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Remember the news about second hand smoke on airlines and stewardesses who had less Parkinson's than the general population, ---anatabine citrate in tobacco. Same MO
Pineapple Pesticide Linked to Parkinson's Disease in NBC Health, MAGGIE FOX, DEC 9 2015
Excerpts:
"It's known the milk in Hawaii was contaminated, probably from the feed given to the cattle. "The researchers could not test whether the milk the men drank was contaminated with pesticides (heptachlor, in this case), and no one knows how long or how widespread the contamination was before being detected," the Parkinson's Disease Foundation said in a statement on its website.
"The potential link between drinking milk, pesticides and development of Parkinson's disease needs further investigation," the foundation said.
The men who smoked and who also drank milk showed none of the brain cell loss."
Article at:
http://www.nbcnews.com/health/health-news/pineapple-pesticide-linked-parkinsons-disease-n477346
Chronology of Anatabine---Rock Creek Pharmaceuticals - Updated timeline: Tobacco > Nicotine > Anatabine > Anatabloc, Onthemarket
Oct 22, 2014
Article at:
http://www.smallcapnetwork.com/Rock-Creek-Pharmaceuticals-Updated-timeline-Tobacco-Nicotine-Anatabine-Anatabloc/s/via/8996/article/view/p/mid/1/id/149/
The "Holy Grail" of Medicine--worth repeating again, especially those new to RCPI, Patrick Cox, JULY 18, 2011
Excerpts:
"The name of the neural circuit that regulates the immune response to injury and invasion is the “inflammatory reflex.” Inflammation is a complex mechanism that involves the destruction of damaged cells. It heals salvageable cells and aids in the growth of entirely new cells.
When we are young, the primary role of this important biological response is to heal injury or infection. But inflammation also increases the rate of aging and leads to various pathologies.
Chronic inflammation increases as you age. Eventually, it creates a problem serious enough to trigger a cascade effect. Uncontrolled inflammation causes the simultaneous healing and destruction of cells.
This can lead to: cancers, heart attacks, lupus, IBS, macular degeneration, stroke, obesity, ED, allergies, psoriasis, Crohn’s disease, endometriosis, rheumatoid arthritis, hair loss, diseases of the organs such as the thyroid and liver as well as…
Well, you name it.
Today, scientists have advanced the science much further. Many are now using the term “inflammaging,” coined by Claudio Franceschi, professor of immunology at the University of Bologna.
It appears that our immune systems react to the normal effects of aging as if they were injuries. This initiates inflammation, an immune response. This inflammation causes cellular stress. It is, by definition, an auto- immune disorder. Some scientists call it auto[innate]immunity subclinical syndrome.
It is a vicious circle, a chronic cycle that spins faster and faster until the organism itself eventually fails. Aging, we now know, is not linear. Like so many other things, it is a process that accelerates over time.
However, if there were a way to stop chronic low-level inflammation we could put the breaks on the auto-immune inflammation cycle. If we could stop chronic low-level inflammation. Our bodies could heal naturally.
We would even see cells damaged by past inflammation-related diseases heal normally. We’re not talking about regenerative medicine.
Regenerative medicine promises to replace aged cells and tissue with young telomere-restored cells and tissue. An alternative route is the activation of the telomerase gene, which we know can restore telomeres to youthful lengths.
In the meantime, however, we need to slow the process of telomere loss. For some time, scientists have known that inflammation is the primary accelerator of telomere loss. This is why so few of us reach our theoretical maximum life spans – which could be 120 years or more.
We would be much, much more likely to reach that theoretical upper limit if we aged as we did when we were young. A drug that actually controlled inflammaging would restore the aging process to a more linear progression.
For this reason, many scientists are looking for the means to reduce or stop inflammaging. Not infrequently, this hypothetical drug has been referred to as the “holy grail” of drug discovery.
The market for such a compound would be so big it is nearly unimaginable. Lipitor, technically atorvastatin, does lower indicators of inflammation. The most well-known, because doctors can test for it easily, is C-reactive protein (CRP). CRP levels rise with inflammation and their reduction demonstrates lowered inflammation. As a result, Lipitor is known to reduce the danger of cardiovascular and other diseases for many people.
Measured by sales, Lipitor is the most successful drug in history. Last year, Pfizer sold over $5 billion of Lipitor. This is despite a broad range of adverse effects and competing anti-inflammatory statins. At its peak in 2006, Pfizer was earning almost $13 billion annually from Lipitor.
But the breakthrough nutraceutical I mentioned above is far more effective than Lipitor or the other statins while being safer and cheaper. That, my friends, is the holy grail of modern medicine so many scientists are seeking.
More unbelievable still, they’re saying it isn’t even a drug in the legal sense. The holy grail is an extremely safe nutraceutical – a food that all of us consume in small quantities regularly."
Article at:
http://dailyreckoning.com/the-holy-grail-of-medicine/
Alzheimer's: A Disease On Track to Bankrupt Medicare, CNBC.COM, NOV 10 2015
Excerpts:
"Leading Alzheimer's researchers are optimistic that effective treatments to significantly slow or even halt the symptoms of this agonizing and ultimately fatal disease will be available within the next 5 years."
"According to the Alzheimer's Association, there are now 5.3 million Americans age 65 and older living with the disease. The total direct cost to the U.S. economy of caring for those with Alzheimer's: a staggering $226 billion, with half being borne by Medicare.
Delaying the onset of the disease by just five years, research studies show, could decrease Medicare spending by 50 percent. That's an important point to consider, because economists forecast that unless something is done to cure or even slow the symptoms, the number of people with Alzheimer's will rise to 16 million by 2050 and cost the U.S. economy $1.1 trillion. The portion covered by Medicare will balloon to $589 billion."
"The FDA-approved drugs now on the market and most widely prescribed to treat Alzheimer's — Aricept and Namenda — are helpful but limited, doctors say. "What's available now are symptomatic treatments that simply give a patient maybe six to 12 months of doing just a little bit better," says Dr. Reisa Sperling, a leading Alzheimer's researcher and professor of neurology at Harvard Medical School. Even the newest drug on the market — Namzaric — is basically a combination of two existing drugs and claims only to slow the worsening of symptoms for a while. Like Aricept and Namenda, Namzaric has no effect on stopping or preventing the underlying disease."
"Researchers say the work being done today could bring about a host of new drugs to treat the disease better and more effectively than anything currently on the market. These new therapies could potentially stop the progression of the disease before symptoms, like memory loss and confusion, ever start — something that's not possible with the drugs now being prescribed.
These findings have ignited renewed interest in other cognitive culprits; chief among them is another brain protein, called tau. Unlike beta-amyloid, which forms and builds up outside the neurons in the brain, tau develops inside the neurons. From there it can do its damage by traveling to neighboring cells and acting as a sort of virus that corrupts the normal protein of these other cells. For this reason, researchers believe tau may play an even more direct and influential role than beta-amyloid in the development of Alzheimer's and other forms of dementia.
Diamond of the University of Texas describes the relationship between these two proteins this way: "If [beta-amyloid] unlocks the barn door and let's the tau out, then tau is the horse that goes running off," he says. "It's the progression of tau as it moves through your brain that actually causes Alzheimer's dementia, but it's the [beta-amyloid] that sets you up to get that pathology.""
