Sentences with phrase «phase of clinical trials for»

The second phase of clinical trials for a new vaccine is complete and the results are very promising.

There is no vaccine yet, but the National Institutes of Health has entered the first phase of clinical trials for an investigational vaccine.

Not exact matches

March 30, 2017 — Aura Biosciences Announces Initiation of Phase 1b Clinical Trial and Receipt of FDA Fast Track Designation for AU - 011 for the Treatment of Primary Ocular Melanoma

Cambridge, MA — March 30, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it has enrolled and dosed the first patient in its Phase 1b clinical trial of light - activated AU - 011, an investigational, first - in - class targeted therapy in development for the treatment of ocular melanoma, a rare and life - threatening disease.

For the second time in 5 months, Juno Therapeutics has put a clinical hold on a Phase II trial of JCAR015 in adult patients with relapsed or refractory B - cell acute lymphoblastic leukemia due to patient deaths.

Juno Therapeutics is seeking to change the protocol for the Phase II ROCKET clinical trial of its acute lymphoblastic leukemia candidate JCAR015, which the FDA has placed on clinical hold following the deaths of three patients, two of them last week.

Most biotechs would have shuttered a clinical program that showed absolutely no efficacy whatsoever in a late - stage trial, but Novavax has instead doubled down on RSV by going forth with its phase 3 trial of the RSV F vaccine for infants via maternal immunization, and begun planning for another trial in older adults that's reportedly on track to kick off in 2018.

A phase I clinical trial for a Zika vaccine which began in August 2016 in partnership with the Wistar Institute and Inovio / GeneOne Pharmaceuticals aims to discover the safety and effectiveness of a DNA vaccine for Zika.

«There are currently no therapies which successfully reverse the damage seen in the more than 12,000 individuals who suffer a spinal cord injury each year in the United States alone,» says Dr. Richard G. Fessler, professor of neurological surgery at Rush University Medical Center and principal investigator for the Phase 1 clinical trial involving AST - OPC1 (oligodendrocyte progenitor cells).

The phase 1 clinical trial is the first to test the functional replacement of the mutated gene responsible for SMA1.

The Phase I clinical trial of OMP - 54F28 (FZD8 - Fc) is an open - label dose escalation study in patients with advanced solid tumors for which there was no remaining standard curative therapy.

«The results of the phase III clinical trial show that a target fusion biopsy detects more clinically significant prostate cancer,» said Art Rastinehad, DO, principal investigator of the study and director of interventonal urologic oncology at North Shore - LIJ's Arthur Smith Institute for Urology, in New Hyde Park, NY.

But highly trained life scientists will still be needed for such tasks as late - stage development (ensuring smooth implementation of final phase (III and IV) clinical trials) as well as compliance with regulatory demands (so - called commissioning and validation specialists), according to Croonen.

Gault transferred to a new research area — Alzheimer's disease — where she is now responsible for several proof - of - concept trials, also known as phase II clinical trials.

Watercress extract taken multiple times a day significantly inhibits the activation of a tobacco - derived carcinogen in cigarette smokers, researchers at the University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCenter, demonstrated in a phase II clinical trial presented today at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans.

Last month, Biopure launched a revamped clinical development program, emphasizing testing in Europe, with three phase II clinical trials planned for 2008 to study the impact of its product on heart attack patients, chemotherapy patients with anemia and the terminally ill.

Northfield Laboratories, Inc., in Evanston, Ill., has been conducting clinical trials for its oxygen - carrying red blood cell substitute, PolyHeme, but in May said the product failed to meet the primary goals of mortality and safety in an important phase III study.

A phase III clinical trial in hundreds of people must be performed before the treatment could be recommended for smokers, and Dr. Yuan warned that while eating cruciferous vegetables, such as watercress and broccoli, is good for people, they are unlikely to have the same pronounced effect as the extract.

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.

It showed effectiveness against liver cancer in a phase II clinical trial and will move into a phase III trial later this year, David Kirn, an oncologist and the company's president and chief executive officer, said at a recent meeting of the American Society for Gene & Cell Therapy in Washington, D.C..

Phase I / II clinical trial results reported at the American Society for Clinical Oncology (ASCO) Annual Meeting 2015 show promising results for investigational drug brigatinib against ALK + non-small cell lung cancer (NSCLC), with 58 of 78 ALK + patients responding to treatment, including 50 of 70 patients who had progressed after previous treatment with crizotinib, the first licensed ALK inclinical trial results reported at the American Society for Clinical Oncology (ASCO) Annual Meeting 2015 show promising results for investigational drug brigatinib against ALK + non-small cell lung cancer (NSCLC), with 58 of 78 ALK + patients responding to treatment, including 50 of 70 patients who had progressed after previous treatment with crizotinib, the first licensed ALK inClinical Oncology (ASCO) Annual Meeting 2015 show promising results for investigational drug brigatinib against ALK + non-small cell lung cancer (NSCLC), with 58 of 78 ALK + patients responding to treatment, including 50 of 70 patients who had progressed after previous treatment with crizotinib, the first licensed ALK inhibitor.

Combining radiation therapy with chemotherapy for patients with limited metastatic non-small cell lung cancer (NSCLC) may curb disease progression dramatically when compared to NSCLC patients who only receive chemotherapy, according to a new randomized phase II clinical trial reported today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

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.

