the other currently available therapies. Bryostatin-1 is the first PKCe modulator to be tested in a phase 2 clinical study for patients suffering from moderate to severe AD — a difficult to treat population.
The rationale for researching this novel mechanism in AD results from in vitro and in vivo models of AD demonstrating that modulation of PKCe by Bryostatin-1 enhances synaptogenesis and prevents neuronal death. As synaptic loss is tightly correlated with cognitive impairment in AD, this attribute of the molecule made bryostatin an intriguing candidate for additional investigation in dementia. Furthermore, preclinical studies also demonstrated bryostatin reduces toxic Aß levels, prevents plaque formation, inhibits tau phosphorylation, and enhances cognition. Thus, the multimodal effects of this first PKCe modulator offer a potential new mechanism to study in AD with the ultimate goal to slow or prevent the progression of disease.
About Neurotrope
Neurotrope is at the forefront of developing a new approach to combatting 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 moderate to severe AD, Neurotrope has also conducted preclinical studies of bryostatin as a potential treatment for Fragile X Syndrome, Niemann-Pick Type C disease and Rett Syndrome—three rare genetic diseases for which only symptomatic treatments are currently available. The FDA has granted Orphan Drug Designation to Neurotrope for Bryostatin-1 as a treatment for Fragile X Syndrome. 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 in AD.
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. These statements are subject to the risk that further analyses of the Phase 2 data may lead to different interpretations of the data than the analyses conducted to date and/or may identify important implications of the Phase 2 data that are not reflected in these statements. Clinical trial data are subject to differing interpretations, and regulatory agencies, medical and scientific experts and others may not share the Company’s views of the Phase 2 data. 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, 2016 and on Form 10-Q for the quarter ending September 30, 2017. The Company does not undertake to update these forward-looking statements.
Please visit www.neurotropebioscience.com for further information.
Contact information:
Investors
Jeffrey Benison
Director of Corporate Communications
Neurotrope Bioscience, Inc.
516.286.6099
jbenison@neurotropebioscience.com
Media
James Heins
Senior Vice President
ICR Healthcare
203.856.2121
james.heins@icrinc.com
Halted
yes.
How Close Are We to Finding a Treatment for Alzheimer's?
Read the article below. Most of the companies that are in phase 3 are either antibodies targeting plaque that attempt to slow the progression of the disease, or companies with drugs that failed phase 2 studies. After the companies went through the data they found their drug worked better in a subset of patients, so they are targeting that subset in their new study even if there is no scientific rationale to do so, based on the mechanism of action.
Neurotrope just released data showing, that in the study using bryostatin the patients on the very safe dose of the drug, increased cognition in those patients, while patients on the standard of care declined, just as would be expected.
I am getting a lot of questions about the stock performance and why it is going down. There were 5 late stage oral presentations accepted by the AAIC conference and our bryostatin study was one of them. There were 3 trials in severe Alzheimer's patients with data presented at the conference. The bryostatin trial was one of them, the other two were studies testing Aricept and Namenda. Neurotrope is the only company testing patients in the largest healthcare unmet medical need, in the toughest patient population that can be tested in that disease. We had a positive trial in those patients, with the data being presented by a top key opinion leader in the field, Dr. Martin Farlow. If the drug shows an effect in those patients, our belief is that it would show a larger effect in milder patients.
Here is a link to the slide deck from the AAIC 2017 conference
http://www.neurotropebioscience.com/Welcome_to_Neurotrope_BioScience/HomePage-Forms/AAICF.pdf
I can be reached at 516 286 6099 if you would like to discuss this
How Close Are We to Finding a Treatment for Alzheimer's? .
CLEVELAND CLINIC
1 gün önce 9 Views
A nurse holds the hands of a person suffering from Alzheimer's disease.
A nurse holds the hands of a person suffering from Alzheimer's disease.