Article at:
http://www.nbcnews.com/health/aging/alzheimers-disease-track-bankrupt-medicare-n460651
Reference re anatabine citrate:
Anatabine Attenuates Tau Phosphorylation and Oligomerization in P301S Tau Transgenic Mice
Abstract:
"We have previously shown that the natural alkaloid anatabine displays some anti-inflammatory and Alzheimer amyloid (Aß) lowering properties in the central nervous system associated with reduced STAT3 and NFkB activation. We investigated here the impact of a chronic oral treatment with anatabine in a model of tauopathy. We found that anatabine reduces the incidence of paralysis and abnormal hind limb extension reflex while improving rotarod performances in P301S mutant human Tau transgenic mice (Tg Tau P301S) suggesting that anatabine delays the disease progression in this model of tauopathy. Analyzes of brain and spinal cord homogenates reveal that anatabine reduces tau phosphorylation at multiple pertinent Alzheimer’s disease (AD) epitopes and decreases the levels of pathological tau conformers/oligomers in both detergent soluble and insoluble fractions. Pathological tau species reduction induced by anatabine was accompanied by decreased Iba1 expression suggesting a diminution of microgliosis in the brain and spinal cord of Tg Tau P301S mice. In addition, we found that anatabine administration increases phosphorylation of the inhibitory residue (Ser9) of glycogen synthase kinase-3ß, a primary tau kinase, associated with AD pathology, providing a possible mechanism for the observed reduction of tau phosphorylation. These data support further exploration of anatabine as a possible disease modifying agent for neurodegenerative tauopathies and, in particular AD, since anatabine also displays Aß lowering properties"
http://www.researchgate.net/publication/263198861_Anatabine_Attenuates_Tau_Phosphorylation_and_Oligomerization_in_P301S_Tau_Transgenic_Mice
The Anti-Aging Groundswell, PATRICK COX DECEMBER 4, 2015
My comments: Anatabine Citrate coming to a Gerontologist near you. Question is when?
The newsletter:
"Dear Reader,
I really hope you were able to watch the National Geographic documentary, The Age of Aging, as I suggested. I’ve been predicting a fundamental transformation in the way that the public, especially the baby-boom generation, views health care and the regulatory process. This documentary is powerful evidence that this revolutionary change is well underway and accelerating.
If you’ve been reading me, you probably already know most of the specific information about aging that was presented in the show. The critical, historic aspect about the documentary, however, is that it was even made. If you subscribe to some network that includes the series, you can access it online or sign in here to watch the program.
The program was nearly perfect for investors and those who want to see health care brought into the 21st century. In addition to Brian Kennedy, CEO of the Buck Institute, the other scientists involved in the production were of sterling caliber and reputation. This includes S. Jay Olshansky, PhD, Nir Barzilai, MD, Simon Melov, PhD, James Kirkland, MD, PhD, Cynthia Kenyon, PhD, and others.
The documentary itself is what you’d expect from National Geographic and director Ron Howard. Moreover, the National Geographic Channel perfectly hits the wealthier, older demographic that needs to hear this message. And that message is simple: When it comes to health care, we’ve been doing it wrong.
Several of the scientists featured in the program admit that the search for “a fountain of youth” is tarnished by a history of fraud and dashed expectations. What’s different today, though, is that science has uncovered mechanisms that modulate aging as well as substances that extend healthy life in animals. Based on a surprising amount of preliminary human data, these substances are expected to do the same in the people. The evidence is presented calmly and persuasively.
The fact that this documentary exists makes my job easier because most people don’t understand how much the scientific consensus has shifted. In recent years, the community of researchers who investigate aging has become increasingly convinced that we can delay the biological glitches that accelerate the aging process and bring on specific diseases.
Unfortunately, our regulatory system still focuses solely on treating the results of aging after they have occurred. As one of the scientists in the documentary pointed out, we have essentially transferred the medical model developed to treat infectious diseases to the diseases of aging… and it doesn’t work.
As a group, biogerontologists have been saying this for several years, but the general population is unaware of the fact that aging can be treated, thus delaying or preventing the diseases that arise when complex metabolic systems begin to malfunction. These ailments include all the big killers of our era, including heart disease, stroke, cancer, Alzheimer’s, and others.
The heart of the show is an important news event, the effort headed up by Dr. Nir Barzilai of the Albert Einstein College of Medicine to get FDA approval for clinical trials that would test the widely used diabetes drug metformin as an anti-aging therapy.
I told you about that meeting with the FDA when it was happening, but more people need to understand the promise embodied in metformin. Besides numerous studies showing that metformin extends health spans in animals, the human data is compelling. Though type-2 diabetes will shorten a person’s life by about eight years if untreated, a British observational study of about 150,000 people showed that diabetics who take metformin have a 17% lower rate of mortality and significantly outlive the general population.
Of critical importance was Barzilai’s statement in the program: “We’re sure of the science. Metformin may not be the ultimate drug, but it’s a tool—generic, cheap, and safe. We want to show that we’re going to slow the rate of aging.”
Then, scientists agree, other, more effective anti-aging drugs could be approved. I’ve told you about some of these superior anti-aging technologies, but there some I can’t talk about yet. This is a critical area of research for me because these biotechnologies are going to have a massive impact in areas from health care to homeownership.
Once the regulatory path for an anti-aging drug becomes established, the pharmaceutical industry will be able to develop drugs to prevent diseases, just as it has developed drugs to treat diseases. Another interesting aspect of the documentary is that it seems to have been consciously written to encourage the FDA to approve the metformin trials.
The tenor of the show is non-confrontational, but it clearly and politely paints the FDA into a corner, challenging the government and regulators to do the right thing and lessen both the costs and suffering associated with premature aging. While the meeting with the regulators couldn’t be filmed, the deputy director of the FDA, Robert Temple, MD, was interviewed afterward, and what he said was encouraging.
Following the meeting, a beaming Barzilai said on camera, “We always thought the Promised Land wasn’t in our reach. And I think we are going to the Promised Land. The fact that the FDA is going to be positive is really a major achievement.” Biogerontologist and author Steven Austad, PhD, who attended the meeting, described the FDA as “very receptive.”
A significant part of the show was dedicated to explaining that even a marginal slowing of aging in humans would yield monumental effects. Video was shown of a meeting with Claire McCaskill of Missouri, the ranking member of the Senate Aging Committee. She clearly understood the message brought to her by the scientists supporting the metformin trial.
Specifically, she stated that people don’t realize that delaying the onset of adult diabetes would be enough to get the US out of debt. Therefore, an across-the-board delay in aging would do much more. “Of course the train wreck is coming,” she said, adding that the demographic bubble threatens “all of our government programs.”
This, of course, is true. While she described anti-aging medicine as a way to avoid the budgetary train wreck, Brian Kennedy was clearest in describing the existential threat aging poses for our economy and society: “The world’s rapidly getting older. There’s not going to be enough people working to pay for all the older people… I hope we look back on this era and say, ‘Wow, the medical community was on top of this, and they developed interventions that kept everybody healthy longer, prevented these diseases, lowered healthcare costs, and kept the world economy growing.’”
I think even Kennedy understated the urgency of this challenge, though. Just as most people seem to avoid thinking of their own age-related morbidity and mortality, society as a whole is not yet facing the consequences of the aging demographic. Already, however, we’re nearly maxed out on the national credit card, with the direct debt jumping to about $19 trillion in the last few months. The largest component of the budget and therefore the debt is, in fact, transfer payments to the aged.
That’s why I think Barzilai and others may underestimate the pace of this transformation. If the problem of aging is not solved, we face outcomes similar to those suffered by Japan and Greece. The extraordinarily homogenous Japanese society is struggling to deal with the deterioration of the country’s economy due to the burden of an aged population. The Greek budget is similarly stressed by unpayable entitlements for its aged, but the breakdown is even more obvious there.