Since CGP3466B has already been tested in phase II clinical trials to (unsuccessfully) treat Parkinson's disease and ALS, it is known to be safe for humans, but the researchers caution that many more years of studies are needed to definitively show whether it is effective for preventing cocaine damage, first in mice, then in humans.

In the Phase II clinical trial, Dr. Miller and colleagues in the National Cancer Institute - supported Gynecologic Oncology Group found that in patients who had not received prior chemotherapy, the combination cocktail had a 31 percent response rate for up to 7 months, and an overall survival of 12 months.

Trial # 6: Phase I clinical trial and pharmacodynamic evaluation of combination HCQ and doxorubicin treatment in pet dogs treated for spontaneously occurring lymTrial # 6: Phase I clinical trial and pharmacodynamic evaluation of combination HCQ and doxorubicin treatment in pet dogs treated for spontaneously occurring lymtrial and pharmacodynamic evaluation of combination HCQ and doxorubicin treatment in pet dogs treated for spontaneously occurring lymphoma

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.

«Since several BACE1 inhibitors are currently being evaluated in clinical phase 3 trials for the treatment of Alzheimer's disease, the identification of potential side effects will be of great importance to ensure a positive clinical outcome,» said Dr. Jochen Herms, a Professor of translational brain research at Ludwig - Maximilians - University Munich.

P: We found discodermolide [a drug from Discodermia, a sponge found in the Caribbean, the Bahamas, and the Gulf of Mexico], and it's gone through phase I clinical trials for treatment of solid tumors such as ovarian, pancreatic, breast, colon, or lung cancers.

«First - line immunotherapy treatment can improve survival for subset of lung cancer patients: Results of phase III global clinical trial show that 75 percent of stage IV lung cancer patients with both complex tumor mutations and PDL - 1 positive status respond to nivolumab.»

When Theravance, the company in South San Francisco, California, that developed the drug, designed the large phase III clinical trials needed for approval, the FDA simply required a demonstration that the drug eliminated symptoms of infection as reliably as the approved antibiotic vancomycin.

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.

Her research at Stanford University has contributed to the development of a small molecule peptide that is currently in Phase IIA clinical trials for AD.

Working for a CRO will expose recruits to many different phases of clinical trials in diverse therapeutic areas.

For this reason, a CRO is a great place for new recruits to get exposure to clinical trials at different phases and across a variety of therapeutic areFor this reason, a CRO is a great place for new recruits to get exposure to clinical trials at different phases and across a variety of therapeutic arefor new recruits to get exposure to clinical trials at different phases and across a variety of therapeutic areas.

Watterson and his collaborators have a new National Institutes of Health (NIH) award to further refine the compound so it is metabolically stable and safe for use in humans and develop it to the point of starting a phase 1 clinical trial.

This compound has been recently designated for phase III clinical trials to test its efficacy for treating epilepsy and providing relief of neuropathic pain.

Two new phase III clinical trials investigating the efficacy and safety of bitopertin, a glycine uptake inhibitor considered to be a promising new add - on therapy for treating negative symptoms in schizophrenia, failed to show a benefit of the drug over placebo.

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.

Based on the results of this trial and past work, Ory said a larger phase three clinical trial — that is both randomized and controlled — is already underway investigating cyclodextrin for patients with NPC.

In a small phase I and II clinical trial, Johns Hopkins researchers and colleagues elsewhere found that the high - fat, low - carbohydrate ketogenic diet was a safe and effective treatment option for the majority of adults experiencing a relatively rare, often fatal and always severe form of epilepsy marked by prolonged seizures that require medically induced comas to prevent them from further damaging the body and the brain.

The safety study sets the stage for phase II clinical trials looking at whether high dose vitamin C is effective at extending overall lifespan and quality of life for patients undergoing radiation and chemotherapy.

«This study presents a novel strategy for treating multiple myeloma, and we hope to bring it to patients as part of a phase I clinical trial as soon as possible,» Hofmeister says.

Hence, a total of 90 patients from nine centers were randomly assigned to one of two study arms for the phase II clinical trial: the first taking capsules of olaparib (400 mg twice daily) and the other taking a combination of the two drugs (200 mg olaparib in capsule - form twice daily and 30 mg tablets of cediranib once daily).

A study presented at the 50th Annual Meeting of the American Society for Clinical Oncology (ASCO) describes the results of a phase I clinical trial of the investigational agent DMOT4039A against pancreatic and ovarian Clinical Oncology (ASCO) describes the results of a phase I clinical trial of the investigational agent DMOT4039A against pancreatic and ovarian clinical trial of the investigational agent DMOT4039A against pancreatic and ovarian cancers.

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.

Vertex has already developed a drug cocktail for patients with the most common CF mutation — responsible for the overwhelming majority of cases — with phase III clinical trials underway.

Should the results of this study be repeated in the larger Phase III trial, it would lead to a new standard of care for kidney cancer patients, said Dr. Hammers, formerly of Johns Hopkins medical system, who holds the Eugene P. Frenkel, M.D. Scholar in Clinical Medicine at UT Southwestern.

Researchers at Massachusetts Eye and Ear / Harvard Medical School and the University of Crete have conducted a phase I / II clinical trial investigating the efficacy of statins (cholesterol - lowering medications) for the treatment of patients with the dry form of age - related macular degeneration (AMD)-- the leading cause of blindness in the developed world.

The results of two phase 3 clinical trials that led to FDA approval of adalimumab for treatment of the chronic inflammatory skin disease hidradenitis suppurtiva (HS) are being published in the August 4 New England Journal of Medicine.