Sentences with phrase «from phase iii»

IGNORE THESE FINDINGS AT YOUR PERIL: Project RED Announces Significant Results from Phase III Research

Email in your podcast questions: [email protected] Could Marvel pulling Inhumans from their Phase III slate actually mean 20th Century Fox have agreed a deal to include the X-Men in the MCU from Phase IV onwards?

The drug was approved based on efficacy and safety results from a phase III trial presented earlier this year at the 2015 American Society of Clinical Oncology Annual Meeting.

Findings from a phase III clinical trial of about 300 women may introduce PARP inhibitors as a new type of treatment for breast cancer

Results from a phase III trial with another antibody that targets β amyloid — solanezumab, developed by Eli Lilly — should be announced later this year.

Only 10 (23 %) of these additional recommendations were based on evidence from randomised controlled trials, and seven (16 %) were based on evidence from phase III studies.

The latest findings from a Phase III clinical trial in thousands of African children appear today in the New England Journal of Medicine.

We look forward to the results from the phase III trial with interest.»

The full data from the Phase III study, dubbed ATHOS - 3, of Angiotensin for treating catecholamine - resistant hypotension, or CRH, was published in the New England Journal of Medicine.

The Study And The Results The full data from the Phase III study,...

Not exact matches

Yu, from Guangzhou, put down a deposit on a 1.2 million yuan, 59 - square - meter apartment in Phase III of the project while visiting the vast landscaped sales gallery at the construction site in December.

Moreover, he then realized that his entire discussion of the phases of concrescence in part III is inappropriate to God, since God does not initiate his concrescence from his physical pole.

The phase III study was conducted among 366 patients with TSC and epilepsy from 25 countries who were randomly assigned to either a placebo, a low dose of everolimus or a higher dose.

A retrospective analysis of those who participated in phase III trials in 2011 found that those who had never had a dengue infection at the time of vaccination were in rare cases at risk of enhanced disease, although the Dengvaxia vaccine did reduce infections and cases of serious illness in those who had previously suffered from dengue.

NRG Oncology / RTOG 0232 is a phase III, multi-institutional trial conducted at 68 cancer centers throughout the U.S. and Canada from 2003 to 2012 to assess whether adding EBT to transperineal interstitial permanent brachytherapy conveyed an additional benefit in progression free survival (PFS), or control of the cancer growth, at five years following treatment.

He says results from phase II and III trials on these new therapies designed to stall the disease are slated to come out within the year.

The HYPO - RT - PC trial, a randomized multi-institutional phase III trial in Scandinavia, was designed to assess outcomes from highly accelerated extreme hypofractionation, which is delivered in smaller number of high doses — seven fractions of 6.1 Gy each in this study.

In 2011, Science's editors will be watching a smaller detector at the Large Hadron Collider called LHCb, which will study B mesons in great detail; new techniques that should lead to the discovery of many more genes contributing to adaptation; an ignited fusion burn at the National Ignition Facility; broadly neutralizing antibodies, which are capable of disabling a wide range of viral variants; the first plug - in hybrid electric cars whose batteries are charged from a wall socket go on the market; and the results of the first phase III trial of a malaria vaccine.

A randomized phase III trial finding that a new monoclonal antibody, elotuzumab, added to standard therapy, extended the duration of remission for patients with relapsed multiple myeloma by about five months Findings from two phase III studies showing that children with Wilms tumor who have a specific chromosomal abnormality do better with a more intensive, augmented chemotherapy regimen

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

TRINOVA - 1 was a randomized prospective phase III clinical trial that added trebananib or placebo to standard chemotherapy (weekly paclitaxel) among 919 women with recurrent ovarian cancer patient from 179 sites in 32 countries.

An affordable hepatitis C combination treatment including the new drug candidate ravidasvir has been shown to be safe and effective, with extremely high cure rates for patients, including hard - to - treat cases, according to interim results from the Phase II / III STORM - C - 1 trial presented by the non-profit research and development organisation Drugs for Neglected Diseases initiative (DNDi) at the International Liver Conference in Paris.

Results from three Phase III clinical trials (ION - 1, ION - 2 and ION - 3) evaluating the investigational once - daily fixed - dose combination of the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and the NS5A inhibitor ledipasvir (LDV) 90 mg, with and without ribavirin (RBV), for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection have been presented at the International Liver CongressTM 2014.

A drug used to treat men with late - stage prostate cancer proved effective in stemming progression of the disease in research participants who had not yet received chemotherapy and extended their survival, according to results from a multi-national Phase III clinical trial led by the Knight Cancer Institute at Oregon Health & Science University (OHSU).

The results of the Phase II trial now have to be verified in a (multi-centre) clinical Phase III trial — as soon as this trial has been successfully completed and a partner has been found from the pharmaceutical industry, this immunotherapy could be available in a few years for treating apple allergy.

They have the opportunity to be exposed to a wide variety of clinical and patient - oriented research, from Phase I, II, and III trials to collection of samples and clinical data used to identify genetic variation that leads to human disease.