(Photo: Sebastien Bozon/AFP/Getty Images)
There are about 30 drugs for Alzheimer's disease now in Phase III clinical trials—the last set of experiments drug companies must run to prove their product is safe and effective before obtaining Food and Drug Administration approval.
But don't be fooled by press releases like this one, touting "27 Phase III ... Alzheimer's drugs on track to launch in the next five years." Judging from past Alzheimer's drugs' success, it's unlikely many—if any—of these medicines will make it to market. In 2014, researchers found that, out of 244 Alzheimer's treatments that were deemed promising enough to test in clinical trials between 2002 and 2012, only one made it to market. That's a failure rate of 99.6 percent. In contrast, the general failure rate for pharmaceuticals as a whole is an estimated 89.6 percent.
"The pipeline for Alzheimer's disease is pretty poor," says Aaron Ritter, a doctor at the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, and a member of a team that surveyed developing Alzheimer's drugs in 2016 and 2017. The team's latest survey was published in the September issue of the journalAlzheimer's & Dementia.
"If we think that 99 percent of those is going to fail, that doesn't give us much of a chance to reach our goal of finding some meaningful treatment by 2025," Ritter says.
"The pipeline for Alzheimer's disease is pretty poor."
The 2025 date comes from both the National Plan to Address Alzheimer's Disease, which officials originallypublished in 2012, and a 2013 meeting of the G8 countries about dementias, which include Alzheimer's as well as other memory-loss conditions. Why 2025? "A lot of the epidemiology work says that, if we don't find better cures by 2025, that, in 2050, the health economies are not going to be able to handle the number of people living with Alzheimer's disease," Ritter says. One study, based on 2010 numbers, estimated that 13.8 million Americans will have Alzheimer's dementia by 2050 if no better therapies are found. Dementias may cost America more than $1 trillion by 2050, the Alzheimer's Association estimates.
The United States' National Alzheimer's Project Act of 2011 helped speed the search for treatments somewhat by funneling federal money into research and encouraging scientists to collaborate and share data, Ritter thinks. Still, it doesn't seem to be enough.
Ritter and his team hope to publish surveys on Alzheimer's drugs every year, to help other scientists identify gaps in the science. In the researchers' papers, they identify why they think Alzheimer's cures are so hard to find. Speaking to Pacific Standard, Ritter mentions a few related reasons. Alzheimer's disease is difficult to study because it develops over many years, he says; from a pharmaceutical company's point of view, that means longer-lasting, more expensive clinical trials than for the typical drug. In addition, many medical mysteries remain about what, exactly, causes Alzheimer's symptoms and what anti-Alzheimer's drugs should target in the brain. "So if you take that idea to an investor, there's not a lot of people that are willing to jump in and get involved," Ritter says.
Ritter and others propose finding new ways to fund Alzheimer's research, perhaps by combining money fromgovernments and drug companies. And what can folks at home do to support the search for a cure? Ritter suggests volunteering for clinical trials about Alzheimer's disease and voting for politicians who support funding biomedical research.
Source:
Google Uyari - Cleveland Clinic
I GOT AN EMAIL ALSO.
i emailed asking if show was on. got this response
We have nothing confirmed on the docket
Jeffrey Benison
Neurotrope Bioscience
Director of Corporate Communications
(o) 212 334 8709 or (c) 516 286 6099
That looks almost like the stuff i bought on amazon months ago
PlusCBD oil by CannaVest (from seed to shelf)
http://cannavest.com/
No Problem, My email alerts just went crazy and then the After hours price shot up after the news. 16:09($ 11 High )
Well thank you for posting info about this Awesome stock!!! which led me to buy!! Cheers!!
NQ Mobile Inc (ADR) : NQ Mobile(TM) Expects Second Quarter 2013 Revenues to Exceed $40 Million, Above The Previously Announced Revenue Guidance Range Of $38.5 -- $38.8 Million
07/15/2013 | 04:05pm US/Eastern
Recommend:
0
BEIJING and DALLAS, July 15, 2013 /PRNewswire/ -- NQ Mobile Inc. (NYSE: NQ) (NQ Mobile), a leading global provider of mobile Internet services, today provides its preliminary second quarter 2013 revenue guidance. The company now estimates that its overall revenues for the second quarter 2013 will exceed $40 million. The company will provide final second quarter 2013 results during its regularly scheduled earnings conference in mid-August.
