An expert is one who knows more and more about less and less until he knows absolutely everything about nothing

Showing posts with label News. Show all posts
Showing posts with label News. Show all posts

Tuesday, February 14, 2017

‘Magic’ blood test could make bone marrow transplants for blood cancer safer

A blood test could help predict the risk of complication following a bone marrow transplant in some blood cancer patients, according to a new US study.
The test could help identify which patients given a transplant are likely to develop a potentially fatal complication, the researchers report in The Journal of Clinical Investigation Insight
(link is external)

"The test worked in different hospitals and in different groups of patients in the US and Europe, suggesting that it could be used widely" – Professor Ronjon Chakraverty, Cancer Research UK
In doing so, the test could “allow early intervention and potentially save many lives”, said lead researcher Professor James Ferrara from Mount Sinai School of Medicine(link is external)
Bone marrow transplants, in which a patient’s blood stem cells are replaced with those from a donor, are given to some patients with blood cancer to cure their disease. But around half of patients who receive the procedure develop a serious and often fatal complication called graft-versus-host disease (GVHD). 
This happens when the donated immune cells recognise the patient’s body as a threat and launch an attack against it, causing inflammation that sometimes doesn’t respond to treatment. 
For this latest study, researchers from 11 cancer centres in the US and Europe looked at blood samples from almost 1,300 bone marrow transplant patients to see if they could predict whether a patient will develop GVHD, and also their outlook.
They developed a test, called ‘MAGIC’ (Mount Sinai Acute GVHD International Consortium), looked at four different molecules in the blood. The researchers found that measuring the levels of two of these molecules – ST2 and REG3a – just one week after the transplant procedure, could help identify those at high risk of developing the complication and dying. 
Researchers at Mount Sinai are now using these results to design clinical trials looking into whether certain immunotherapy drugs, normally given at the onset of GVHD, could improve the outlook for some patients if given earlier on, after the test identifies them as high risk. 
Professor Ronjon Chakraverty(link is external), a Cancer Research UK expert on stem cell transplants, said: “This study reveals that a blood test performed just one week following a bone marrow transplant accurately identifies which patients are at the greatest risk of this life-threatening condition. 
“Importantly, the test worked in different hospitals and in different groups of patients in the US and Europe, suggesting that it could be used widely. Tests such as this could spot patients who are most at risk, and make sure they get special targeted treatment before GVHD develops.”


Hartwell, M. J. et al. (2017). An early-biomarker algorithm predicts lethal graft-versus-host disease and survival. JCI Insight. 

Saturday, March 19, 2016

Smoking vaccine fails clinical trials, $4.1 million in taxpayer dollars down the drain

An experimental new anti-smoking vaccine has failed miserably in clinical trials, faring no better than a placebo shot at helping people to quit smoking.Produced in partnership with drug giant GlaxoSmithKline (GSK), Nabi Biopharmaceuticals’ NicVAX was intended to help people quit smoking by triggering the production of antibodies that would attach to nicotine and prevent the substance from reaching the brain — but the vaccine has proven to be nothing but non helpful medicine.
According to reports, the yearlong study involved 1,000 people that were given either NicVAX or a placebo shot, and who were tracked to observe smoking habits following treatment. Roughly 11 percent of patients who received the NicVAX shot quit smoking, but the same amount from the placebo group also quit smoking — in other words, there was no difference at all in quit rates between the two groups. Upon news of the failed Phase III trial, Nabi’s stock price dropped a massive 70 percent, and GSK’s dropped about one percent. But what is even more shocking is the fact that Nabi had used $4.1 million in taxpayer dollars to fund research for NicVAX. The company’s website openly discloses that the US National Institute on Drug Abuse (NIDA) had granted $4.1 million in funding to the company back in 2005 for the project.
Remember, both Nabi and GSK are private, for-profit drug companies, and GSK had a net income in 2010 of nearly $3 billion. And yet the US government decided to take Americans’ hard earned money and funnel it into a failed project that, if eventually “successful” (at least in terms of somehow gaining FDA approval, not in terms of actually working to “cure” smoking), will translate into $500 million in profits for Nabi, and possibly even more for GSK.

Researchers discover exciting new line of stem cells by accident

The already exciting prospect of stem cell research has just got a little more exciting, with the discovery of a new line of “more robust and easily manipulated” embryonic stem cells, completely by accident.A team of researchers from the University of Missouri came across the new cell type during studies into the causes of pre-eclampsia, a rare and complex condition which affects only pregnant women. It requires emergency caesarian early on in pregnancy to save both mother and child and it’s causes are currently attributed to a variety of factors, including shallow placentas.
“We can use these new stem cells for future research to better understand how embryos are organised and what causes diseases like pre-eclampsia and other prenatal problems.” said Michael Roberts, a Curators Professor of Animal Science and a Professor of Biochemistry. “These new stem cells made us realise that embryonic stem cells exist in a number of different transitional states, and it should open the door for future stem cell research that is much more efficient.”
The stem cells, termed bone morphogenetic protein (BMP)-primed stem cells by the team, were accidentally discovered during the growth of placenta cells. As part of their study, Roberts and his colleagues were attempting to grow placenta cells from embryonic stem cells by adding a substance called BMP-4, a protein which helps define axes of growth in embryo development, for a shorter timeframe than had previously been studied. Instead of forming placenta cells, however, the stem cells grew into what was a previously unobserved state – “BMP primed”.
They found these cells were much easier to work with in the laboratory than traditional stem cells, due to easier growth and them expressing their genes in a similar way. Embryonic stem cells as a whole are of increasing interest in research, due their ability to develop into a number of different cell types such as muscle, bone or skin.

