Sentences with phrase «phase i trials without»

And it launched its first two phase I trials without announcing what diseases they targeted — a decision Bancel attributes to fears that financial markets would prematurely pigeonhole the company into a particular field.

Not exact matches

In a pilot study that included children at high risk for type 1 diabetes, daily high - dose oral insulin, compared with placebo, resulted in an immune response to insulin without hypoglycemia, findings that support the need for a phase 3 trial to determine whether oral insulin can prevent islet autoimmunity and diabetes in high - risk children, according to a study in the April 21 issue of JAMA, a theme issue on child health.

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.

The plan is to predict very early which drugs are likely to succeed and which are not, and promote the winners rapidly to larger (phase III) trials, which most likely would be run by private companies, without data sharing.

«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 Medtrials 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 MedTrials and Dean for Genetic and Genomic Medicine, Icahn School of Medicine.

Patients with advanced NSCLC with the EGFR mutation, with or without the T790M resistance mutation, were enrolled in the phase I / II clinical trial in centres in Europe, Australia and the USA; enrolment of patients for the phase I part of the study began in March 2012, and for the phase II part in August 2013.

1999 — Wilson publishes phase I trial results showing it is almost impossible to get the CFTR gene into CF patients» lung cells without immune rejection.

However, in this Phase II clinical trial, designed to prospectively evaluate the safety and effectiveness of ACHT for patients with HIV - related lymphoma, researchers discovered that this population had no greater likelihood of developing these complications compared to those without the virus.

A randoMized phAse II trIal of fulvestraNt wiTh or without Ribociclib After progression on AntI-estrogeN therapy plus cyclin - dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer (MAINTAIN TtrIal of fulvestraNt wiTh or without Ribociclib After progression on AntI-estrogeN therapy plus cyclin - dependent kinase 4/6 inhibition in patients with unresectable or metastatic hormone receptor positive, HER2 negative breast cancer (MAINTAIN TrialTrial)

A Phase III Randomized Trial of Chemotherapy with or without Bevacizumab in Patients with Recurrent or Metastatic Head and Neck Cancer

A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for Patients with Completely Resected Stage IB (> or = 4 cm)- IIIA Non-Small Cell Lung Cancer (NSCLC)

To ensure engraftment without severe GVHD, O'Donnell has conducted Phase I / II clinical trials since 1999 in which a half - matched transplant is performed and then a high dose of chemotherapy is administered to the patient three days later.

A small, phase 1 trial, published early online in the journal Radiology, found that this approach, designed to treat just the diseased portion of the prostate rather than removing or irradiating the entire gland, is safe and can be performed without the troubling complications associated with more aggressive therapies.

In their first - in - human, double - blind, placebo - controlled Phase I trial, Prothena scientists recruited 40 healthy people without PD to receive either placebo injections or or one of 5 doses of PRX002, ranging from 1 to 30 mg / kg.

The following details come from 4Gamer, translated by DualShockers... - SMT producer Kazuyuki Yamai explains that this is the first time on a long time that a numbered Shin Megami Tensei game gets released on home consoles - he aims to develop it properly, without making any compromise - details are being filled up, art is being created - the process is in the «scrap and build» phase, iterating the gameplay on the actual console - team is in a phase of iteration and trial and error.

During the discovery and pre-trial phase, there is often an opportunity to settle the case without trial as the facts are developed through discovery and the law is developed through motions.