(Logo: http://photos.prnewswire.com/prnh/20121224/CN34262LOGO)
Also, the company announces that it has entered into a share purchase agreement to acquire the remaining 45 percent stake in its subsidiary, Beijing NationSky Network Technology, Inc. (NationSky), and fully consolidate the two businesses. This transaction is expected to be accretive to earnings in the third quarter 2013 as both the revenue growth and profitability trends of NationSky are exceeding the company's original targets.
The total cash and stock consideration for the NationSky purchase is valued at $25.2 million. The consideration includes $11 million in cash and $14.2 million in the company's Class A common shares. There will be additional performance-based consideration provided that certain profitability targets are met over the next 18 months.
"Our businesses are performing extremely well. With our updated second quarter 2013 revenue outlook, it is clear that our strategy to monetize our growing user base is taking hold. Our excitement is only increasing as we look towards the future of our business," said Co-CEO, Omar Khan. "The purchase of the remaining 45 percent of NationSky is also an exciting development. NationSky is well positioned to leverage the explosive global growth in enterprise mobility solutions. The bring-your-own-device (BYOD) trends within the enterprise are blending the individual consumer's desires with the demands of the enterprise environment. By fully integrating our business with that of NationSky, NQ Mobile is uniquely positioned as a global mobility solutions and services provider."
"Mobility trends are changing the way enterprises work. NationSky has successfully positioned itself in targeting the enterprise mobility market. The NationSky business has exceeded our expectations since we purchased a controlling 55 percent in NationSky in early 2012," said the Co-Founder and Co-CEO of NQ Mobile, Dr. Henry Lin. "We are excited to be in a position to fully consolidate NationSky's businesses and better reap the rewards of NationSky's rapidly advancing enterprise mobility business. We believe that our shareholders will benefit from the financial and strategic value of this deal."
NationSky currently has more than 1,250 large enterprise customers including banks, brokers, insurance and healthcare companies. Many of these companies are Fortune 500 companies. NationSky has become a tier-1 partner of Apple and Lenovo products and solutions to enterprise customers.
"I am excited to complete the integration with NQ Mobile," said the CEO of NationSky, Charlie Hou. "NQ Mobile provides industry-leading products and services which, when combined with NationSky's enterprise customer base, will drive our leadership in enterprise mobility in China."
The company will host a conference call today at 5:00 p.m. EDT to further discuss the details of this transaction and the related financial and strategic implications. The dial-in information for the call is set forth below. Additionally, a presentation for the conference call is located under the Investors Relations section of the Company's website at ir.nq.com.
The dial-in details for the conference call are:
U.S. Toll Free: 1 866 519 4004?
International: +1 718 354 1231?
Hong Kong: +852 2475 0994?
United Kingdom: +44 2030598139?
China Mainland: 400 620 8038 or 800 819 0121?
Conference ID # 19520132
Please dial in 10 minutes before the call is scheduled to begin and provide the conference ID to join the call.
About NationSky
NationSky is a leading enterprise mobile services provider headquartered in Beijing, China. Founded in 2005, NationSky provides device agnostic managed mobile services, mobile device management services and other mobile SaaS offerings to over 1,250 enterprise customers in China in a wide range of industries, including IT, manufacturing, finance, energy, healthcare. NationSky enables employees to access the back-end enterprise office system when conducting business activities such as emailing, communication, project planning and more. The current business portfolio covers enterprises services based on platforms such as Apple iOS, BlackBerry and Android. NationsSky also possesses a strong relationship with wireless carriers, such as China Mobile, and provide relevant distribution and maintenance services
Yes!!! GO BIDU