The West’s governments will come to grips with this problem—and the potential to solve it via biotechnologies—because politicians, desperate to keep tax revenues flowing, will accelerate the transformation of health care to satisfy aging voters and younger taxpayers alike. Many of the anti-aging scientists in the program were optimistic about a transition to anti-aging health care. Olshansky observed that “there’s a lot of excitement in the field. Now we can feel traction. We can feel that people are coming on board.”
I saw some evidence of this change after the documentary was aired. On the Drudge Report, the single most important website for journalists, a story about the metformin effort titled, “Anti-ageing drug could let you live to 120 in good health” was featured for days. Other stories elsewhere made the same claim.
While I don’t believe that metformin alone will achieve those results, that kind of press coverage is a sign of the accelerating transformation. And maybe some combination of anti-aging therapeutics will get people extremely close to their approximately 120-year Hayflick Limit.
I find it extremely interesting, by the way, that the primary side effect of the currently approved form of rapamycin, Sirolimus, is diabetes-like symptoms. So it’s natural to wonder what a combination of a rapamycin analog combined with the diabetes drug metformin would do.
As I write this, some news sources are claiming that the FDA has approved the trial. More information will be available soon, I’m sure. Once again, you can access The Age of Aging using your network subscriber information here.
If you want to learn more about my ongoing research into anti-aging biotech breakthroughs (and how to profit from them), give my monthly advisory, Transformation Technology Alert, a risk-free try today.
Sincerely,
Patrick Cox
Patrick Cox
Editor, Transformational Technology Alert"
Newsletter at:
http://www.mauldineconomics.com/tech/tech-digest/the-anti-aging-groundswell
Old news dated: April 8, 2014
Did you notice this?
Drug stock soars 400% after Martin Shkreli buys it in 'CNN Money', Paul R. La Monica, November 20, 205
Excerpts:
"
Remember Martin Shkrekeli? The hedge fund manager turned pharmaceutical executive who became the center of a debate on drug prices after his firm Turing raised the cost of a drug used by AIDS patients by over 5,000% from $13.50 a pill to $750?
Well, he just bought a majority stake in another drug company ... and shares of it surged 400% on the news."
My cmments: Shkreli was the greedy guy who hiked the price of Daraprim by 5,500%.
Article at:
http://money.cnn.com/2015/11/19/investing/martin-shkreli-turing-kalobios-drug/index.html
RCPI Maxim Group Equity Research, Jason Kolbert, Jason McCarthy, Ph.D.
Article:
Rock Creek Pharmaceuticals Buy
3Q Results and Clinical Study Update
Summary
• Rock Creek reported 3Q with a net loss of approximately $2.8M or ($0.26) per
share. The monthly burn rate was about $1M. We recently launched coverage
on the company with a Buy Rating, a $4 price target, and the theme "taking a
successful nutraceutical to the clinic."
• The company completed its ex-U.S., three-part Phase I study (an oral
formulation of anatabine citrate) for the treatment of mild to moderate
psoriasis. The trial was conducted with healthy volunteers and demonstrated
both tolerance and a strong safety profile (with no adverse events reported).
• The company is conducting the final analysis on the Phase I clinical data
(expected by year end), with a follow-up Phase 1b proof-of-concept trial in
1H16. Recall that Rock Creek's regulatory strategy is to complete a single-site
Phase Ib/IIa trial in EU and prepare data for a multi-site Phase IIb trial including
in the U.S. The FDA's approval for the Phase IIb trial is expected in 2016.
• Bottom line: Large amounts of established user data (reports from
the Anatabloc users) support the compound's effectiveness as an antiinflammatory
and mitigates much of the risk associated with the product. We
see psoriasis (an inflammatory disease manifesting in the skin) as the first of
multiple possible indications — the "low-hanging fruit" opportunity.
Details
• Anatabine citrate, Rock Creek's lead product candidate is a synthetic derivative
of the anti-inflammatory compound anatabine (from the tobacco plant), and it is
in clinical development for the treatment of psoriasis. Anatabine was a successful
nutraceutical ("Anatabloc") used by more than 500,000 people, primarily to
alleviate inflammation conditions such as osteoarthritis. Anecdotal evidence has
also supported anatabine citrate being used in psoriasis.
• Anatabine citrate targets two key inflammatory pathways. It is a small
molecule with anti-inflammatory properties that binds to cholinergic receptors
on the surface of immune cells and shuts down the signaling pathways
responsible for driving inflammation. Anatabine citrate's binding and suppression
of inflammation is unique in that it effectively suppresses two key mediators
of inflammation, the transcription factors NF-kB and STAT3, while many other
drugs only suppress one or the other. NF-kB and STAT3 drive the expression
of damaging inflammatory cytokines like TNF-alpha, which is the target of
blockbuster drugs like Humira, Remicade, and Enbrel. We see psoriasis as an
ideal initial indication for anatabine citrate. We believe that anatabine citrate
efficacy should be relatively easy to observe through changes in skin lesions as
measured by the PASI (Psoriasis Area Severity Index) scoring system.
• Conclusion. Our current assumption is that anatabine citrate is approved and
launched by 2020. We believe the success of the prior nutraceutical form of
anatabine as an anti-inflammatory in more than 500K users partially mitigates risk.
Nevertheless, we apply a discount rate of 30% to our free-cash-flow, discountedEPS,
and sum-of-the-parts models, which are equally weighted to derive a $4
price target.
SEE PAGES 3 - 4 FOR IMPORTANT DISCLOSURE
No link, from Maxun enail, probably available on Maxim website.
What Is Autism? in 'Autism Speaks'
Excerpts:
" Autism spectrum disorder (ASD) and autism are both general terms for a group of complex disorders of brain development. These disorders are characterized, in varying degrees, by difficulties in social interaction, verbal and nonverbal communication and repetitive behaviors. With the May 2013 publication of the DSM-5 diagnostic manual, all autism disorders were merged into one umbrella diagnosis of ASD. Previously, they were recognized as distinct subtypes, including autistic disorder, childhood disintegrative disorder, pervasive developmental disorder-not otherwise specified (PDD-NOS) and Asperger syndrome.
ASD can be associated with intellectual disability, difficulties in motor coordination and attention and physical health issues such as sleep and gastrointestinal disturbances. Some persons with ASD excel in visual skills, music, math and art."
"Autism statistics from the U.S. Centers for Disease Control and Prevention (CDC) identify around 1 in 68 American children as on the autism spectrum–a ten-fold increase in prevalence in 40 years. Careful research shows that this increase is only partly explained by improved diagnosis and awareness. Studies also show that autism is four to five times more common among boys than girls. An estimated 1 out of 42 boys and 1 in 189 girls are diagnosed with autism in the United States.
ASD affects over 3 million individuals in the U.S. and tens of millions worldwide. Moreover, government autism statistics suggest that prevalence rates have increased 10 to 17 percent annually in recent years. There is no established explanation for this continuing increase, although improved diagnosis and environmental influences are two reasons often considered."
"Did you know ...
Autism now affects 1 in 68 children and 1 in 42 boys
Autism prevalence figures are growing
Autism is one of the fastest-growing developmental disorders in the U.S.
Autism costs a family $60,000 a year on average
Boys are nearly five times more likely than girls to have autism
There is no medical detection or cure for autism
National Institutes of Health Funds Allocation
Total 2012 NIH budget: $30.86 billion
Of this, only $169 million goes directly to autism research. This represents 0.55% of total NIH funding."