Affordable Care Act to Cover Breast Cancer Risk Reduction Drugs

On the heels of a new recommendation from the United States Preventive Services Task Force (USPSTF), and in line with the Affordable Care Act’s coverage of prevention services, the federal government has announced that beginning in September most health insurance plans will be required to provide breast cancer risk reduction medications free of charge to high-risk women.
 Two drugs, tamoxifen and Evista (raloxifene), are offered for breast cancer risk reduction, also known as chemoprevention. These medications can reduce the risk of invasive breast cancer by about 40 to 50 percent—but not without potential side effects. Both drugs increase the risk of blood clots, and tamoxifen increases the risk of uterine cancer.
The USPSTF recommendation, published in the Nov. 19, 2013, Annals of Internal Medicine, advises doctors to discuss chemoprevention with high-risk patients for whom the drugs’ potential benefits outweigh their risks.
Currently, only a small number of high-risk women choose chemoprevention. A study published in the February 2010 Cancer Epidemiology, Biomarkers & Prevention by Erika Waters, a psychologist at the School of Medicine at Washington University in St. Louis, and her colleagues found that close to 121,000 U.S. women who had not had breast cancer were taking tamoxifen in 2000 for risk reduction. By 2005, the number had dropped to about 51,000. Yet based on data from the National Health Interview Survey, Waters found that 10 million U.S. women would have been classified as eligible for tamoxifen in 2000—and for 2.4 million of these women, the benefits of the drug would have outweighed the risks.
The USPSTF recommendation has the potential to increase the number of high-risk women who choose to take tamoxifen, says Waters, “but maybe not in the way people expect. I think what the recommendations will do is alert clinicians and primary care physicians to the availability of the drugs, which [might then] make them more likely to offer the treatment to a high-risk woman.”For women considering whether to take these drugs, she says, the USPSTF recommendation is likely to have some weight, but “it will be only one of many factors women consider.” Similarly, she says, while the ACA coverage may help low-income women who have already decided to take tamoxifen or Evista, “just because it is free is not going to change someone’s mind if they are worried about the side effects.”
Waters also stresses the need to put the benefit of chemoprevention in perspective. “Tamoxifen can reduce risk of developing invasive breast cancer by 50 percent, and it is estimated that about one-third of postmenopausal women would be eligible to take it,” she says. “But … physical activity, not gaining weight, and losing weight if overweight can also reduce breast cancer risk up to 50 percent.” There are other ways to reduce breast cancer risk beyond taking medication, Waters says, and it’s important for health care providers to tell women about these options so that they can take them into consideration when thinking about their treatment decisions.

Cancer Risk Reduction and the ACA
Under the Affordable Care Act, most health care plans will cover preventive services without requiring a copay or coinsurance, even if you have not met your annual deductible. This includes cancer prevention and screening services such as:
• Alcohol misuse screening and counseling
• Breast cancer chemoprevention counseling and treatment for high-risk women
• Breast cancer genetic counseling for high-risk women
• Cervical cancer screening
• Colorectal cancer screening
• Human papillomavirus (HPV) vaccination
• Mammography
• Obesity screening and counseling
• Tobacco use screening and cessation interventions

Investigating a Novel Combination of Treatments for MS Patients

Frequently utilized MS treatments are prescribed with the goal of disease stabilization. However, they may share a common deficiency: lack of effectiveness in addressing many of the symptoms associated with the disease. Additionally they may lead to a troubling array of side effects which in themselves can negatively impact quality of life.
Newer treatments are now being investigated that seek to address many of the most debilitating symptoms related to MS. Since these novel therapies do not involve long-term treatment with pharmacological agents, they present a possible option for MS patients who are either unable to tolerate the side-effects of MS medications or who are unsatisfied with the results of their current therapies.
Dr. Michael Arata of Autonomic Specialists in Newport Beach, California has been investigating a therapeutic approach that targets many of the more troublesome symptoms suffered by MS patients, particularly those related to autonomic dysfunction (including brain fog, fatigue, headaches upon awakening, bladder and bowel problems, and inability to thermoregulate). This endovascular therapy, called Transvascular Autonomic Modulation (TVAM), has been shown to improve symptoms in a majority of patients, according to research published in Acta Phlebologica.
More recently, Dr. Arata has been investigating a surgical treatment involving the use of adult mesenchymal stem cells in conjunction with the Cell Surgical Network. This treatment involves mesenchymal stem cells in a stromal vascular fraction (SVF) that is produced from the patient’s own fat cells (extracted via a mini-liposuction procedure).
Mesenchymal stem cells and growth factors contained in SVF are known to have strong anti-inflammatory properties. Mesenchymal stem cells also have the capacity to remain dormant until they reach an area of injured or damaged tissue.
Now Dr. Arata is investigating an approach for patients with MS that includes both TVAM therapy and the SVF/mesenchymal stem cell treatment in a single outpatient visit.
It is possible that including both mesenchymal stem cell therapy and the TVAM procedure may lead to an enhanced effect. Therapeutic synergy might be achieved through both the anti-inflammatory effects of the SVF and the reparative capabilities of mesenchymal stem cells along with enhanced autonomic function seen in patients following TVAM.

