SAN DIEGO, June 6, 2016 /PRNewswire/ -- Aethlon Medical, Inc. (AEMD), announced today that Jim Joyce, Chairman and CEO, will be presenting tomorrow (June 7th) at the BIO International Convention being held at Moscone Center in San Francisco, California. The presentation, which is scheduled to begin at 10:45AM (PT), will review Aethlon Medical's initiatives to combat cancer and infectious disease. Mr. Joyce will also present the discovery of a non-invasive candidate biomarker to diagnose CTE that was made in collaboration with Exosome Sciences, a majority-owned subsidiary of Aethlon Medical. CTE is a neurological disorder associated with exposure to repetitive head impacts, such as those experienced by American football players. At present, CTE can only be definitively diagnosed through post-mortem autopsy. The presentation can be accessed on-line through the following link:
Prior to Mr. Joyce's presentation, Will Smith, the critically acclaimed star of the film "Concussion", will headline the Convention with a keynote address and moderated discussion from 9-10:30AM (PT). In "Concussion", Smith portrayed Dr. Bennet Omalu, best known for his role in the discovery of CTE in a professional football player. As part of the keynote presentation, Dr. Omalu will be in attendance with Smith for an interview with Jim Greenwood, BIO's President and Chief Executive Officer. The BIO International Convention is the world's largest gathering of the biotechnology industry.
About Aethlon Medical
On a congressional report that found the NFL improperly tried to influence the research and withdrew funding for the study because it felt Stern is biased:
Stern: “I don’t talk about funding issues. It’s just not the thing to do in science. I’m absolutely thrilled that the NIH decided to fund this project. And I’m just really focused on moving the science forward.”
Fox: “The NFL is scared to death of CTE because it can affect their bottom line. And the reality is the NFL is all about making money. They’ve got 32 owners that want to protect their income source. And this is a dramatic threat to the game itself. It’s a dramatic threat to Pop Warner. It’s a threat to high school football. It’s a threat to college football. And as people stop playing at those levels, they will not have the same level of interest in the NFL. So the NFL has consistently dragged their feet in terms of trying to recognize that they have a problem, and they will only admit they have a problem when they’re backed into a corner or they say something by mistake. And so the example of taking the funding away from a project that they had pledged — where they said there would be no strings attached — and then backtracked and took the money back, is just another example of that.”
We were not able to reach the NFL for a response to Fox’s comment.
In A First, NFL Executive Admits Football Is Linked To Brain Damage
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BOSTON About 50 medical researchers from around the country converged on Boston Wednesday, as they prepare to launch a massive seven-year study into the brain disease known as chronic traumatic encephalopathy, or CTE, in July.
CTE is a degenerative disease similar to Alzheimer’s. It’s only found in people who’ve played football, boxed or taken part in other contact sports.
The researchers are recruiting 180 former NFL and college football players in order to study their brains. The goal is to develop ways to diagnose CTE in people while they’re alive. The only way to diagnose it right now is by studying the brain after death.
One of the lead researchers is Robert Stern, Ph.D. He’s a Boston University School of Medicine professor of neurology and neurosurgery and director of clinical research at BU’s Chronic Traumatic Encephalopathy Center.
Helping Stern champion the research is Tim Fox, a 62-year-old former NFL safety who played for the Patriots, Chargers and Rams. He thinks he has CTE.
Fox and Stern spoke with WBUR’s All Things Considered host Lisa Mullins about the disease. Stern says while much of the focus has been on concussions, CTE is caused by something that can seem more benign.
On diagnosing chronic traumatic encephalopathy:
Stern: “The only people who have ever been diagnosed with it after life, which is the only way to diagnose it, have had a history of repetitive hits to the head. It’s never been seen in someone without that kind of history… It’s a disease that gets set in motion from having repetitive hits … regardless of whether they are symptomatic concussions.”
