Pfizer has launched a competitive, peer-reviewed grants program to support clinical research projects investigating Ibrance (palbociclib) in advanced breast cancer.
Saturday, March 19, 2016
SIMPLE MISTAKE MADE IN STUDY LEADS TO SEX BIAS BREAKTHROUGH IN MULTIPLE SCLEROSIS.
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.
Source: Northwestern University
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 thestar.com
“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 www.base.cctam.ca/.
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 www.synergypharma.com.
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.
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Hi,I,m Basim from Canada I,m physician and I,m interested in clinical research feild and web development.you are more welcome in our professional website.all contact forwarded to basimibrahim772@yahoo.com.
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