Article at:
https://www.autismspeaks.org/what-autism
Emerging interest in neuroinflammation as a treatment target for Alzheimer's disease in 'Medical News Today', 9 November 2015
Excerpts:
"Renewed interest in the role of neuroinflammation as a driver of Alzheimer's disease (AD), and its potential as a therapeutic target, took center stage at the 8th International Conference on Clinical Trials for Alzheimer's Disease (CTAD). According to Richard Margolin, M.D., of CereSpir, Inc., while neuroinflammation has long been suspected as an important player in the pathogenesis of AD, a number of negative studies of anti-inflammatory treatments in the early 2000s dampened enthusiasm.
"The field languished for at least a decade, until three years ago when intriguing findings about genetic risks for Alzheimer's disease clustering around the innate immune system began to emerge, pointing to defects driving pathology," said Margolin. Now, he said, "the study of neuroinflammation in AD is expanding by leaps and bounds." A detailed understanding of the innate immune system and its role in the disease is still evolving, but we now know that the phenotypes of the two key cells comprising the system - astrocytes and microglia - change in the course of the disease. This is dramatic for microglia, which are both factories for producing the chemical component of inflammation - cytokines - and machines designed to engulf injured or dead cells, debris and toxins through phagocytosis. In health, microglia are neuroprotective, demonstrating a robust phagocytic capacity. As AD progresses, however, they begin to spew large amounts of tissue-destructive cytokines and lose their ability to phagocytose dangerous substances such as amyloid fibrils.
Researchers in both academia and industry are investigating the reasons why the earlier trials failed. For example, were the molecular targets wrong, were the trial designs inappropriate, or were the drugs given too early or too late in the disease process?"
Article at:
http://www.medicalnewstoday.com/releases/302308.php?tw
Maybe lead to 'fast track' if results are promising?
Excerpt From Wikipedia:
"The FDA Fast Track Designation is a designation of the United States Food and Drug Administration (FDA) that facilitates the development, and expedites the review, of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days."
Article at:
https://en.wikipedia.org/wiki/FDA_Fast_Track_Development_Program
Alzheimer’s Disease: What’s New?
PART ONE OF DOC GUMSHOE'S UPDATED LOOK AT ALZHEIMER'S DISEASE
Posted on November 4, 2015 by MIchael Jorrin, "Doc Gumshoe"
Article at:
http://www.stockgumshoe.com/2015/11/alzheimers-disease-whats-new/?utm_source=11415&utm_campaign=Daily+Update&utm_medium=email
My comments:
If you are interested in AD, this is a good read. Fairly easy to understand update on where we are at on AD. More to come.
Cheap asthma drug could help fight dementia, GILES SHELDRICK
Oct 28, 2015
Excerpts:
"A CHEAP drug used to treat asthma could reverse the devastating effects of ageing, a study suggests."
"Tests show just a six-week course of commonly available tablets leads to a marked improvement in mental function.
Montelukast appears to work by reducing inflammation in a part of the brain associated with learning and memory"
"Growing old is also associated with a slowdown in the growth of new brain cells and an chronic increase in toxic inflammation.
Neurologist Ludwig Aigner tested montelukast because it blocks inflammation in asthma and could do the same in the brain."
"Dr Laura Phipps, of Alzheimer’s Research UK, said: “We now know that inflammation could play a harmful role in many brain diseases, including those that cause dementia.
“Researchers are investigating a wide range of anti-inflammatory approaches in the search for new treatments for Alzheimer’s and this study in rats uses an existing anti-asthma drug to dampen brain inflammation.”
Doug Brown, of Alzheimer’s Society, said: “We know that inflammation in the brain may contribute to the development of Alzheimer’s disease, and so finding ways to treat this is a potential avenue for researchers. "
Article at:
http://www.express.co.uk/life-style/health/615414/Asthma-pill-fights-dementia
FDA Approves Enstilar Foam in 'Drugs.com', Ballerup, Denmark 19 October, 2015
Excerpts:
"Enstilar was developed to treat patients with psoriasis vulgaris2,3 – the most common clinical form of psoriasis.4
The U.S. approval of Enstilar was based on the Phase 3a PSO-FAST study which evaluated the efficacy and safety profile across a four week period,5 and the Phase 2 MUSE safety profile study.6 In the pivotal Phase 3 PSO-FAST clinical trial, over half of patients treated with Enstilar were “Clear” or “Almost Clear” by Week 4 as measured by the 2-step Investigator GlobalAssessment (IGA) improvement score.1 Additionally, more than half of patients treated with Enstilar achieved a 75% improvement in Psoriasis Area and Severity Index (PASI) score from baseline.7
In March 2015, LEO Pharma submitted Marketing Authorisation Applications to 30 European Health Authorities for Enstilar; however, the product is currently only approved for use in the U.S.
About Enstilar
Enstilar combines a vitamin D analogue (calcipotriene) with a potent corticosteroid (betamethasone dipropionate) to achieve a normalizing result on the affected skin cells and promote a greater anti-inflammatory response than the monotherapy components alone in patients suffering from psoriasis vulgaris."
Article at:
http://www.drugs.com/newdrugs/leo-pharma-announces-u-s-approval-enstilar-foam-calcipotriene-betamethasone-dipropionate-plaque-4279.html?utm_source=ddc&utm_medium=email&utm_campaign=LEO+Pharma+Announces+U.S.+Approval+of+Enstilar+Foam+%28calcipotriene%2Fbetamethasone+dipropionate%29+for+Plaque+Psoriasis
Maxim Group Intiated Rock Creek Pharma (UNKNOWN:RCPI) Stock Coverage With a Buy Rating and TP of $4.00, Oct 20, 2015
Excerpts:
"Maxim Group has initiated its coverage on Rock Creek Pharma (UNKNOWN:RCPI), today 20 October. The financial firm finds the stock of RCPI attractive and has target price of $4.00 with Buy rating.
The initiation is well received by equity trades, as UNKNOWN:RCPI is at the moment trading 8.04% higher at $0.90 as of 08:42 New York time. Rock Creek Pharma’s stock is down -81.56% over the last 200 days. It has underperformed the S&P 500 Index, which has declined -1.19% over the same time period."
Article at:
http://www.octafinance.com/maxim-group-intiated-rock-creek-pharma-unknownrcpi-stock-coverage-with-a-buy-rating-and-tp-of-4-00/230942/
Fungus found in brains raises Alzheimer's questions in "Japan Today', OCT. 17, 2015
My comments: maybe researchers have been chasing the wrong cause?
Excerpts:
"PARIS —
Traces of fungus have been discovered in the brains of Alzheimer’s sufferers, researchers said, relaunching the question: might the disease be caused by an infectious microbe?
There is no conclusive evidence, but if the answer turns out to be “yes”, it means Alzheimer’s Disease (AD) may be targeted with antifungal treatment, a Spanish team reported in the journal Scientific Reports.
“The possibility that AD is a fungal disease, or that fungal infection is a risk factor for the disease, opens new perspectives for effective therapy for these patients,” they wrote.
The five-member team had found cells and other material from “several fungal species” in the brain tissue and blood vessels of all 11 deceased Alzheimer’s patients analysed, but not in ten Alzheimer’s-free controls."
"The main suspect in AD to date has been brain “plaques” caused by a build-up of sticky proteins, but trials with drugs targeting these have yielded disappointing results.
The new study adds another possible cause to the list of hypotheses.