Fox: “For me, the symptoms are difficulty recalling names, events, issues — even in common speech. I have trouble sometimes grasping what I want to say. It affects your personality. It’s a very frustrating situation when you can’t recall things that you’d like to recall. And I don’t know whether that leads to a much shorter fuse. You know, I don’t have the patien
June 1, 2016 /PRNewswire/ -- Aethlon Medical, Inc.(AEMD) , today announced that Jim Joyce, Chairman and CEO, will be presenting at the 2nd Annual Sachs Associates Immuno-oncology: BD&L and Investment Forum (http://www.sachsforum.com/2nd-immuno-oncology-bdl-and-investment-forum.html) at the Hyatt Chicago Magnificent Mile Hotel in Chicago, IL at 10:20 p.m. Central Time on Friday, June 3, 2016. About Aethlon Medical(AEMD) Aethlon Medical (AEMD) is a leading developer of immunotherapeutic technologies to combat infectious disease and cancer.
To augment the body's natural immune defenses, the Aethlon Hemopurifier® eliminates life-threatening disease targets that are often shielded from the immune system and not well addressed by traditional drug therapies. The technology captures circulating viruses, bacterial toxins and cancer promoting exosomes through affinity attachment to a unique structure that cloaks these targets from immune detection. At present, the Hemopurifier® is being advanced under an FDA approved clinical study. Aethlon is also the majority owner of Exosome Sciences, Inc., a company focused on the discovery of exosomal biomarkers to diagnose and monitor life-threatening diseases.
Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+. The Hemopurifier® in Cancer Upwards of ninety percent of all cancer-related deaths are attributed to metastasis; the spread of cancer from a primary site of origin to other organs or areas of the body. The mechanism of how tumors metastasize to distant sites in the body has long been one of cancer's greatest mysteries? That mystery was recently solved when circulating particles known as tumor-derived exosomes were discovered to be the seeds that promote the spread and growth of cancer metastasis. Aethlon initiated its tumor-derived exosome research at a time when the medical community believed exosomes were merely cellular debris with no biological function.
Today, a therapeutic to address tumor-derived exosomes represents a significant unmet need in cancer care. Aethlon has demonstrated that the affinity mechanism of the Hemopurifier® can capture tumor-derived exosomes underlying several forms of cancer, including breast, ovarian and metastatic melanoma. Beyond their role in metastasis, researchers have also published mounting evidence that tumor-derived exosomes contribute to tumorigenesis (the formation of cancer), cancer progression, angiogenesis (creation of blood vessels to fuel tumor growth), immune evasion, and resistance to radiation and chemotherapeutic drugs. Recent discoveries also reveal that exosomes may contribute to bacterial and viral pathogenesis, the progression of Alzheimer and Parkinson's diseases, the spread of prion proteins, and numerous inflammatory conditions.
The Hemopurifier® in Infectious Disease Emerging pathogens pose a significant threat to mankind. Of the hundreds of viral pathogens known to be infectious to man, only a few are addressed with proven antiviral drug or vaccine therapies. Beyond the looming threat of bioterrorism, a proliferation of international travel, urban crowding and global warming is expected to accelerate the emergence of future pandemics. In response, the U.S. Department of Health and Human Services (HHS) has established an initiative to support platform technology medical countermeasures with broad-spectrum capabilities.
Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier® defines this initiative. To date, Hemopurifier therapy has been administered to individuals infected with Ebola virus, Hepatitis C virus (HCV) and the Human Immunodeficiency virus (HIV). In the case of Ebola, a remarkable response to a single administration of Hemopurifier therapy (comatose physician with multiple organ failure at the time), led to Time Magazine naming the Hemopurifier to be one of the "Top 25 Inventions" as well as one of the "Eleven Most Remarka
U.S. Feasibility Study Progressing
In 2015 Dr. Ronal Ralph was brought on as the new principal investigator. Aethlon (AEMD) since brought on two sub-principal investigators. While progression of the study has been drawn out longer than initially anticipated, in late March AEMD announced that a patient had completed a six-treatment protocol of Hemopurifier therapy. Then in early May the company announced that a second patient completed the treatment protocol and third has been enrolled and commenced treatment. AEMD also noted that they have a cGMP manufacturing system operational which is manufacturing Hemopurifier devices for this study.
As a reminder, this is a safety study being conducted at DaVita Medical Center Dialysis in Houston with target enrollment of 10 HCV-infected patients who are already undergoing dialysis. Patients will receive Hemopurifier treatment three times per week for two weeks. This is primarily a safety study but secondary outcomes including quantity of captured viral copies and change in viral load will also be measured. Results which were initially expected to be used solely for support of FDA approval to conduct larger pivotal studies in HCV as well as potentially other diseases such as HIV and cancer, are now expected to be used to move into clinical studies for other viruses and pandemic threats.