Dr. Arata responds personally to Facebook comments between the hours of 3:30-5pm PST on Thursdays and throughout the week as his schedule permits.

Diabetes Drug Metformin May Lower Glaucoma Risk

The diabetes drug metformin was linked to a lower risk of developing the eye condition glaucoma in a new study.People who took the most metformin during the 10-year study period had a 25 percent reduced risk of glaucoma compared with people not taking the drug, researchers found.
“Glaucoma is a leading cause of blindness worldwide and classic open-angle glaucoma develops in late middle age or late age. So we hypothesized that a drug that mimics caloric restriction, such as metformin, might reduce the risk of glaucoma,” said lead researcher Julia Richards, a professor of ophthalmology and visual sciences at the University of Michigan in Ann Arbor.
Exactly how metformin might reduce the risk of glaucoma isn’t known, the researchers said. And, while this study found an association between metformin use and lower glaucoma risk, it wasn’t designed to prove a cause-and-effect relationship.Dr. Mark Fromer, an ophthalmologist at Lenox Hill Hospital in New York City, explained that glaucoma is caused by too much fluid in the eye, when fluid doesn’t drain adequately, or when the blood vessels in the optic nerve are damaged. “Somehow metformin is affecting one of those conditions,” he said.Fromer pointed out that although the results of this study are impressive, using metformin to prevent or treat glaucoma in non-diabetic patients is problematic. Metformin could drop blood sugar too low in people without diabetes, he said.
“People without diabetes should not be taking metformin,” he said. “If not monitored carefully by a doctor, it can have significant consequences,” said Fromer, who was not involved with the study.Richards, however, said that it might be possible to use metformin as a treatment for glaucoma even in people without diabetes.“But since this study was done in a diabetic population, the conclusions are currently limited to this population,” she said. “Further work, such as a clinical trial, would be needed to tell if this could be extended to non-diabetic populations or used to prevent progression of glaucoma in those who already have the disease,” Richards said.The study was published online May 28 inJAMA Ophthalmology.
For the study, Richards and colleagues collected 10 years of data on more than 150,000 people with diabetes. All were 40 or older at the start of the study. The investigators found that 4 percent of the participants developed glaucoma.The researchers said that people taking the highest amount of metformin (more than 1,110 grams in two years) had a 25 percent reduced risk of developing glaucoma compared with those not taking the drug.For every 1-gram increase in metformin taken, the risk was reduced by 0.16 percent. The researchers estimated that taking a standard dose of metformin (2 grams per day) for two years would reduce the risk for glaucoma by 21 percent.This risk reduction was seen even after accounting for lower blood sugar levels, the study authors said. Other diabetes drugs were not associated with reduced risk of glaucoma, they added.

WHO draws lessons from Ebola to prepare roadmap for future epidemics

The World Health Organization (WHO) has concluded a meeting on Ebola R&D to look at lessons learned from the outbreak and develop a roadmap for future epidemics. Dr. Marie-Paule Kieny, WHO assistant director-general for health systems and innovation, said the Geneva meeting aimed to “come up with a new framework for R&D for diseases with epidemic potential and other health threats, so that next time we can be better prepared, faster and more effective.” Kieny said, “If something like Ebola ever happens again, the world needs to be ready with a blueprint for an R&D preparedness plan with clear rules, platforms for information sharing, established processes to expedite development and clinical trials—to activate coordinated action and limit the damage.” The meeting in Geneva, Switzerland, took place as an independent panel of experts tasked to assess the UN global health agency’s response to the Ebola outbreak in West Africa concluded in a report that “at present, WHO does not have the operational capacity or culture to deliver a full emergency public health response” and urged investments by its member states to make it fit for purpose. “Ebola is not the only epidemic-prone disease for which there are no medicines, vaccines or diagnostics. Nor is this the first time the world has been caught unprepared in the face of an epidemic,” said Kieny. “With more frequent travel, globalized trade and greater interconnectedness between countries, disease outbreaks that once used to be localized and quickly extinguished now have a much greater chance of spreading more widely. Therefore, we as a global community need to be prepared for such a possibility in the future.” To date, the Ebola outbreak in West Africa has affected more than 26,000 people and left some 11,000 dead. Dr. Margaret Chan, WHO director-general, said the Ebola R&D effort has mobilized people, institutions and resources in ways never before seen in an “otherwise horrific human calamity” and noted that the world was “likely very close to having a vaccine that can protect against Ebola.” Kieny said that thanks to “this joining of forces from all corners of the world and different sectors accelerating all actions, we now have commercial diagnostics to detect Ebola, and at least two possibly effective vaccines. These results would normally have taken five to 10 years. All this was done in less than 10 months. Even as Ebola wanes and some of the R&D efforts may not reach the goals aspired, the pioneering work done so far can be leveraged to put in place standards and best practices to improve expedited data and results sharing.”