Traces of several fungal species were found, said the team, which “might explain the diversity observed in the evolution and severity of clinical symptoms in each AD patient.”
A fungal cause would fit well with the characteristics of AD, the researchers added, including the slow progression of the disease and inflammation, which is an immune response to infectious agents such as fungi.
The researchers did point out, however, that fungal infection may be the result, not the cause, of AD.
Alzheimer’s sufferers may have a weaker immune response, or changes in diet or hygiene, that could leave them more exposed.
“It is evident that clinical trials will be necessary to establish a causal effect of fungal infection of AD,” wrote the team."
Article at:
http://www.japantoday.com/category/health/view/fungus-found-in-brains-raises-alzheimers-questions
Corbus Pharmaceuticals Announces First Patient Dosed in Phase 2 Study of Resunab(TM) for Treatment of Cystic Fibrosis in 'Market Watch', Oct 15, 2015
Excerpts:
"Corbus Pharmaceuticals Holdings, Inc. CRBP, -3.30% ("Corbus" or the "Company"), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that the first subject was dosed in the Phase 2 clinical study of its investigational new drug Resunab(TM) for the treatment of cystic fibrosis ("CF").
"Patient dosing has commenced as planned in our CF trial and we are on track to report top-line Resunab safety and efficacy data in the CF patient population at the end of 2016," commented Barbara White, M.D., Chief Medical Officer of the Company. "Resunab's novel mechanism of action is not dependent on an individual's underlying CFTR gene mutation. As such, we believe Resunab has the potential for promising clinical benefits to all people with CF."
Resunab is a novel oral drug targeting the resolution of chronic inflammation and debilitating fibrosis associated with disease progression in CF across all CFTR gene mutations. In a pre-clinical CF animal model, Resunab ameliorated inflammation, weight loss, reduced bacterial infection and improved survival."
Article at:
http://www.marketwatch.com/story/corbus-pharmaceuticals-announces-first-patient-dosed-in-phase-2-study-of-resunabtm-for-treatment-of-cystic-fibrosis-2015-10-15
Molecular Switch to Stop Inflammation Identified
Indians Abroad | Press Trust of India in 'NDTV', Updated: October 16, 2015
Interesting article on how 'chronic inflammation' is switched on and off.
Article at:
http://www.ndtv.com/indians-abroad/molecular-switch-to-stop-inflammation-identified-1232838
PRESS RELEASE
Rock Creek Pharmaceuticals Announces Successful Completion of Phase I Clinical Trial to Evaluate Oral Formulations of its Lead Compound, Plans to Conduct Proof-of-Concept Trial in Subjects with Mild to Moderate Psoriasis in 'Market Watch'
Published: Oct 15, 2015 9:43 a.m. ET
Release:
"SARASOTA, Fla., Oct. 15, 2015 /PRNewswire/ -- Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a clinical stage drug development company focused on the application of its lead compound being developed to treat chronic inflammatory conditions, announced today the successful completion of its three part Phase I clinical trial conducted in the United Kingdom (UK). The overall objective of the Phase I trial was to evaluate safety, tolerability and pharmacokinetic (PK) profiles of different formulations of the Company's lead compound, Anatabine Citrate, in healthy volunteers.
In part one of the Phase I trial, subjects took six different oral formulations of the Company's experimental medication while safety and tolerability were assessed. The formulations differed in dose and time release profile, which produced a range of PK outcomes. All formulations were generally well tolerated with no serious adverse events or safety issues leading to study withdrawal. Part two of the trial examined the effects of food on PK profiles produced by single oral doses of the medication. There were no safety concerns with these "food effect" studies and the medication was again well tolerated. Part three of the Phase I trial was a randomized, double blind, placebo-controlled study design consisting of seven days of oral dosing of the study medication (or placebo) which demonstrated that the Company's compound was safe and well tolerated.
All active treatment parts of the Phase I trial were conducted with the healthy volunteers as inpatients in a clinical trial unit. Although the Company expects to have a formal analysis at a later time, the conclusions from the clinical research organization conducting the studies were that there were no clinically significant changes in any safety assessments including clinical lab tests, vital signs and ECGs in any of the parts of the Phase I trial.
With the completion of this Phase I oral dosing trial, the Company is now poised to conduct a proof-of-concept clinical trial to investigate the safety and efficacy of topical formulations of its lead compound in patients suffering from mild-to-moderate psoriasis. Psoriasis is characterized by an increase in activity of the intracellular transcription factors NF-kB and STAT3, which are responsible for driving the inflammation associated with this disease. Much preclinical data suggests that the Company's lead compound can attenuate the activity of these two transcription factors thus producing anti-inflammatory effects. The Company currently anticipates that a safety and efficacy clinical trial for mild-to-moderate psoriasis will commence in the first half of 2016.
"The Company's lead compound performed very well in the Phase I clinical trial, with regard to safety, tolerability, and the consistency of the PK profiles. Although the collected data will be analyzed more thoroughly in the following weeks and months, the preliminary feedback from the clinical research organization conducting the trial and the Company's medical monitor in the UK suggest there are no safety impediments to continued human clinical trials," Noted Dr Ryan Lanier, Chief Scientific Officer of the Company.
Dr Michael Mullan, the Company's CEO commented "This is an important clinical milestone for the Company signifying, as it does, the first regulatory test of its lead compound in human subjects. We can now look forward to testing the safety and efficacy of this compound in human subjects suffering from psoriasis, a chronic inflammatory condition. We are specifically focused on mild-to-moderate psoriasis, which represents an unmet clinical need and will offer us the opportunity to demonstrate proof of concept of this molecule's novel anti-inflammatory properties."
About Anatabine Citrate:Rock Creek Pharmaceuticals' compound is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company has sponsored extensive pre-clinical (in vitro and in vivo) studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer's Disease, and Auto-Immune Thyroiditis. All these studies demonstrated the anti-inflammatory effects of the Company's compound. In addition, the Company's compilation of human exposure, safety and tolerability data, has provided important insights for ongoing clinical and regulatory pharmaceutical development.
About Rock Creek Pharmaceuticals, Inc.:Rock Creek Pharmaceuticals, Inc. is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic and acute inflammatory diseases.
For more information, visit: http://www.rockcreekpharmaceuticals.com
Forward Looking Statements:Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, failure to obtain sufficient capital resources to fund our development program and operations, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our significant payables, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices, pending litigation matters, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2014 filed on March 12, 2015. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time."
CONTACT:
Ted Jenkins
Vice President, Corporate Strategy & Development
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL 34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com
Alzheimer’s Disease: Phase III breakthrough Tau-therapy earns Scottish Biotech €120M in 'LabBioTech.EU, 9/10/2015
Excerpts:
"TauRX is a spin-off biotech from the University of Aberdeen in Scotland (UK) where its clinical trials are being conducted, although its official headquarters are based in Singapore (for tax reasons, perhaps?!). Their Alzheimer’s pipeline has led to the latest generation of their Tau-aggregation inhibitors (TAIs) attracting a massive €120M funding round for its phase III trials.
This figure is staggeringly huge for a clinical trials fundraiser, leading us to question – is this drug really the potential cure for Alzheimer’s the world is waiting for? Or is this simply another example of the biotech spending spree in Neuro-degenerative disease…
Professor Claude Wischik originally identified Tau-protein tangles as responsible for damage in Alzheimer's (Source: Aberdeen Uni)
Professor Claude Wischik originally identified Tau-protein tangles as responsible for damage in Alzheimer’s (Source: Aberdeen Uni)
Tau-protein was identified as a major causative agent in neurofibrillatory ‘tangles’ by Claude Wischik in 1988, who’s research lab at Cambridge (UK) later moved to the University of Aberdeen and founded TauRX. Wischik’s tenure (from 30 years of research experience in Alzheimer’s) could therefore be one of the reasons there is such a strong backing to TauRX’s finances.