Once this HCV feasibility study is completed, and assuming positive results, this is expected to form the basis to move into U.S.-based studies for potential end-use type indications in areas such as latent viral pathogens and pandemic type diseases. Zika virus has recently become a significant concern, not only in areas where it is traditionally found such as S. America and equatorial regions of Africa and Asia, but now also in parts of the U.S. The World Health Organization just declared the Zika virus outbreak an international public health emergency. Zika is one of the pandemic-type threats that could be on a short-list of targets for Hemopurifier. The device has already been validated in in clinical studies in a number of targets including Ebola, HIV and HCV and in vitro studies in Chikungunya, Dengue virus, multiple strengths of Ebola virus, H1N1 swine flu, H5N1 bird flu virus, the reconstructed Spanish flu of 1918 virus and West Nile virus. Zika could be next and clinical studies in the U.S. in some of these targets or others could be on the horizon in the near-term. And, given the severity of these viruses and lack of effective treatments, it is conceivable Hemopurifier could a fast-track candidate. This is something we expect to hear more about from AEMD in upcoming conference calls.
ESI Broadens Access to ELLSA Platform
Following compelling initial results of the CTE study (detailed below) as well as in identifying HIV via isolation of urinary exosomes and subsequent analysis, AEMD announced that they will begin production of their ELLSA diagnostic platform and look to collaborate with other institutions interested in pursuing diagnostics related to disease-specific exosomes.
CTE Study Published Online in Journal of Alzheimer’s Disease
As a reminder, Aethlon’s majority-owned subsidiary Exosome Sciences (ESI) has collaborated with Boston University’s CTE Center for the development of a blood-based diagnostic that would be able to identify CTE in living individuals. ESI has used what they learned in how to isolate certain brain-specific biomarkers to evaluate blood/plasma samples collected by participants (former NFL players and a control group) enrolled in BU's DETECT study. The study is the first on CTE funded by the NIH.
In April 2015 investigators presented initial findings of DETECT at the annual Traumatic Brain Injury Conference held in Washington, DC. Results were from 78 former NFL players and 16 controls and showed that the NFL players had significantly higher levels of tausome (tau) in their blood/plasma than those of the controls. Tau levels were also correlated to performance on cognition tests, with higher tau levels corresponding to poorer test performance.
Aethlon submitted a manuscript of the study in 2015, which was published in the online version of the Journal of Alzheimer’s Disease earlier this month. Inclusion criteria for the NFL group included age 40-69, a minimum of 12 years of tackle football including a minimum of 2 years in NFL at position associated with extensive head impacts and a self-report of having symptoms associated with CTE including changes in cognition, behavior and mood. Inclusion criteria for control included male age 40-69, minimum of 4 years in non-contact sports including 2 at college level or higher.
The publication provided additional details of the results which included (all charts and graphics[if !supportFootnotes][endif]);
Total plasma exosomes did not differ between the NFL and control groups and NFL did have significantly higher (p
Plasma exosome levels were still statistically significantly higher (p
The diagnostic demonstrated 82% sensitivity with 100% specificity, 100% positive predictive value and 53% negative predictive value. In other words, all of the elevated tau results came from NFL players, although not all NFL players showed elevated tau levels
In the NFL cohort, tau levels were statistically significantly inversely correlated to performance on cognition tests (Wechsler Adult Intelligence Scale Digital Symbol and Neuropsychological Assessment Battery List Learning)
While exosomal tau was statistically correlated to cognition, it was not correlated to any of the mood or behavioral measures
July 23, 2013
Battelle Team Wins DARPA Contract to Build Medical Device to Treat Sepsis
Up to $22.83M in funds to be allocated for the Battelle, NxStage and Aethlon collaboration to develop an advanced portable medical device for DARPA-and ultimately civilian-use.