Pfizer launches $3M grants program to further breast cancer research

Pfizer has launched a competitive, peer-reviewed grants program to support clinical research projects investigating Ibrance (palbociclib) in advanced breast cancer.
The multi-year program, which will award a total of up to $3 million in grants to investigators in the U.S., is an extension of Pfizer’s Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) initiative. It is the first ASPIRE program to focus on breast cancer research.
Ibrance received accelerated approval by the FDA in February 2015 for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
“We believe the ASPIRE Breast Cancer Research Awards will contribute important information to our body of knowledge about the role Ibrance plays in the treatment and clinical management of advanced breast cancer, and will complement the robust clinical development program we have ongoing,” said Dr. Julia Perkins Smith, senior medical director, U.S. breast cancer lead, Pfizer Oncology. “Through these awards, we also look forward to supporting the mission of the ASPIRE program to further academic research and nurture the career development of emerging investigators in a disease area of high unmet medical need.”
Grantees will be selected through a competitive application process overseen by an independent review panel of breast cancer experts.
The review panel encourages investigators (with a special interest for emerging researchers at assistant professor level or equivalent) to submit applications for innovative research in several areas. Highlights of the research of interest include:
  • Improving the medical knowledge of palbociclib in the treatment of advanced breast cancer
  • Optimizing clinical management during palbociclib treatment that addresses or improves patient compliance and convenience and/or patient reported outcomes.


An innocent mistake made by a graduate student in a Northwestern Medicine lab (they accidentally used male mice instead of female mice during an experiment) has led scientists to an exciting breakthrough that offers new insight into why women are more likely than men to develop autoimmune diseases such as Multiple Sclerosis (MS).  The data finding focuses on a type of white blood cell, the innate lymphoid cell, that exhibits different immune activities in males versus females.
The team state that MS is a disease that affects the brain and spinal cord and is the result of a dysregulated immune response. Using a mouse model of MS in which only females get disease, this study showed that innate lymphoid cells are activated and protect male mice from the disease. Although female mice have these same cells, they remain inactive and do not protect them.  They go on to add that the research opens up new avenues for investigation into sex-determined disease susceptibility and could one day lead to better therapies for both men and women with MS and other autoimmune diseases.
Women are three to four times more likely than men to develop MS, and much of the current research focuses on this fact, states the researchers.   Now, thanks to a serendipitous moment in the laboratory, the team say they are investigating why males are protected from MS.  They hypothesize that understanding the mechanisms that limit disease in men can provide information that could be used in future therapy to block disease progression in women.
Like most laboratories that study the mouse model of MS, female mice are used in almost all of the  experiments.  Previous studies have shown that when the disease is induced in this strain of female mice, virtually 100 percent of them get very sick.  Male mice either got no disease or very little, so MS researchers typically use females in their studies.
A few years ago the team ran an experiment using two groups of female mice. One group was normal; the other had a genetic mutation in a growth factor receptor (c-kit) that prevented the development of a subset of immune cells.  Previous experiments from the team showed that female mice with the mutation didn’t get as sick as normal mice, and the researchers were looking into reasons why. However, instead of using females, the graduate student accidentally chose male littermates from each group.
The results of the previous study were striking; the male mice with the mutation got very, very sick.  Because this strain of male mice never get very sick, the researcher at first thought there was some sort of mistake and repeated the experiment.  The results were the same, the team realized that the mutation was behaving differently in males and females.   The team decided to investigate these findings further.
The current study shows that mice with the c-kit mutation lacked type 2 innate lymphoid cells. These cells are normally present in bone marrow, lymph nodes and the thymus of both males and females. The researchers think that in males these cells produce a protein that may help to protect from the disease by interfering with the damaging immune response.
The data findings show that when these cells are missing in the males with the mutation, that changes the whole immune response of the male animals and causes this lack of protection.  The researchers are now looking at what activates these cells preferentially in males and not in females. The next question is can the innate lymphoid cells in females be activated to decrease disease susceptibility.
The team note that this isn’t the first sex difference study in the field of MS research. In the 1990s, scientists found that testosterone was a protective hormone for women with MS, but long-term treatment of women with MS with testosterone is not a viable option because of undesirable side effects.
Type 2 innate lymphoid cells have been well studied in allergy, where they are thought to promote allergic inflammation, state the team. However, this is the first study to show that these cells exhibit sex differences in their activity and actually can protect in autoimmune disease. Early trials are underway with the researchers hoping to find clues to explain potential activators of these cells and whether those activators can be used in therapy.
The team surmise that the data findings could lead to a new approach to designing drug therapy that modulates instead of completely suppresses the immune system of MS patients, shifting the response to one that is not so damaging.
They conclude that the hope is to target these cells in a sex-specific way and provide a therapy with fewer side effects.  This early research may have implications for understanding other diseases such as lupus and rheumatoid arthritis, which also show a female bias.