«The data from these two Phase III trials conducted in Europe and in the U.S. support the effectiveness of this novel photo - protective drug, offering the patients in Europe — where the drug has been approved by the European Medicines Agency — the opportunity to perform their daily functions without the pain induced by sun exposure,» said Robert J. Desnick, PhD, MD, Principal Investigator of the U.S. Trials and Dean for Genetic and Genomic Medicine, Icahn School of Medicine.

Despite encouraging evidence from animal studies that it clears amyloid from the brain, when it came to clinical improvements in human patients the drug proved no better than placebo in two phase III clinical trials.

While the last decade has seen many potential new agents for hepatocellular carcinoma fail in clinical trials, phase I and II data from early regorafenib trials were promising, and led to the initiation of this international, multi-center phase III trial.

Although just published in The Lancet, those findings have since been overtaken by strikingly positive results from the larger phase III trials.

«To evaluate these findings in a group with only one HER2 treatment, we are currently analyzing data from another clinical trial, the GeparQuinto clinical trial, which is a randomized, phase III clinical trial evaluating two different neoadjuvant therapy regimens with a single anti-HER2 treatment [trastuzumab or lapatinib] for women with HER2 - positive breast cancer,» said Loibl.

Dr James Larkin, a Consultant Medical Oncologist at The Royal Marsden, London, UK, told the 2015 European Cancer Congress [1], that results from the CheckMate 067 phase III clinical trial had already shown that the combination of the two drugs, which target two different pathways that regulate the immune system, improved the progression - free survival in patients with melanoma who had not received any other treatment.

Related research (Pereira HJ, et al., 2012) used two different lines of evidence to explain the increase in the ratio of anteiso — to iso - branched alkenes that was observed during the transition from early to late stationary phase in M. luteus: structural studies of a key enzyme involved in fatty acid biosynthesis in M. luteus (FabH, or ß - ketoacyl - ACP synthase III) and transcriptional (whole - genome microarray) studies of M. luteus during different growth phases.

Phase III trials involve thousands of participants and occur only after the experimental vaccine has successfully moved from a Phase I and Phase II trial.

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.

GenIbet's core activity is the manufacture and supply of materials for use in early stage drug development, pre-clinical studies and cGMP manufacturing from Phase I to Phase III clinical trials.

According to Col Jerome Kim, Walter Reed Army Institute of Research, US, who was also part of the lead group for the study, apart from the current four doses of vaccines that were given to subjects in the phase III clinical trials in Thailand, they are planning to give a booster does after six months to increase the strength of the vaccine.

This approval will also allow ReNeuron to expand its ophthalmology program; it plans to soon apply to increase its Phase I / II trial on RP from six to 20 patients with a view to progress to a Phase II / III on delivery of positive data.

Information from volunteers who have received this vaccine in African countries will be of particular interest in light of the announcement that Phase III studies will begin in Guinea this week.

It was very satisfying to realise that many people could already benefit from these clinical trials within 1 - 3 years, and even more people in the future if these drugs make it through Phase III trials.

The randomized phase III study included 180 patients aged 0 to 18 years with hematologic malignancies who underwent transplant from an unrelated donor selected using high - resolution typing for HLA - class I / II loci.

Paris, France, April 3, 2018, 5.35 pm CET — GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA - PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced topline results from the REVERSE Phase III clinical trial evaluating the safety and efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in 37 subjects whose visual loss due to 11778 - ND4 Leber Hereditary Optic Neuropathy (LHON) commenced between 6 and 12 months prior to study treatment.

ViaCyte, Inc. (CA, USA) has received a Small Business Innovative Research Phase III award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK; MD, USA) to further the development of stem cell - derived functional human beta cells in vitro.

[ii] Pooled Analysis of Long - Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma.

GenSight Biologics announces topline results from REVERSE Phase III clinical trial of GS010 in patients with Leber Hereditary Optic Neuropathy (LHON)

Near - IR reflectance spectroscopy of 433 Eros from the NIS instrument on the NEAR mission: I. Low phase angle observations J. F. Bell III, N. I. Izenberg, P. G. Lucey, B. E. Clark, C. Peterson, M. J. Gaffey, J. Joseph, B. Carcich, A. Harch, M. E. Bell, J. Warren, P. D. Martin, L. A. McFadden, D. Wellnitz, S. Murchie, M. Winter, J. Veverka, P. Thomas, M. S. Robinson, M. Malin, and A. Cheng Icarus 155, 119 — 144, doi: 10.1006 / icar.2001.6752, January 2002.

However, subset analyses of phase III trials suggest that patients with EGFR mutation - positive NSCLCs do not benefit from immunotherapy compared with docetaxel.

In his role as IDRI's Chief Medical Officer, Corey is developing and leading all clinical trial programs for IDRI from preclinical to Phase III, including oversight and management of data functions.

Low - Dose ATLG Prevents GVHD in Pediatric Hematologic Malignancies: A newly published randomized phase III study of pediatric patients showed lower doses of rabbit anti — T - lymphocyte globulin (ATLG) was superior to a higher dose in children with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation from an unrelated donor.

A phase III study of TTFields following Stereotactic Radiosurgery for 1 - 10 Brain Metastases from Non-Small-Cell Lung Cancer more...