However, it is also the fact that TauRX’s phase II results for ‘Rembr’ (their first version of a small molecule Tau-aggregation inhibitor) in 2008 showed a dramatic 81% reduction in disease progression for Alzheimer’s over a 2-year period – a staggering statistic. The latest generation of TauRX TAI (also a methylthioninium compound) is now preparing for phase III and has a much higher bioavailability to their previous candidate, and therefore could be a real breakthrough in the treatment of this neuro-degenerative disease. Perhaps then this €120M really does signify a change in the tide of Alzheimer’s research."
Article at:
http://labiotech.eu/alzheimers-tau-inhibitor-aberdeen-taurx/
Study links psoriasis with blood vessel inflammation in 'Medical News Today', 9 October 2015
Excerpts:
"A new study suggests severity of the skin condition psoriasis is associated with increased inflammation of the blood vessels, or vasculitis.
[Psoriasis]
Researchers have associated greater severity of psoriasis with increased inflammation of the blood vessels.
Senior author Dr. Nehal N. Mehta, a Lasker clinical investigator at the National Heart, Lung, and Blood Institute of the National Institutes of Health, and colleagues publish their findings in the journal Arteriosclerosis, Thrombosis and Vascular Biology.
Psoriasis is a chronic autoimmune skin disease estimated to affect around 7.5 million people in the US. The condition is characterized by red, flakey patches on the skin, most commonly on the elbows, knees, scalp, face, lower back, palms and soles of feet.
Past studies have suggested that people with psoriasis are at greater risk for heart attack and other cardiovascular events, as well as increased risk of cardiovascular-related death.
For their study, Dr. Mehta and colleagues set out to investigate whether psoriasis may be associated with vasculitis - a condition in which the immune system mistakingly attacks the blood vessels, causing them to inflame.
Inflammation of the blood vessels may lead to complications such as aneurism and blood clots, which can obstruct blood flow to the heart and raise risk for heart attack and stroke."
"Compared with participants who were free of psoriasis, those with the most severe form of the skin condition experienced a 51% rise in blood vessel inflammation, and this association was still relevant even after accounting for other factors related to cardiovascular disease.
Overall, the team found that the more severe a participant's psoriasis, the more inflammation there was of their blood vessels. "In other words, what we see on the outside is mirrored on the inside," says Dr. Mehta.
The researchers say their findings support the theory that psoriasis and vasculitis share an underlying mechanism related to the immune system."
Article at:
http://www.medicalnewstoday.com/articles/300534.php?tw
FYI @ 'achooallergy.com':
Excerpts:
"WHAT IS INFLAMMATION?
Inflammation is the activation of the immune system in response to infection, irritation, or injury. Characterized by an influx of white blood cells, redness, heat, swelling, pain, and dysfunction of the organs involved, inflammation has different names when it appears in different parts of the body. Most allergy and asthma sufferers are familiar with rhinitis (inflammation of the nose), sinusitis (inflammation of the sinuses), and asthma (inflammation of the airways), but inflammation is also behind arthritis (inflammation of the joints), dermatitis (inflammation of the skin), and so on.
In the case of allergies, the immune system responds to the presence of an allergen, a normally harmless substance to which it has become overly sensitive. Allergens bind to antibodies, which trigger the release of chemicals like histamine that result in allergy symptoms. In the case of asthma, inflammation causes the airways to swell, making breathing difficult.
As the initial response that fires up the immune system, inflammation is the crucial first step in fighting off infection and healing wounds. However, when inflammation persists - when the immune system is always activated - this is known as chronic inflammation and can lead to chronic disease."
Article at:
http://www.achooallergy.com/learning/chronic-inflammation-chronic-disease/
Old drug offers new hope to treat Alzheimer's disease in 'Medical News Today', 22 September 2015
Excerpts:
"Scientists from the Gladstone Institutes have discovered that salsalate, a drug used to treat rheumatoid arthritis, effectively reversed tau-related dysfunction in an animal model of frontotemporal dementia (FTD). Salsalate prevented the accumulation of tau in the brain and protected against cognitive impairments resembling impairments seen in Alzheimer's disease and FTD.
Salsalate inhibits tau acetylation, a chemical process that can change the function and properties of a protein. Published in Nature Medicine, the researchers revealed that acetylated tau is a particularly toxic form of the protein, driving neurodegeneration and cognitive deficits. Salsalate successfully reversed these effects in a mouse model of FTD, lowering tau levels in the brain, rescuing memory impairments, and protecting against atrophy of the hippocampus--a brain region essential for memory formation that is impacted by dementia.
"We identified for the first time a pharmacological approach that reverses all aspects of tau toxicity," says co-senior author Li Gan, PhD, an associate investigator at the Gladstone Institutes. "Remarkably, the profound protective effects of salsalate were achieved even though it was administered after disease onset, indicating that it may be an effective treatment option."
Although tau has been a target in dementia research for some time, there are no tau-targeted drugs available for patients. Additionally, how the protein builds up in the brain, causing toxicity and contributing to disease, still remains largely a mystery."
Article at:
http://www.medicalnewstoday.com/releases/299880.php?tw
Salsalate from Wikipedia:
"Salsalate is a medication that belongs to the salicylate and non-steroidal anti-inflammatory drug (NSAID) classes. Relative to other NSAIDs, salsalate has a weak inhibitory effect on the cyclooxygenase enzyme and decreases the production of several pro inflammatory chemical signals such as interleukin-6, TNF-alpha, and C-reactive protein.[1] Common conditions in which salsalate may be indicated include inflammatory disorders such as rheumatoid arthritis or noninflammatory disorders such as osteoarthritis. Salsalate is the generic name of a prescription drug marketed under the brandnames Mono-Gesic, Salflex, Disalcid, and Salsitab."
"Salsalate is used to reduce pain and inflammation caused by conditions such as rheumatoid arthritis, osteoarthritis, and related rheumatic conditions. Salsalate is also recommended by physicians as an anti-inflammatory alternative to naproxen, and ibuprofen for patients that have had minor stomach bleeding or stomach upset."
Wikipedia article at:
https://en.wikipedia.org/wiki/Salsalate
Do million-dollar medicines deliver enough bang for the buck?
By Carina Storrs, September 10, 2015
Excerpts:
"If you think prescription drugs have become way too pricey, you are not alone. About three quarters of Americans think that the cost of medications is unreasonable, according to a survey by the Kaiser Family Foundation, a nonprofit health organization."
"Promising new therapies have come out for multiple sclerosis, and they carry price tags that match.
A recent analysis found that the cost of new oral MS drugs such as Aubagio has risen between 8% and 12% each year since they were approved by the FDA several years ago. And these new drugs may have paradoxically driven up the cost of older MS drugs, from about $8,000 to $11,000 in 1993 to $60,000 a year in 2015.
A study of so-called biologic drugs for another autoimmune disease, rheumatoid arthritis, found that they cost between about $10,000 and $20,000 a year, and that patients incur about a third of that cost out of pocket.
A number of biologic drugs for rheumatoid arthritis as well as psoriasis are in the pipeline, and they are probably going to have even higher costs, Pearson said.