Canadian-made Ebola vaccine starting clinical trials in humans

Health Minister Rona Ambrose said trials are moving at “unprecedented speeds,” but critics slam government for not acting faster amid deadly outbreak.Clinical trials are now starting for an experimental made-in-Canada Ebola vaccine amid growing global concern over the disease that’s left more than 4,000 people dead.Federal Health Minister Rona Ambrose called the trials “promising news” in the fight against the largest-ever Ebola outbreak. As part of a process Ambrose said is moving at “unprecedented speeds,” results of the first phase are expected in December, and the hope is the vaccine can be deployed shortly thereafter.At this time, however, it’s unclear if the vaccine will ever reach people on the ground in West Africa — and critics say the trials didn’t happen nearly fast enough.
More at
“This is a shameful delay,” said Amir Attaran, a University of Ottawa professor and Canada Research Chair in law, population health, and global development policy. “The competing vaccine is way ahead of where we are, and that worries me,” he added. That second experimental vaccine is being produced by pharmaceutical giant GlaxoSmithKline alongside the U.S. National Institute of Allergy and Infectious Diseases, and human trials have already started in Africa. The Canadian vaccine — which many scientists consider the more promising of the two — was developed by researchers at the Public Health Agency of Canada’s National Microbiology Laboratory. Ambrose said it has been “100-per-cent effective” in preventing the spread of the Ebola virus when tested on animals. The Canadian government owns the intellectual property associated with the vaccine and has licensed the rights to a small American company, NewLink Genetics, through its subsidiary BioProtection Systems. The first phase of human clinical trials will be conducted in a lab in Silver Spring, Md., and will test the vaccine on a small group of healthy people to assess its safety, help determine proper dosage levels and identify any side-effects. “We currently have the two vaccines that are being tested and this has created sort of a ‘space race’ to find out which vaccine is going to be the first to the finish line,” noted Toronto-based microbiologist Jason Tetro. “If one of the two vaccines is slow in advancing to trials, you’ve taken a two-horse race and you’ve made it a one-horse race,” added Attaran. He said researchers need to generate data on both vaccines as soon as possible to know which one works best — or works at all. Tetro said he appreciates the need for proper protocols when it comes to clinical trials, but he would have liked to see them happen faster.
“The fact is that we really started to be concerned about this probably four months after we should have,” he said. “And it really wasn’t until somebody … appeared on North American soil with the Ebola virus that it really took off.” By the time it became clear that a vaccine would likely be needed, it was too late to prevent the high numbers of cases and deaths, he said. There have been at least 8,400 cases of Ebola, according to the latest available numbers from the Centers for Disease Control and Prevention. Toronto emergency department physician Dr. Brett Belchetz said the Canadian vaccine’s clinical trials have been greatly accelerated when compared to typical clinical trials that may take months or even years. But he said people shouldn’t be overly hopeful about the vaccine’s potential.
“Right now, all we have are animal trials that were successful,” he said, adding there are hundreds of examples in medical literature of drugs and vaccines that were successful in animals but didn’t work for humans. But Ambrose said if this Ebola vaccine is shown to be safe and effective, “it will stop this devastating outbreak.”
“This is an excellent step towards not only putting an end to the current Ebola epidemic, but also possibly preventing all future epidemics,” noted Tetro. Dr. Gregory Taylor, Canada’s chief public health officer, stressed that no one will be at risk of contracting Ebola during this first phase of clinical trials. “The vaccine does not contain any live Ebola virus,” he said.Around 40 volunteers will be taking the vaccine and will be monitored by public health professionals for any side-effects, he said. They will also be assessed to see how well their immune systems are producing antibodies against Ebola.Taylor explained that when a person takes a vaccine, “it prompts their immune system to start making antibodies” to find and neutralize foreign objects such as viruses.
Monday’s announcement of the Canadian vaccine trials came as two patients at separate Ontario hospitals awaited Ebola test results while in isolation. One patient at Ottawa Hospital’s General Campus was “under investigation” Monday after displaying Ebola-like symptoms, but tests came out negative. That patient recently visited a West African country, according to a city of Ottawa press release.Another patient at Belleville General Hospital was also being tested for the virus. Quinte Health Care spokesperson Susan Rowe stressed that it’s “highly unlikely” the patient, who recently entered Sierra Leone, is actually carrying the virus.Health Canada said there have been no confirmed cases of Ebola in Canada.
But south of the border, a Texas health-care worker tested positive for the virus after caring for an Ebola patient who later died; in Spain, a nursing aide who contracted Ebola remains in hospital.
“I think most of us working in health care are quite afraid at this point,” Belchetz said. Various countries, including Canada, have been ramping up airport screening in major cities in an attempt to detect passengers carrying Ebola.Not all are in favour of this practice. “Airport screening is essentially useless,” said Belchetz, adding passengers could fly before knowing that they’re sick.But Tetro applauded the screening initiative. “Does that mean they’re going to find anyone? No … but it shows that the system is there,” he said.
Tetro said that screening creates a chain of communication and a record of the person’s interaction at the airport, which could prove useful if they later show up at a health-care facility with Ebola symptoms.Alongside domestic protection measures, Ambrose noted the Canadian government has committed more than $35 million in various forms of overseas Ebola aid, including a shipment of personal protective equipment last week. This shipment has now arrived in West Africa.