Columbus, OH., 23, July 2013— At Battelle, supporting America's military personnel is woven into the fabric of its business. In that pursuit, a team consisting of Battelle, NxStage Medical (NXTM), Inc. and Aethlon Medical (AEMD) has won a contract from the Defense Advanced Research Projects Agency, or DARPA, to develop an innovative, new medical device that may save the lives of soldiers—and civilians as well—by treating sepsis.
The problem to be confronted is more severe than is commonly known—as many as 10 percent of combat wounds result in life threatening infections that ultimately lead to septicemia and/or sepsis. "This device could not only save many of our soldier's lives, it could be profoundly important in saving thousands of civilian lives each year in the United States alone," said Martin Toomajian, President of Battelle Energy, Health and Environment.
DARPA created the Dialysis-Like Therapeutics (DLT) program to develop a portable device that creates a holistic treatment for sepsis. The device is intended to remove blood from the body, separate harmful "dirty" agents from the blood and return "cleaned" blood to the body in a manner similar to dialysis treatment for kidney failure. DARPA has made significant investments in its DLT effort to date to multiple contractors for the development of key blood purification and diagnostic technologies that could contribute to the ultimate device.
This contract—which is funded in phases and could be as large as $22.83 million and last as long as four years—is for leading one of DARPA's DLT System Integration projects. The project calls for Battelle and key subcontractors, NxStage and Aethlon, to design, develop, test and validate an advanced, portab
U.S. probes contracts between drugmakers, pharmacy benefit managers
May 10, 2016
(Reuters) - The U.S. Attorney's Office for the Southern District of New York is investigating contracts between drugmakers and companies that manage prescription benefits, according to regulatory filings.
Federal prosecutors have approached at least three companies, including Johnson & Johnson, Merck & Co and Endo International Plc, demanding information about their contracts with pharmacy benefit managers.
Pharmacy benefit managers, or PBMs, which administer drug benefits for employers and health plans and also run large mail-order pharmacies, have been challenging the rising cost of new medications.
When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.
J&J said in a regulatory filing on Tuesday it had received a "civil investigative demand", seeking information about its contractual relationships with pharmacy benefit managers over some of its products from early 2006 through the present.
Merck said on Monday it had received a demand for information about contracts with, services from and payments made to PBMs in relation to its migraine drug, Maxalt, and erectile dysfunction treatment Levitra, over the same period.
Endo said last week it was cooperating with such an investigation, looking into its PBM contracts for its migraine therapy, Frova.
The companies did not disclosed the name of any PBM in their respective filings. Express Scripts Holding Co is the nation's largest pharmacy benefit manager, followed by CVS Health.
J&J, Merck and Endo and CVS were not immediately available for comment. Express Scripts and the U.S. attorney's office for the Southern District of New York declined to comment.
Last November, a U.S. unit of Swiss drugmaker Novartis AG agree
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Market Wire Report.
Aethlon Medical's CEO and Executive Chairman James Joyce Interviewed by The Life Sciences Report MARKET WIRE 9:00 AM ET 5/5/2016 SAN FRANCISCO, CA -- (Marketwired) -- 05/05/16 -- Exosome Sciences, a majority-owned subsidiary of Aethlon Medical Inc.(AEMD) , is developing an exosome-based platform to diagnose a broad-spectrum of disease conditions.
In this interview with The Life Sciences Report, Executive Chairman James "Jim" Joyce shares the initial clinical results of a biomarker study to diagnose chronic traumatic encephalopathy (CTE), a neurodegenerative disorder often found in professional football players through postmortem autopsy. Mr. Joyce reports on the discovery of a TauSome™ biomarker found to be 9x higher, on average, in former National Football League players as compared to control subjects.
Exosome Sciences believes its TauSome test may be the first noninvasive candidate to diagnose CTE in living individuals. The Life Science Report: What triggered Aethlon Medical Inc.(AEMD), through its subsidiary Exosome Sciences, to pursue the discovery of a biomarker that could identify CTE in living individuals? Jim Joyce: While we may be best known for our broad-spectrum therapeutic platform, our CTE-related research was triggered by the death of a former friend and teammate, who was the second person diagnosed with CTE by our colleagues at the Boston University CTE Center.