Although pharmaceutical companies may defend the price because biologics are more expensive to make than traditional, chemistry-based drugs, they face less competition from generic versions and can make up some of the cost that way, he said."
Article at:
http://www.cnn.com/2015/09/10/health/expensive-medications-value/index.html
96% Of NFL Players In Study Test Positive For Brain Disease in "Forbes Pharma and Healtcare', SEP 18, 2015
Excerpts:
"Researchers announced on Friday that 87 of 91 former NFL players have tested positive for chronic traumatic encephalopathy, or CTE. The disease has been linked to repetitive head trauma and is believed to cause mood swings, memory loss and dementia. Currently, researchers are only able to accurately diagnose CTE by doing an autopsy.
It’s worth noting that the study doesn’t draw on a representative sample of all NFL players. Instead, the researchers studied the brains of players that were donated to their center; disproportionately, these athletes displayed tendencies in life that suggested they were suffering from brain disease.
But this isn’t just an NFL problem, either: The researchers have now found CTE in nearly 80% of all brains donated to their brain bank, PBS Frontline reports. (That includes high school, college and semi-pro football players, too.)"
Article at:
http://www.forbes.com/sites/dandiamond/2015/09/18/96-of-surveyed-nfl-players-test-positive-for-brain-disease/?ss=pharma-healthcare
Posting by Izof_Texas on CIGX_VIPGROUP:
"I don't know how many have seen the full text of the rosacea study of the facial cream. I just ran across it and cite it here in case someone is interested. Small study. It worked well (70% reported improvement), though not as dramatically as it did for me (and some others who have reported). If some day they can get this on the market for $49 instead of $199 they'd really have something. I hope I have a face left by then : )"
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3861860/
Type I IFNs Incapable of Inducing Remission in Ulcerative Colitis in 'IBD News Today', SEPTEMBER 17TH, 2015
Excerpts:
"In a recent review study entitled “Type I interferons for induction of remission in ulcerative colitis”, the authors revised clinical studies and concluded that type I interferon therapy, successfully used in several chronic inflammatory diseases, does not induce ulcerative colitis remission in patients with active disease. The study was published in the Cochrane Database of Systematic Reviews.
Ulcerative colitis (UC) is one of the main types of inflammatory bowel disease (IBD), together with Crohn’s disease, and is characterized by chronic inflammation particularly of the colon and small intestine."
Article at:
http://ibdnewstoday.com/2015/09/17/type-ifns-incapable-inducing-remission-ulcerative-colitis/
Interesting comments in the Daily Mail:
Can going to the dentist give you Alzheimer’s? The lethal brain disease could be transmitted by contaminated instruments
Research says that damaging proteins could be transferred via instruments
Protein builds up into small clumps, blocking signals between brain cells
This doesn't mean that you shouldn't go to the dentist
Should also be aware of gum disease, which can increase Alzheimer's risk
By JOHN NAISH FOR THE DAILY MAIL
PUBLISHED: 19:49 EST, 14 September 2015
Excerpts:
"Professor Perry's team recently ran a pioneering trial on 40 people to see if etanercept, a drug that dampens inflammation and is already prescribed for rheumatoid arthritis, helps slow down the progress of Alzheimer's.
For a six-month study published in Neurology in May, etanercept was given to 20 people with mild Alzheimer's, who were compared to similar patients who took a placebo.
'What we clearly saw is that the arrow is pointing in the right direction,' said Professor Perry. 'The people on the placebo drug continued to decline, but the progression of the disease was delayed in those on etanercept. We are now doing further studies on this.'"
Read more: http://www.dailymail.co.uk/health/article-3234585/Can-going-dentist-Alzheimer-s-lethal-brain-disease-transmitted-contaminated-instruments.html#ixzz3lqriugVH
Follow us: @MailOnline on Twitter | DailyMail on Facebook
Catabasis Pharmaceuticals Receives Rare Pediatric Disease Designation from FDA for CAT-1004 for the Potential Treatment of Duchenne Muscular Dystrophy in 'Business Wire', September 14, 2015
My comments: Wonder if Mullan is mulling 'fast track'?
Excerpts:
"CAT-1004 is an oral small molecule that inhibits activated NF-kB, a protein that coordinates cellular response to muscular damage, stress and inflammation and plays an important role in muscle health. In skeletal muscle, activated NF-kB drives muscle degeneration and suppresses muscle regeneration. In animal models of DMD, CAT-1004 inhibited activated NF-kB, reduced muscle inflammation and degeneration and increased muscle regeneration. In Phase 1 clinical trials, CAT-1004 inhibited activated NF-kB and was well-tolerated with no observed safety concerns. The FDA has granted CAT-1004 orphan drug and fast track designations for the treatment of DMD. Catabasis is currently conducting the MoveDMD Phase 1 / 2 trial of CAT-1004 in 4-7 year-old boys with DMD."
Article at:
http://www.businesswire.com/news/home/20150914005314/en/Catabasis-Pharmaceuticals-Receives-Rare-Pediatric-Disease-Designation#.VfdKgNJVhHw
Archer does have an 'investor relations' contact person listed on their website so looks like they are open to a private placement. (or maybe a public placement when results are in?)
Jerry Smith (941) 755-6644.
http://www.archerpharma.com/investor_relations.html
In the past, Mullan has said that the potential drug for Alzheimers may require a cocktail (more than one drug) for efficacy. Is this why he volunteered to run Rock Creek? This is kinda like Baccarat, one hopes to win but in Baccarat, one card can be a 'nine' and the other a zero (to win) or any combination to make nine out of the first two cards or draw of additional cards (Player---we investors). Over nine and you probably have a losing hand. The FDA already has a 'nine' delt to themselves. (Banker) Or like Black jack, Mullan has double downed on Archer with the blind draw card Rock Creek. Having said that, Rock Creek has more potential avenues in addition to Alzheimers so the possibilities are greater. Since 'safety' appears one of Anatabine Citrates winning suits, finding it's greatest reward (read monetization) without going broke is the bet. Place your bet gamblers (investors?)
Mullan's other company is Archer Pharmaceuticals and it's focus is on Alzheimers. Their current drug undergoing clinical trials in Europe is Nilvadipine. I think Archer was started to monetized the Alzheimers research Mullan etal was doing at the non-profit Roskamp. If you go to the Archer website, lo and behold the Roskamp team are officers at Archer, ie Crawford etal. (Crawford is the CTO at Archer and she is the CEO at Roskamp. So, it would appear that Alzheimer monetization is at Archer, inflammatory diseases monetization is at Rock Creek. Roskamp is the Alzheimer/inflammation research department. Any other guesses?
The Archer website is at:
http://www.archerpharma.com/default.html
In looking at past 'buy ins/buy outs' by Big Pharma in small Pharmas, most have occurred somewhere around phase 2 to phase 3 of their clinical trials. Seems like they want as much of a 'sure thing' as they can get before they pony up some dough, even though the cost is higher, they seem to not have a problem with that. On some rare occasions, maybe where the data indicates, they come in earlier and collaborate with funds and support to speed up the process. I assume this happens when the potential product has great expectations.
Five Surprising Diseases That threaten Your Heart in 'Link', September 5th, 2015
Excerpts:
"Damage from psoriasis red, itchy, scaly skin condition runs more than skin deep, with studies linking it with heart disease, stroke and other blood vessel diseases. A massive analysis of 75 studies involving 503,686 cases and 29,686,694 controls found that people with psoriasis are more prone to develop heart failure, with the risk rising as the psoriasis gets more severe. Chronic inflammation — a component of both heart failure and psoriasis — may be the link between the two, reported the 2013 study from Denmark in the Journal of American Academy of Dermatology.