New portal showcases Canadian clinical research capabilities

Ottawa, ON – The Canadian Clinical Trials Coordinating Centre (CCTCC) has launched the Canadian Clinical Trials Asset Map, a pan-Canadian database showcasing Canada’s clinical research capacities.
Intended to help Canada regain its position as a leading destination for clinical trials, the online portal provides a comprehensive picture of Canada’s clinical research assets with details on clinical trial sites, research networks, research ethics boards, institutions/hospitals and individual clinical research experts.
The CCTC says it offers tremendous marketing benefits to clinical research organizations and investigators and will allow clinical trial sponsors to place trials effectively and efficiently reducing clinical trial start-up times. In addition, it is bilingual, free to use, easy to search, comprehensive and regularly updated. A forthcoming update will allow users to search by federal riding boundaries.
“The CCTAM is an important tool for enhancing Canada’s competitiveness for clinical research. The availability of this resource will simplify the study feasibility process by quickly identifying suitable clinical trial sites in Canada,” said Dr. Shurjeel Choudhri, senior vice president and head, medical and scientific affairs, Bayer Inc. “It will also be a valuable tool for highlighting Canada’s clinical research capabilities to our global organizations.”
The portal can be accessed at
CCTCC itself was launched in April 2014 and is a partnership between the Canadian Institutes of Health Research (CIHR), Canada’s Research-Based Pharmaceutical Companies (Rx&D) and HealthCareCAN. It has the overall goal of improving the coordination of clinical trial activities and streamlining regulatory processes for companies and researchers.

Canadian Clinical Trials Asset Map was launched by researchers

The Canadian Clinical Trials Asset Map was launched by researchers, industry leaders and policy-makers including, left to right, Dr. Shurjeel Choudhri, Bayer Inc., Belinda Vandersluis, director of the Canadian Clinical Trials Coordinating Centre, and Senator Kelvin Ogilvie.

Canada is aiming to regain its research edge through a new national database highlighting the country’s resources for clinical trials in the hope it will attract international companies doing research.
The Canadian Clinical Trials Asset Map (CCTAM) website went live June 4 with over 800 database records, and it is expected to grow. The map provides information on conditions and diseases being studied, and identifies gaps. For example, a search for cardiology in the system, would allow you to see all the clinical sites involved in research in that domain on a Google map. The map also documents an investigator’s specialty, trial phase and the patient population. Registration is free, although user accounts have to be pre-approved by an administrator.
The designers of the asset map say that there is oversight to ensure the information about the research sites is accurate and up to date. The website’s software finds older records and asks the owner of of the records to provide more recent data, Dr. Shurjeel Choudhri, senior vice president and head, Medical and Scientific Affairs, Bayer Inc., toldCMAJ.
“Our goal is to have something that is sustainable. It has mechanisms built within it to maintain and keep itself updated so it will be a living document that will be available to Canadians for a long time to come,” said Choudhri.
The asset map was funded and led by multiple partners, including the Canadian Institutes of Health Research, Rx&D and the advocacy organization, HealthCareCAN.
Conservative Senator, Kelvin Ogilvie, a renowned biotechnologist and researcher observed that “the number of Canadian clinical trials has been declining for over a decade.”
Ogilvie hopes the map will “at the very least stem the decline.” However, Canada faces many barriers to becoming a research leader. Not the least of these is the unwillingness of research centres to set common requirements for clinical trials. This inhibits our ability to compete with other countries in a timely fashion.
The asset map is the first tangible outcome of the 2011 Canadian Clinical Trial Summit where research-industry leaders developed a plan for improving the ability to conduct research in Canada. The summit concluded that Canada’s system is expensive and that having numerous ethical boards hinders the timeliness of trial start-ups. The online database may not speed up ethical review boards for trials, but at least all the different components involved in running a clinical trial in Canada will be available in one place.
Belinda Vandersluis, the director of the Canadian Clinical Trials Coordinating Centre(CCTCC) said Canada has a long-time reputation for conducting practice-changing, high-quality clinical trials, with internationally renowned researchers. “We don’t want to lose the reputation, the researchers, or the opportunity to study innovative and important new drugs, devices and vaccines.”
The CCTCC was established in April 2014 with a mandate to improve the clinical-trial landscape. Its $1.5 million in funding came from the same partners as the asset map. Although it only has a three-year directive, the national database will continue to run.
Pharmaceutical companies were active partners in designing the national asset map. Choudhri offered advice on how Canada can compete with other countries. “We typically have only a few weeks to identify potential sites for the trial, determine the patient population needed for that trial. By having this tool you can do a quick search and identify the sites that are active in that particular area.”
Before the national map was created, there were about 25 smaller asset maps in Canada, said Choudhri, but the data was fragmented among federal, provincial and regional bodies and some of the information was only available on paper.
“All had some gaps and a lot of them were out of date. Those were the inspiration for thinking we needed something better at a national level.”
The most up-to-date online maps were in Ontario and British Columbia. The BC Clinical Research Infrastructure Network partnered with the asset map project in offering its data. Director of Operations Heather Harris said the collaboration among provinces highlights Canada’s strengths as a whole rather than having separate agendas. “I think that it’s important to speak with that national voice.”
The asset map isn’t only for global marketing, said CCTAM Project Manager Elena Aminkova; it’s also for policy-makers. Users will soon be able to search by federal electoral boundaries as well.