This factor, and the reality that there was no way to identify CTE in the living, inspired us to take on the challenge of solving this problem. Based on our research history and knowledge of disease-released exosomes, we thought it might be possible to identify an exosomal biomarker that could cross the blood-brain barrier with cargo that could help identify and potentially monitor neurological disease conditions. We translated our belief into the discovery of an exosomal biomarker that we call a TauSome™. In addition to CTE, we believe circulating TauSome levels could emerge as candidates to monitor other neurological disorders, such as...
released the following note authored by its Chairman and CEO, Jim Joyce.
At present, we are conducting the first FDA approved study of Hemopurifier® therapy as a candidate broad-spectrum countermeasure against viral diseases. While a transition of principal investigators contributed to a slow start, the pace of our study is now progressing. On March 31st, we disclosed that our new principal investigator had administered a six-treatment protocol of Hemopurifier therapy to an enrolled patient and had consented the enrollment of a second patient. Since that disclosure, the consented patient has completed our treatment protocol and a third patient has been enrolled and initiated the study protocol, which upon completion will represent a total of four treated patients who met the inclusion criteria. The study calls for a total enrollment of 10 patients.
Upon successful completion, the study will support the advancement of our Hemopurifier as a broad-spectrum treatment countermeasure against bioterror and pandemic threats and will also provide a pathway into pivotal studies of chronic viral diseases that allow for controlled human efficacy studies to be conducted.
Previous preclinical and clinical validations suggest that our first-in-class technology could address significant unmet needs in infectious disease. Especially, when considering the impossibility of aligning a traditional drug or vaccine agent with each and every pathogen threat. Of the hundreds of viruses known to be infectious to man today, fewer than ten are addressed with proven antiviral drug therapies. This is not inclusive of new viral threats that emerge naturally or are released by man as agents of bioterrorism. Beyond the recent Ebola and Zika outbreaks, a proliferation of international travel, urban crowding and global warming will contribute to fuel the emergence of future pandemic threats.
Last week, former U.S. Senate Majority Leader, Tom Daschle and former White House Ebola Response Coordinator, Ron Klain authored an editorial in the USA Today entitled: "We're not ready for the next Zika virus". The editorial further reinforces the need for medical countermeasure to treat bioterror and pandemic threats.
In regards to pandemic threats, the authors stated that in the aftermath of the anthrax attacks of 2001, the Ebola outbreak of 2014 and now Zika, it is no longer a question of if but when the next biosecurity threat will occur. That experts believe a pandemic, not nuclear terrorism or climate change, is most likely to cause 10 million or more deaths in a single event.
In regards to bioterror threats, the authors shared what President Obama's National Security Council noted in 2009, "The effective dissemination of a lethal biological agent within an unprotected population could place at risk the lives of hundreds of thousands of people. The unmitigated consequences of such an event could overwhelm our public health capabilities, potentially causing an untold number of deaths. The economic cost could exceed one trillion dollars for each such incident." The authors point out that numerous commissions and panels have concluded that biological threats have the potential for catastrophic consequences within the United States, and have provided recommendations for a path forward. In conclusion, the authors ask if policy-makers will finally act?
From our perspective, we have observed that policy-makers have indeed been taking steps to protect U.S. citizens. Evidence of such steps can be found in the 2015 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan (SIP), which describes the priorities that the U.S. Department of Health and Human Services (HHS), in collaboration with its interagency partners, will implement over the next five years to protect against bioterror and emergency pandemic threats. A primary objective of the PHEMCE SIP includes the advancement of platform technology medical countermeasures with broad-spectrum capabilities. Based on preclinical studies and human treatment experiences, the Aethlon Hemopurifier defines this objective.
To date, Hemopurifier therapy has been successfully administered to individuals infected with Ebola, Hepatitis C and the Human Immunodeficiency virus (HIV). In the case of Ebola, a remarkable response to a single 6.5-hour administration of Hemopurifier therapy (comatose physician with multiple organ failure at the time) was presented at the American Society of Nephrology Annual Meeting and subsequently published in a peer-reviewed scientific journal. The physician made a full recovery and returned home to his wife and children.