Psoriasis affects 125 million people worldwide. The Danish study recommends early screening and treatment of heart risk factors in patients with psoriasis."
Article at:
http://thelinkpaper.ca/?p=49029
Psoriasis information website---Look at current treatments and their adverse effects. There appears to be a new page being developed to track psoraisis new drug pipeline (nothing now). Let's hope they recognize Anatabine Citrate. See:
https://www.psoriasis.org/
Fat deposits in brain may hasten Alzheimer's disease in 'Medical News Today,', 28 August 2015
Excerpts:
"reakthrough in Alzheimer's research reveals that an abnormal build-up of fat droplets in the brain may cause or speed up the disease. The finding promises to open new avenues in the search for a cure or new treatments.
woman with dementia with carer
The study could prove to be a missing link in the field of Alzheimer's disease research.
The research, led by the Research Center of the University of Montreal Hospital (CRCHUM) in Canada, is published in the journal Cell Stem Cell.
The researchers note how, for the first time since 1906, when Dr. Alois Alzheimer first described the disease that takes his name, they found accumulations of fat droplets in the brains of patients who died of the disease. They have also identified the type of fat."
"The team believes the finding could prove to be a missing link in the field of Alzheimer's research.
Senior author Karl Fernandes, a CRCHUM researcher and professor at the University of Montreal, explains:
"We discovered that these fatty acids are produced by the brain, that they build up slowly with normal aging, but that the process is accelerated significantly in the presence of genes that predispose to Alzheimer's disease."
The researchers found that the brains of mice predisposed to the disease build up these fatty acid deposits at 2 months, which in human terms would be the early twenties.
"Therefore, we think that the build-up of fatty acids is not a consequence but rather a cause or accelerator of the disease," Prof. Fernandes says.
The team says inhibitor drugs that are already being tested for metabolic diseases such as obesity, can block the enzyme that produces these fatty acids and stop them accumulating. Tests on mice predisposed to the disease confirmed this. Prof. Fernandes concludes:"
Article at:
http://www.medicalnewstoday.com/articles/298729.php?tw
Discovery Reveals How Inflammation In The Body Occurs, Gives Clues For New Drugs in 'Forbes', Emily Mullin, AUG 27, 2015
Excerpts:
"What do seemingly unrelated medical conditions like Alzheimer’s, cancer, diabetes and heart disease have in common? Answer: They’ve all been connected to excess inflammation in the body.
Because of its link to many age-related diseases, there’s growing interest among pharmaceutical and biotech companies to find new targets involved in inflammation that could lead to novel anti-inflammatory drugs. But while the symptoms of inflammation in disease are well known, scientists still do not fully understand the biological mechanisms behind it.
Now, researchers at Virginia Tech and their collaborators have identified key cellular functions that help regulate inflammation – a discovery that could have important implications for drug development. The findings, published in the journal Structure, explain how two proteins in particular, called Tollip and Tom1, work together to trigger inflammation."
"Capelluto said molecules designed to mimic how Tollip and Tom1 act in the body but are more efficient at clearing receptors could have strong anti-inflammatory properties."
Article at:
http://www.forbes.com/sites/emilymullin/2015/08/27/discovery-reveals-how-inflammation-in-the-body-occurs-gives-clues-for-new-drugs/
New study provides links between inflammation and colon cancer metastasis in 'Medical News Today', 25 August 2015
Excerpts:
"A new Arizona State University research study led by Biodesign Institute executive director Raymond DuBois, M.D., Ph.D., has identified for the first time the details of how inflammation triggers colon cancer cells to spread to other organs, or metastasize.
The findings will enable researchers to identify new drug targets for the prevention and treatment of colon cancer. DuBois, a leader in colorectal cancer research for more than two decades, has been exploring the risk factors between chronic inflammation and cancer, including colorectal cancer.
"We've long known that simple things like taking aspirin or other anti-inflammatory drugs (called nonsteroidal anti-inflammatory drugs, or NSAIDs), have beneficial effects on reducing the risk of colorectal cancer," said DuBois. "But non-aspirin NSAIDs can cause serious cardiovascular side effects when taken over a long period of time, so we've needed to discover better drug targets. This study points us in the right direction."
The findings could mean new hope for more effective colorectal cancer treatments and screening methods. Currently, nearly half of patients with advanced colorectal cancer die within five years following treatment. One reason may be that the cancer becomes more chemotherapy resistant, but other evidence has supported the role of inflammation and inflammatory mediators in tumor metastasis.
The research team was able to show how a colon cancer tumor could outwit its host, using an inflammatory mediator to expand its cancer stem cells in order to seek out other organs. They showed a direct link between the pro-inflammatory mediator prostaglandin E2 and increased colorectal cancer stem cells."
Article at:
http://www.medicalnewstoday.com/releases/298587.php?tw
Rodman & Renshaw 2015 Annual Global Investment Conference to be held in New York from September 8 to 10, 2015 in 'PR Newswire'
Excerpts:
" More than 200 public & private companies from around the world are expected to present to an audience of over 2,000 attendees. The event will feature tracks devoted to Biotechnology/Healthcare, Metals & Mining, Technology, Cleantech and Growth. The Conference will include corporate presentations and Q&A sessions, investor one-on-one meetings and daily networking opportunities. Institutional investors, venture capitalists, private equity firms, sophisticated private investors and industry executives are welcome to attend this conference. "
My comments: partial list of presenting companies in release.
News release at:
http://www.prnewswire.com/news-releases/rodman--renshaw-2015-annual-global-investment-conference-to-be-held-in-new-york-from-september-8-to-10-2015-300110562.html
“THE WORLD DERMATOLOGICAL DRUGS MARKET WILL REACH $24.1BN IN 2014 PREDICTS NEW VISIONGAIN REPORT” in 'VisionGain', 2014
Excerpts:
"LONDON, UK, 15TH April 2014: A new report by visiongain predicts that the world market for dermatological drugs will reach $24.1bn in 2014. This forecast and others appear in Dermatological Drugs Market Forecast 2014-2024: Future Prospects for Leading Companies, published in April 2014. Visiongain is a business information provider based in London, UK.
Dermatological drugs are available to treat a range of skin diseases including psoriasis, skin infections, acne and dermatitis/eczema. This specialty area of pharmaceuticals has been growing in recent years due to the availability of blockbuster biological therapies for psoriasis and the launch of new treatments for some infectious skin disorders. Humira, Enbrel and Stelara lead the market in terms of revenue. In other areas mid-size specialist dermatology companies dominate, with Galderma and LEO Pharma ranking in visiongain’s top ten dermatological drugs companies by revenue."
Article at:
https://www.visiongain.com/Press_Release/611/%E2%80%9CThe-world-dermatological-drugs-market-will-reach-24-1BN-in-2014-predicts-new-Visiongain-report%E2%80%9D
I visit China annually and your view is correct. Mainland Chinese top priority is their children and their education/health. Second priority is their health, especially as they get older---and they are demographically getting older. Having said that, read the following comments from a Hawaiian GNC store re Chinese tourists at:
http://www.hawaiibusiness.com/big-draw-for-chinese-tourists-fish-oil-and-other-supplements/
Bottom line:
-Average Chinese tourist spends $300 per viisit.
-Not uncommon for them to spend $1000 just for fish oil.
-Aversion to Chinese manufactured supplements.