Sentences with phrase «clinical safety testing»

The researchers hope to initiate clinical safety testing in humans in 2019.

Not exact matches

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

The program will involve clinical trials testing for safety in humans, followed by a larger trial using non-human primates exposed to Ebola.

NIAID then launched a clinical trial to test the vaccine's safety, and GlaxoSmithKline committed to making 10,000 doses for health care workers by the end of 2014.

Although gene therapy research has made great strides in recent years, it has yet to be widely deployed, and no CRISPR - edited genes have yet been tested for safety or efficacy in human clinical trials.

But given its low cost, availability and safety history further study in a clinical trial to test its effectiveness against Zika virus in humans is merited.»

ACT is now performing early - phase clinical trials testing the safety of implanting retinal cells derived from human ES cells into the eye to treat certain types of blindness.

Clinical trials that specifically test ADAR1 - targeted therapeutics for their safety and efficacy against multiple myeloma are still necessary before this approach could become available to patients.

Their results, published this week in the journal Biomedical Optics Express, from The Optical Society (OSA), may yield a cheaper and less invasive initial screening test for colon cancer that could complement colonoscopy, though further clinical trials will need to demonstrate the safety and effectiveness of the blood test before it is routinely used.

Designed to test the safety and effectiveness of this new approach, the clinical trial was led by principal investigator Richard Andersen, the James G. Boswell Professor of Neuroscience at Caltech, neurosurgeon Charles Y. Liu, professor of neurological surgery, neurology, and biomedical engineering at USC, and neurologist Mindy Aisen, chief medical officer at Rancho Los Amigos.

By 2010, the company had launched a clinical trial in Europe and Asia to test the safety of an anti-TFPI monoclonal antibody called concizumab.

Following the success of this preliminary safety and feasibility study, more patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.

The company hopes that early next year it will initiate clinical trials on product safety, which will pave the way for human efficacy testing that could be completed by 2011.

Despite a lack of rigorous clinical trials to test safety or efficacy, a ban of the treatment by health authorities, and a lack of peer review by the scientific community, the privately funded Stamina Foundation has been using cultured mesenchymal stem cells that have been exposed to putative conditions that favour neuronal differentiation to treat different diseases in severely or terminally ill patients.

Clinical tests could begin in a few years after safety testing.

In a phase 1b clinical trial with 21 patients, researchers tested the safety and efficacy of combining the immunotherapy drug pembrolizumab with an oncolytic virus called T - VEC.

The researchers plan to gather the safety data needed to take the metabolite into clinical testing in humans, a process that Gould cautions could still take years.

The clinical trials will test the safety and efficacy of the procedure.

A clinical trial in the Republic of Korea for patients with degenerative eye diseases is the first to test the safety of an embryonic stem cell therapy for people of Asian descent.

The new method, first developed for automated food safety testing and then adapted by Cornell scientists for a wider range of sample types, can detect the bacteria from environmental and clinical samples, including swabs, feces, milk and blood.

«Our goal is to test this novel agent in patients in order to establish safety and then to proceed quickly to rapid clinical development.

«The first phase of clinical trials are tests of human safety, so this is a promising start,» Alvey said.

If these preclinical studies are successful, the researchers plan to further develop their CAR T cell therapy and test its safety and efficacy for different types of metastatic cancer in upcoming clinical trials.

At Merck Frosst Canada, I have been an integral part of the discovery of a new molecule, the testing of its mechanism of action, the validation of its safety and efficacy in Phase IIb and III clinical trials, the market approval of the resulting product, and the subsequent management of patients and their disease.

It costs millions of dollars to develop drugs and get them tested in animals before they can ever be used in clinical trials for safety and efficacy in humans.

By 2007, the drug had been tested on cells and in a phase I clinical safety trial in healthy volunteers.

The initial clinical trials established the safety of the test for patients.

On a more pragmatic level, the researchers hope to soon be able to translate the findings into clinical trials to test safety and efficacy in people.