Synergy Pharmaceuticals Initiates Second Phase 3 Clinical Trial of Plecanatide in Patients with IBS with Constipation

NEW YORK, June 23, 2015 — Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today the initiation of the second of two pivotal phase 3 clinical trialsevaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in patients with irritable bowel syndrome with constipation (IBS-C).
The phase 3 IBS-C program includes two randomized, 12-week, double-blind, placebo-controlled pivotal trials conducted in the United States and each trial is expected to enroll approximately 1050 adult patients with IBS-C. Patients with IBS-C are defined by Rome III Criteria as having a history of constipation and abdominal pain for at least 6 months, including hard or lumpy stools for 25% or more of defecations, loose or watery stools for 25% or less of defecations, and abdominal pain or discomfort for 3 days or more per month for the last 3 months. The primary efficacy endpoint for both trials is the percentage of patients who are Overall Responders during the 12 week treatment period. An Overall Responder, as defined by the FDA, is a patient who is a weekly responder (i.e. meets both the abdominal pain intensity reduction and stool frequency increase criteria in the same week) for at least 6 of the 12 treatment weeks.
Synergy initiated the first phase 3 IBS-C trial in December 2014. The phase 3 IBS-C program was designed to support regulatory submission in the US.

About Plecanatide

Plecanatide is Synergy’s lead uroguanylin analogue in late-stage clinical development to treat patients with chronic idiopathic constipation (CIC) and IBS-C. Uroguanylin is a naturally occurring gastrointestinal (GI) peptide produced by humans in the small intestine and plays a key role in regulating normal GI activity. Orally administered plecanatide is designed to mimic uroguanylin’s natural activity and regulate the movement of fluid required for normal digestion. Synergy recently announced positive top-line data results from the first of two pivotal phase 3 trials evaluating the efficacy and safety of plecanatide treatment in patients with CIC. The company plans to release results from the second phase 3 CIC trial in the third quarter of this year.

About Synergy Pharmaceuticals Inc.

Synergy Pharmaceuticals (NASDAQ: SGYP) is a biopharmaceutical company focused on the development of novel therapies to treat GI diseases and disorders. Synergy’s proprietary platform of uroguanylin analogues includes two late-stage clinical assets, plecanatide and dolcanatide (SP-333). Dolcanatide has successfully completed a phase 2 study in patients with opioid-induced constipation and is presently being evaluated for the treatment of ulcerative colitis. For more information, please visit
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward- looking words such as “anticipate,” “planned,” “believe,” “forecast,” “estimated,” “expected,” and “intend,” among others. These forward-looking statements are based on Synergy’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Synergy’s Form 10-K for the year ended December 31, 2014 and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Synergy does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Source: Synergy Pharmaceuticals Inc.

Investing in hepatitis C drugs could save the economy billions, researchers suggest

by Catharine Paddock PhD
Medical News Today
Researchers who examined the effect of treating hepatitis C patients with the newer generation of oral drugs suggest while these medications may cost tens of thousands of dollars for a 12-week course, they could avert billions in lost productivity.
They conclude that the higher cure rate and reduced side effects of treating hepatitis C patients with an all-oral combination of ledipasvir and sofosbuvir (LDV/SOF) led to substantially less absenteeism and better work productivity that could save economies of the US and five European countries more than $3.2 billion a year.The study featured at Digestive Disease Week 2015, an international gathering being held May 17-19 in Washington DC of clinicians and researchers from gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
Lead researcher Dr. Zobair Younossi, chairman of the department of medicine at Inova Fairfax Medical Campus, VA, says we have known for a long time about the devastating effect that chronic hepatitis C can have on patients’ health:
“But given the significant side effects previously associated with treating the disease, notably fatigue and neuropsychiatric side effects, we were interested in looking at the impact of new treatments on patients’ ability to work, and in a broader sense, how this affects employers and overall economies.”
For their study, Dr. Younossi and colleagues used data on over 1,900 chronic hepatitis C patients treated with LDV/SOF in a clinical trial. The drug combination – which interferes with enzymes that help the hepatitis C virus multiply – showed a cure rate of 94-99% with minimal side effects, they note.They contrast this with older, more traditional treatments, such as interferon and ribavirin that can have various side- effects, such as fatigue, flu-like symptoms, depression and lowered blood cell counts.The patients in their sample – including participants from the US and Europe – had filled in surveys that asked them questions specifically about work productivity, level of activity and health problems arising during the clinical trial.
The researchers gathered data not only on absenteeism but “presenteeism” where participants show up to work but are less productive.
They estimate that the reduced absenteeism and increased productivity resulting from curing hepatitis C with LDV/SOF could result in annual savings of $2.67 billion for the US and $556 million for five European countries: France, Germany, Italy, Spain and the UK.
Dr. Younossi says these are just preliminary results, and while they are encouraging, they need to be confirmed with further studies looking at the “real-world” effects on work productivity and associated economic gains outside the clinical trial setting.”Chronic hepatitis C is more than just a problem for the patient,” notes Dr. Younossi, “it has a ripple effect that impacts society at large.” He concludes:
“While previous reports have found the cost of these drugs as certainly significant, the long-term benefits of curing patients with hepatitis C makes this a worthwhile investment.”
The study was funded through a grant provided by Gilead Sciences, Inc, who market ledipasvir and sofosbuvir under the brand name Harvoni.The prices of Harvoni and other new hepatitis C drugs have been the subject of great controversy lately – with reports that the treatments are straining the budgets of both public and private payers.The debate recently took on a new twist when Sen. Bernie Sanders (I-Vt.) asked the US Department of Veterans Affairs to “invoke emergency powers to make expensive hepatitis C drugs available at affordable prices to treat tens of thousands of veterans now being denied the most effective care.”Meanwhile, Medical News Today recently learned that trials of another new course of antiviral therapy – based on a combination of daclatasvir, asunaprevir and beclabuvir – resulted in nearly all the patients with chronic hepatitis C infection becoming virus-free, including those with liver disease.

