In another small -
scale trial for multiple sclerosis, treatment appeared to reverse the disease's progression and its associated disability, a further historic first.
Another major pharma player, Roche, canceled its BACE1 research back in 2013, but several large -
scale trials for BACE1 inhibitors are still currently in development or underway.
Not exact matches
While the new mid-stage study results from DNDi were impressive (they showed cure rates of 96 % to 97 % even
for the sickest patients and those with liver scarring), more late - stage
trials will be necessary before the drug is available on a large
scale in the developing world.
If large -
scale trials can replicate safety and efficacy results, the drug could be approved
for legal use by 2021.
Our highly skilled technicians combined with our laboratory -
scale processing equipment reduce the need
for large plant
trials and accelerates the development of your product and speed to market distribution.
«Protein in breast milk reduces infection risk in premature infants: Study shows need
for large -
scale trial of lactoferrin's role in immune system development.»
«Our results justify the need
for a large -
scale trial of lactoferrin, as well as its counterpart derived from cow milk, bovine lactoferrin.»
The Department
for Work and Pensions (DWP) quietly published a large -
scale trial of the scheme last year.
By late 2012, it adds, «the department had largely stopped developing systems
for national roll - out and concentrated its efforts on preparing short - term solutions
for the pathfinder» (the small
scale trial of the system).
The drug is undergoing testing at a 3 milligram (mg) dose
for long - term weight management as part of the
SCALE ™ (Satiety and Clinical Adiposity — Liraglutide Evidence in Nondiabetic and Diabetic Subjects) Obesity and Prediabetes
trial.
An NIH - backed vaccine is among several heading
for human
trials, but the timeline
for large -
scale deployment remains murky
This year, Rocke hopes to conduct larger -
scale field
trials to determine the levels of immunity required
for success in a mass vaccination.
The
SCALE Obesity and Prediabetes
trial is continuing
for two more years
for the prediabetic subjects in arm 2.
The drug is not approved
for weight management, according to its manufacturer, Denmark - based Novo Nordisk, which sponsored this study, called the
SCALE ™ (Satiety and Clinical Adiposity - Liraglutide Evidence in Nondiabetic and Diabetic Subjects) Obesity and Prediabetes
trial.
That year, Targacept reported that in phase II
trials with an approved antidepressant, TC - 5214 had few side effects and produced a six - point improvement on the Hamilton rating
scale for depression.
A panel of scientists said there was no scientific justification
for this large -
scale trial of a single product and the money has now been handed to the National Institutes of Health to compare several vaccines instead.
This vaccine has been at the heart of a controversy in the US after Congress awarded the defence department $ 20 million to test it in large -
scale trials in America as an immune therapy
for HIV - positive people.
«We don't know what exposure is leading to this susceptibility to dietary glutamate, but this pilot study suggests the need
for a large -
scale clinical
trial, since dietary change could be an effective low - cost treatment option
for developing countries.»
We also have a large -
scale biologics manufacturing facility in Rensselaer, New York, where we produce commercial and investigational products
for clinical
trials, and a satellite office in Basking Ridge, New Jersey.
The controversy came to a head in March when the National Institutes of Health issued a notice of a competition soliciting participation in a large -
scale clinical
trial to evaluate the effectiveness of fetal surgery as a treatment
for spina bifida.
For example, this could support large -
scale epidemiologic studies or remote pharmacological
trials,» said senior and corresponding author David L. Kaplan, Ph.D., Stern Family Professor in the Department of Biomedical Engineering at Tufts School of Engineering.
Graham looked to the Internet
for treatment options and came across Duke University oncologist Keith Sullivan, who was comparing standard chemotherapy and stem cell therapy as part of a large -
scale clinical
trial for scleroderma.
When people with early - stage symptoms took omega - 3 supplements
for three months, they had much lower rates of progression than those who did not, according to one small -
scale trial.
Those encouraging findings from the small -
scale pilot study formed the basis
for this multi-center clinical
trial led by Carley and Zee.
While a postdoctoral fellow at the Naval Medical Research Institute in Bethesda, he developed a system
for large -
scale efficient culture of lymphocytes that has proved to be the foundation
for over 35 early phase clinical
trials of adoptive immunotherapy.
«This risk
scale provides an inexpensive and easy way
for doctors to identify people who should be referred to more advanced testing
for memory issues or may be better candidates
for clinical
trials,» said Petersen.
This is a very promising finding that provides an excellent basis
for future larger
scale trials using the intervention in very early development.»
To make up
for those shortcomings, the report called
for a research program, including smaller
scale field
trials, whose goal «should be to improve understanding of the range of climate and other environmental effects of albedo modification, as well as understanding of unintended impacts.»