Beyond human treatment experiences, pre-clinical Hemopurifier studies (reported to date) have validated the capture of many high-priority viral threats. These include: Chikungunya, Dengue and West Nile virus, as well as Vaccinia and Monkey pox, which serve as models for human smallpox infection. Specific to pandemic influenza threats, we have validated the capture of H5N1 avian flu, H1N1 swine flu, and the reconstructed 1918 influenza virus, which represents a model for the strain of influenza that killed an estimated 20 million to 50 million victims in 1918 and 1919. In vitro studies of other viral threats are ongoing.
While these clinical experiences may help to reinforce the validity of our broad-spectrum therapeutic vision, we also understand that continued clinical progression is necessary to unlock the true value of our endeavors.
Chairman and CEO
About Aethlon Medical, Inc.
Aethlon Medical AEMD, +14.40% creates affinity biofiltration devices to treat life-threatening diseases. The Aethlon Hemopurifier® is a leading broad-spectrum treatment countermeasure against infectious viral pathogens. The device, which has been successfully administered to individuals infected with HIV, Hepatitis C (HCV) and Ebola virus, is currently the subject of FDA approved clinical studies. Aethlon is also studying the potential use of the Hemopurifier® to address exosomes secreted by tumors to promote the spread of metastasis and suppress the immune system of cancer patients. The Company provides government contracting services to the Defense Advanced Research Projects Agency (DARPA) related to the development of a biofiltration device to treat sepsis and maintains majority ownership of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor Chronic Traumatic Encephalopathy (CTE) and other neurological disorders. Additional information can be found online at www.AethlonMedical.com or you can connect with us on Twitter, LinkedIn, Facebook and Google+.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. Factors that may contribute to such differences include, without limitation, the Company's ability to maintain its listing on the Nasdaq Capital Market, or any other national securities exchange, that the Company or its subsidiary will not be able to commercialize its products, that the FDA will not approve the initiation or continuation of the Company's clinical programs or provide market clearance of the Company's products, including products developed by Exosome Sciences, Inc., the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the Company's ability to manufacture its products either internally or through outside companies, the impact of government regulations, patent protection on the Company's proprietary technology, the ability of the Company to meet the milestones contemplated in its contract with DARPA, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended March 31, 2015, and in the Company's other filings with the Securities and Exchange Commission. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.
Mike Smargiassi/Brad Edwards
Brainerd Communicators, Inc
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SOURCE Aethlon Medical, Inc.
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Researchers at the Icahn School of Medicine at Mount Sinai say that tiny doses of a cancer drug may stop the raging, uncontrollable immune response to infection that leads to sepsis and kills up to 500,000 people a year in the U.S. The new drug treatment may also benefit millions of people worldwide who are affected by infections and pandemics.
Their study reported in Science, demonstrates in both cells and animals that a small dose of topoisomerase I (Top 1) inhibitor can dampen an acute inflammatory reaction to infection while still allowing the body's protective defense to take place. The title of the study is "Topoisomerase 1 inhibition suppresses the transcriptional activation of innate immune responses and protects against inflammation-induced death."
The treatment may help control not only sepsis -- deadly infections often acquired in hospital by patients with a weak immune system -- but also new and brutal assaults on human immunity such as novel influenza strains and pandemics of Ebola and other singular infections, says the study's senior investigator, Ivan Marazzi, PhD, an Assistant Professor of Microbiology at the Icahn School of Medicine at Mount Sinai.
"Our results suggest that a therapy based on Top 1 inhibition could save millions of people affected by sepsis, pandemics, and many congenital deficiencies associated with acute inflammatory episodes -- what is known as a cytokine, or inflammatory, storm," says Marazzi.
"These storms occur because the body does not know how to adjust the appropriate level of inflammation that is good enough to suppress an infection but doesn't harm the body itself," he says. "This drug appears to offer that life-saving correction."
Sepsis is caused by an excessive host response to infection, which in turn leads to multiple organ failure and death. With an overall mortality rate between 20 and 50%, sepsis is the tenth leading cause of death in the U.S. -- it kills more people than do HIV and breast cancer.
"To date there has been no targeted treatment for sepsis, or for other infections that promote this inflammatory storm," says Dr. Marazzi. "Such treatment is desperately needed."
For example, sepsis is a leading cause of death in infants and children, he says. "Septic shock and lung destruction can occur when a child is suffering from a pneumonia caused by co-infection with a virus and a bacteria even when antibiotic therapy is being used. The elderly are also especially vulnerable to sepsis."