The research, part of a phase I clinical trial to test the safety of the treatment, was published as a letter to the editor in The New England Journal of Medicine earlier this week and will be in the September issue of Human Gene Therapy.

If their phase I clinical trial to test the safety and preliminary efficacy of this therapy gains approval, University of Pittsburgh researchers will test the therapy on 10 patients who suffer from chronic ischemic stroke — the most common form, in which clots block blood flow.

Based on formulation characteristics, safety profiles and small - scale immunogenicity testing, the most promising formulations will be selected and documentation prepared to support further clinical development.

Based on proof - of - concept pre-clinical studies indicating robust efficacy and favorable safety profile, the company is now advancing to conduct a clinical trial testing the efficacy of this new treatment.

The HVTN is an international collaboration that conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.

The Walter Reed Army Institute of Research (WRAIR) began vaccinations today in a Phase 1 human clinical trial to test the safety and immunogenicity of the Zika purified inactivated virus (ZPIV) vaccine.

A new paper published in the Journal of Allergy and Clinical Immunology has reported on a multicentre trial to test the safety and clinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlledClinical Immunology has reported on a multicentre trial to test the safety and clinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlledclinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlled asthma.

In this presentation, we discuss data from studies conducted with academic, clinical, and industry collaborators that demonstrates the utility of the system as a more predictive, human - relevant alternative for efficacy and safety testing of new chemical entitites.

Before drugs or treatments can be approved by the FDA, they must be rigorously tested in clinical trials to determine their safety and efficacy.

But, he notes that it will be necessary to perform well - designed clinical trials that test the safety and efficacy of high - grade NMN in humans before making the leap to using NMN (or perhaps its analogs) as pharmacotherapeutic agents.

«We have been very concerned about reports of patients using unproven medical therapies whose safety and efficacy have not been tested in systematic clinical trials,» he said.

«Our next goal is to replicate these experiments and test their safety in larger mammals, such as pigs, before considering clinical trials in humans,» added Dr. Srivastava, who is also a professor at the University of California, San Francisco (UCSF), with which Gladstone is affiliated.

This partnership allows rigorous testing of efficacy, safety and long - term reliability of neurotechnology that would not be otherwise possible within the traditional «silos» of academic, industry, regulatory and clinical communities.

Because the long - term use of VPA in the clinical setting amassed pharmacokinetics and safety data, it is rational to test VPA in allogeneic BMT patients in combination with standard GVHD prophylaxis or treatment.

The objectives to achieve within the 4 years of the NAREB project are: 1 / to select antibacterial molecules and design nanocarriers with strong antibacterial activity, 2 / to test in vitro and in vivo the best therapeutic combinations including innovative genomic and bioimaging approaches, 3 / to assess safety, regulatory and production (GLP / GMP) aspects for the most promising nanoformulations, and 4 / to establishing the Clinical Development Plan for the preparatory work for the subsequent clinical testing of the selected nanoformuClinical Development Plan for the preparatory work for the subsequent clinical testing of the selected nanoformuclinical testing of the selected nanoformulations.

Given that drugs derived from JQ1 are already being tested in cancer clinical trials, their safety and efficacy in humans are already being defined.

Picker explained that clinical trials are gearing up to test the safety and efficacy of a human version of the vaccine.

The researchers said clinical trials are needed to test the safety and effectiveness of this drug and similar compounds.

On Monday, the National Institutes of Health (NIH) announced the launch of the first of five clinical trials in humans to test the safety and effectiveness of a Zika vaccine.

This study was performed specifically to test the aromatase inhibiting ability of 6 OXO, its clinical safety, and to determine its effects on the hormone levels in the body.

Whereas enthusiasm for fasting is increasing, clinical relevance remains low because of insufficient human data, including almost nonexistent controlled trials (21, 33 — 36), few clinical outcomes studies (37, 38), lack of correction for inflated type I error rates from multiple hypothesis tests, and limited safety data (39 — 41).

Additionally, La Roche - Posay products undergo stringent clinical testing to demonstrate efficacy and safety, even on sensitive skin.