Larger
scale clinical
trials are currently being planned to pave the way
for eventual release to the market.
At the meeting, GlaxoSmithKline (GSK) of Rixensart, Belgium, which has the vaccine furthest in development, spelled out how it might
scale up production in parallel with the safety and efficacy
trials now under way so that the product could be ready
for wider distribution by April if warranted.
In 2002, the research team
for TRIGR (
Trial to Reduce IDDM in the Genetically at Risk), led in the U.S. by principal investigator Dorothy Becker, M.D., professor of pediatrics at Children's Hospital and the University of Pittsburgh School of Medicine, embarked on a large -
scale study of 2,159 infants with a family member affected by type 1 diabetes and with genetic risk
for type 1 diabetes to find out whether delaying the exposure to complex foreign proteins such as cow's milk proteins would decrease the risk of diabetes.
Ashikaga cautions that larger -
scale clinical
trials are needed before the measurement can be recommended
for wider use.
It worked well in a pilot test in Washington, D.C., and an international consortium has been organized
for a large -
scale trial in Costa Rica.
Moving forward, the NUS team intends to carry out larger
scale trials to establish the full potential performance of sand
for impact resistance.
If the
trials are successful, they could open the way
for full -
scale development of the air - breathing rocket engine.
«While the results of this study are preliminary, they hold promise
for enhancing and maintaining brain reserve in later life, particularly among sedentary individuals who may benefit most urgently from behavioral interventions like Experience Corps,» said Carlson, who is now leading a larger fMRI
trial as part of a large -
scale randomized
trial of the Baltimore Experience Corps Program.
iBET's infrastructure comprises 16 laboratories fully equipped with state - of - the - art technology (70 m2 each), including a BSL2 laboratory
for working with viruses; a GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority)
for quality control and batch release of human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs; a GMP Mass - Spectroscopy Unit that provides state - of - the - art MS services to the scientific community and Industry; a 2600 m2 bio-pilot plant supporting production and purification of proteins ATMPs and vaccines from bench top to 300 L
scale and privileged access to GeniBET Biopharmaceuticals, an iBET spin - off producing ATMPs under cGMP certification
for phase I / II / III clinical
trials.
Although these platforms can be used successfully
for small -
scale expansion of hMSCs, other platforms will be required to generate the quantity of cells required to support the increasing number of clinical
trials utilizing hMSCs and the subsequent large -
scale production.
This service is
for the moment only available
for staff at Uppsala University, during a
trial period, since we wish to try this approach in a small
scale to begin with.
Dr. Shoyele plans to continue the research with comprehensive toxicity tests and
scaling the nanoparticle manufacturing process
for clinical
trials.
Also scheduled
for this fall is a large -
scale clinical
trial of an HIV vaccine, which will be conducted in South Africa and co-funded by NIH.
They will perform preliminary studies to prepare
for large -
scale testing, conduct related studies to support specific
trials, provide mentoring
for junior faculty, and help recruit appropriate patients to Network
trials, especially those expected to have a significant positive impact on cancer treatment.
Showing correlations of sensor data with existing clinical
scales in a
trial setting is a prerequisite
for leveraging such data in clinical practice and drug development.
If successful, this method will be tested at
scale by an industrial partner who will generate clinical - grade material
for a Phase 1
trial at the end of this five - year grant.
They noted that the present findings warrant a confirmatory clinical
trial for SMA rTMS on PD, undertaken on a larger
scale.
A Clinical Core has capability to safely and efficiently distribute clinical studies of vaccine immunosafety
for biomarker discovery from small intensive
trials to large -
scale studies of adult, paediatric and other populations.
However, with few exceptions, the stem cell and regenerative medicine industry has remained inadequately capitalized to carry out large -
scale clinical
trials independently, and major pharmaceutical firms have tended to show more interest in the use of hiPSCs as a source of large, pure populations of specific somatic cells
for use in drug compound screening and toxicology tests, than they have in therapeutic uses of stem cells and their derivatives.
Dr. Rocke is currently leading a large -
scale field
trial in 8 western states of the U.S. to determine if oral vaccination through consumption of vaccine - laden baits prevents plague in wild prairie dogs, thus reducing the risk of disease
for the endangered black - footed ferret, other animals, and possibly humans.
Although the swine - flu shot has successfully made it through clinical
trials, has been approved by the Food and Drug Administration, and has been deemed safe
for people with weakened immune systems, its large -
scale distribution hasn't yet been evaluated.
We need to be spending a billion dollars
for high - quality long - term big -
scale randomized, controlled
trials, but most of the research we do in nutrition suffers from a shoestring budget.