Following a challenge from the National Institutes of Health to repurpose existing drugs for new uses, the research team used a simple cellular screen to find candidate drugs that could tamp down rampant inflammation.
They discovered that the Top 1 inhibitor class of cancer drugs -- four have been previously approved for a variety of cancers -- also blocks a set of genes that are activated immediately by immune cells to combat an infection. "These genes are the ones that have the strongest inflammatory effects," says Marazzi.
The Mount Sinai team found that use of one to three doses of a Top 1 inhibitor that is 1/50th the strength of normal chemotherapy was enough to rescue 70-90 % of mice from an inflammatory storm death due to either acute bacterial infection, liver failure, or virus-bacteria co-infection. The treatment did not produce overt side effects.
They also tested the inhibitor in cells infected with influenza, Ebola, and other viral and bacterial microbes that over-stimulate the immune system, and found the drug blunted a dangerous immune reaction.
"We observed a striking effect of Top-1 inhibitors on expression of pro-inflammatory molecules induced by Ebola virus infection. This study contributes our understanding of pathogenesis of Ebola virus disease and also suggests a direction to develop treatments," says Alexander Bukreyev, PhD, Professor in the Department of Pathology and Microbiology & Immunology at the Galveston National Laboratory at the University of Texas Medical Branch.
"Finding remedies for these infection-induced inflammatory storms is a global focus, and we look forward to testing the ability of Top-1 inhibitors to save lives," adds Marazzi.
Taking aspirin could increase cancer survival by 20 percent
Study prompts call for more research into aspirin as an additional cancer treatment
April 20, 2016
Patients receiving cancer treatment could increase their chance of survival by up to 20 percent and help stop their cancer from spreading by taking a low dose of aspirin, new research suggests.
Patients receiving cancer treatment could increase their chance of survival by up to 20% and help stop their cancer from spreading by taking a low-dose of aspirin, new research suggests.
In a systematic review of the available scientific literature a team from Cardiff University's School of Medicine found a significant reduction in mortality and cancer spread by patients who took a low-level dose of aspirin in addition to their cancer treatment (average study follow-up length over 5 years).
"There is a growing body of evidence that taking aspirin is of significant benefit in reducing some cancers," said Professor Peter Elwood who led the research published in the journal PLOS ONE.
"Whilst we know a low-dose of aspirin has been shown to reduce the incidence of cancer, its role in the treatment of cancer remains uncertain. As a result, we set out to conduct a systematic search of all the scientific literature."
The team's review looked at all of the available data including five randomised trials and forty two observational studies of colorectal, breast and prostate cancers.
Professor Elwood said: "Our review, based on the available evidence, suggests that low-dose aspirin taken by patients with bowel, breast or prostate cancer, in addition to other treatments, is associated with a reduction in deaths of about 15-20%, together with a reduction in the spread of the cancer.
"The results from six studies of other cancers also suggest a reduction, but the numbers of patients were too few to enable confident interpretation. A mutation -- known as PIK3CA
April 20, 2016 Sepsis, more commonly known as blood poisoning, is an exceptional healthcare problem. It is more common than heart attacks, and kills more people than any type of cancer and despite this, it remains largely unknown. According to a 2013 paper published in The New English Journal of Medicine1, it affects more than 19 million people around the world yearly and the number keeps increasing. There is hope for a reliable treatment, however, as researchers at the IBS Center for Vascular Health have developed a targeted therapy for mitigating sepsis by strengthening as well as protecting blood vessels.
Sepsis is caused by the immune system severely overreacting to an infection and attacking itself. The first thing that occurs is the weakening of blood vessels which makes them porous and causes vascular leakage leading to a cascade of compounding negative effects, including severe inflammation, organ damage, pulmonary edema and death. Since sepsis doesn't have a cure, instead of treating its symptoms head on doctors are only able to fight the underlying infection and hope that the body gets strong enough to combat the sepsis on its own.
The IBS team's new method for alleviating sepsis progression focuses on activating a receptor in the lining of blood vessels called endothelial cells. They induced a protein growth factor called Tie2, which stimulates blood vessel growth by using an anti-angiopoietin-2 (Ang2) antibody, called ABTAA (Ang2-binding and Tie2-activating antibody).