Hepatitis C treatments are ‘history in the making’ at a high cost !!

BillyBob McPherson lived on Ottawa’s streets as a young teenager before “running away with the carnival.” The 55-year-old doesn’t know exactly when during his colourful life he contracted hepatitis C — he thinks it might have been in Texas in the 1980s where he had surgery and blood transfusions while working as a carny.
But without treatment, he believes, the disease would have ended his life.Today, he is disease free, a living testament to the wonders of new drugs developed to cure the liver disease with few or no side effects. But he is also an example of the painful realities of the new  treatments.McPherson was cured because he took part in a clinical trial of the drug holkira pak, which was approved by Health Canada late last month. For 12 weeks he took nine pills a day, suffered no side-effects, and almost immediately began to feel better, he said.“These guys saved my life,” he says of the pharmaceutical company AbbVie, which developed the treatment and has held clinical trials in Ottawa, throughout Canada, and around the world.But without the benefit of the clinical trial, McPherson, who lives on a disability pension, would not have been able to afford the cure.
It is a reality Dr. Curtis Cooper, director of The Ottawa Hospital and Regional Hepatitis Program, who oversaw the AbbVie trials, deals with daily.Holkira pak, which had a 97-per-cent cure rate in clinical trials, including for patients with cirrhosis, is not yet on the market, and its price is not public. But other new drug regimes that treat and cure hepatitis C (genotype 1) without using interferon (which causes difficult side effects and is less effective), are priced well out of the range of most patients.For example, Gilead’s sofosbuvir drug, known as Sovaldi, costs $55,000 in Canada for a 12-week course of treatment, according to the company. Treatment costs to patients can be considerably higher, though, since often costly drugs are combined. One local patient with genotype 2 hepatitis C said he was told this week a combination of drugs, including sofosbuvir, taken over 16 weeks would cost $100,000.
The man is waiting to hear whether his insurance, or the drug company would cover part or all of the cost. If not, he said, he will pay for it himself.“It is literally a life-and-death situation for me. At the end of the day, it is more important to have the drug than to be worrying about the price.”Health Canada has approved three new drugs, sofosbuvir, simeprevir and harvoni since late 2013. Holkira pak was approved by Health Canada on Dec. 22, about the same time it received approval from the U.S. Federal Drug Administration.Dr. Jordan Feld, a hepatologist at the Francis Family Liver Clinic at Toronto Western Hospital, called the development of new therapies for hepatitis C “history in the making.“Hepatitis C is a devastating disease that causes more years of life lost than any infectious disease in the country. With the introduction of life-saving therapies that offer high cure rates, we can finally prevent complications of the disease and it actually raises the possibility that we even eliminate the disease from Canada altogether.”
But neither the Ontario drug plan nor many private plans cover the cost of the drugs, although simeprevir is covered under the province’s Exceptional Access Program, for some patients who meet defined criteria. AbbVie and other companies also provide drugs to some patients on a compassionate basis.Still, Cooper said he sees patients almost on a daily basis who can’t afford the cure.“It is very hard to explain to a patient that we have these great new treatment but I can’t put you on them because they are not paid for.”
Of 5,000 patients at the Ottawa Hospital clinic with hepatitis C, 100 of them are taking one of the new treatments. Some of those patients are covered by insurance that pays, or partly pays, for the treatment, said Cooper. Others receive treatment at no cost because of their circumstances and condition. Some patients, like McPherson, have benefitted from clinical trials of the drugs. A few have paid for the drugs out of their pockets.Government funding for the drugs might come too late to save the lives of some patients who could be saved now, said Cooper.
“If you have a patient who already has cirrhosis, it is really tough for them to understand they could die in the next year without getting this therapy that is Health Canada approved.”
Cooper believes Ontario, which he says has been reviewing some of the drugs for months, should immediately begin paying for treatment of patients with advanced liver disease.Hepatitis C patients have high rates of poverty, substance abuse and mental health issues — a demographic with little power. The virus, which affects 170 million people around the world, can scar the liver and lead to cirrhosis and liver cancer. Deaths are on the rise and baby boomers are considered most at risk. According to one report, two-thirds of the people with the virus are in that age group, and a large proportion is unaware of it.Cooper noted there are limited health budgets to pay for drugs, but he said the cost of paying health providers to care for hepatitis C patients year after year is also high, as is the cost of a liver transplant — between $200,00 or $300,000 — for those lucky enough to get one.McPherson knows he was lucky to get into the AbbVie drug trial. He was diagnosed with hepatitis C in the past few years but believes he had it for some time. His illness was at Stage 3, but McPherson says he was well on his way to Stage 4 and needing a liver transplant.Before being diagnosed, McPherson, who had long since quit drinking, said he felt like he had a “permanent hangover. I knew something was wrong.”That feeling went away soon after he began taking the drug regime in nine pills a day. Within two weeks of starting the trial, he said, his viral load was at zero.
“It is really remarkable.”

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Hi,I,m Basim from Canada I,m physician and I,m interested in clinical research feild and web are more welcome in my professional website.all contact forwarded to

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