ABTAA works by simultaneously causing Ang2 inhibition and Tie2 activation. Under normal conditions, Ang2 is barely detectable in the body but during times of high stress (like a severe infection) it is created en masse and circulates through the bloodstream causing vascular cell death and making the blood vessels porous. ABTAA prevents this by causing Ang2 to clump together rendering it inert and unable to cause damage and also stimulating Tie2 which strengthens blood vessels. Also, encouragingly, the combination of ABTAA and antibiotics enhanced the survival rates of severe sepsis models up to 70%.
IBS researcher Seung Jun Lee uses his new process to "strengthen the blood vessels so the body has a stable environment to fight the infection which also prevents further damage." Using ABTAA will likely become a therapeutic treatment for sepsis and by eliminating the effects brought on by the immune system's severe overreaction; fatality from sepsis no longer appears to be inevitable. Lee said, "In the past, treating sepsis meant fighting off the underlying infection but the immune system still attacked itself and people still died." ABTAA is a separate, independent treatment which eliminates the root cause of sepsis so the body has a strong battlefield to fight the infection. Use in sepsis treatment may be just the start for ABTAA. Heart attacks also cause major stress on the body which results in Ang2 production, and by reducing Ang2 production, ABTAA could alleviate the severity of the attacks and increase survivability. Even more intriguing is the possibility for ABTAA to be used as part of a cure for life-threatening infections such as the Ebola or MERS viruses since both are known to cause devastating disintegration of vascular systems.
1 D. C. Angus, T. van der Poll, Severe sepsis and septic shock. N Engl J Med 369, 840- 851 (2013).
BARCELONA, Spain — What started with a single patient with hepatitis C insisting that he would take generic direct-acting antiviral medication imported from China with or without the help of his doctor blossomed into a global clinical trial that is curing patients at a fraction of the cost of brand-name therapies.
In fact, interim results from the ongoing REDEMPTION-1 study show sustained viral response at 4 weeks with generic treatments for chronic hepatitis C virus. The findings, presented during a late-breaking session here at the International Liver Congress 2016, were met with resounding applause.
"Generic versions of sofosbuvir, ledipasvir, and daclatasvir are being mass produced for 1% of the current retail price in the United States," said lead investigator James Freeman, MD, from GP2U Telehealth in Hobart, Australia. But "in what must be one of the greatest tragedies of modern times, these lifesaving medications are not being deployed on a mass scale."
To date, 448 of the patients enrolled in REDEMPTION-1 have been treated with generic products. Generic sofosbuvir was used in combination with generic ledipasvir in 45.8% of the patients, with generic daclatasvir in 42.6%, with generic daclatasvir plus brand-name ribavirin in 6.0%, with generic ledipasvir plus brand-name ribavirin in 4.7%, and with brand-name ribavirin in 0.9%.
Most patients (63.9%) were infected with genotype 1 disease, but 27.5% were infected with genotype 3. Mean age was 54.4 years.
"This is quite a sick cohort of patients," Dr Freeman explained. Nearly 50% of the patients were treatment-experienced, and 31.3% had cirrhosis.
The interim analysis involved 236 of the patients who had completed a course of treatment. Overall, the percentage with viral titers at the lower limit of quantification was 99.6%. For sofosbuvir plus ledipasvir, it was 99.2%; for sofosbuvir plus ledipasvir, it was 100%; and for sofosbuvir plus daclatasvir, it was 100%.
Sustained viral response 4 weeks after treatment, available for 144 patients, was 94.4% overall, 93.7% for sofosbuvir plus ledipasvir, and 97.4% for sofosbuvir plus daclatasvir.
In terms of safety, "no new or unknown side effects were reported, with headache, fatigue, and insomnia being the most common," Dr Freeman reported.
All four deaths in the study cohort were related to hepatocellular carcinoma.
Three patients with compensated cirrhosis temporarily decompensated on treatment initiation but were able to continue. All four deaths in the study cohort were related to hepatocellular carcinoma; one patient died before hepatitis C treatment began, two withdrew early in the course of treatment and entered palliative care, and one died before sustained viral response at 4 weeks could be assessed.