Sentences with phrase «clinical trial study results»

Not exact matches

Even the glitteriest of gold - standard clinical trials, for instance, are often undone by a leaden follow - up study that has the nerve to arrive at a different result.

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.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth) on exclusive breastfeeding at 1 month of age and on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.

The clinical trial in humans was based on positive results of a study in mice published in Nature Communications in Sept. 2015.

The researchers were never able to obtain the data from the original clinical trial sponsor and in the end had to painstakingly reconstruct the study results from the information collected at each individual study site.

Based on results of the current study described in a report online June 18 in the journal Cancer Cell, Johns Hopkins researchers say they are planning a phase I clinical trial to test the paclitaxel - fostamatinib combination therapy in patients with recurrent advanced ovarian cancer.

«We are extremely encouraged by the results of this study and hope that this technology will be adapted for patients for testing in clinical trials in the not - too - distant future.»

In an effort to find out, Stephen P. Juraschek, M.D., Ph.D., research and clinical fellow in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 1997.

«The study results elucidate the molecular mechanisms underlying disease progression in multiple sclerosis models, providing a basis for future clinical trials to determine safety and efficacy of these chemical agents in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.

«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.

In a trio of studies to be presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, investigators at Dana - Farber Cancer Institute will present the results of clinical trials showing that new drug combinations can significantly extend the time in which multiple myeloma is kept in check in patients with relapsed or treatment - resistant forms of the disease.

People diagnosed with cancer gained 3.34 million years of life thanks to cancer clinical trials run by SWOG and supported with public funds, according to new study results to be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), the world's largest clinical cancer research clinical trials run by SWOG and supported with public funds, according to new study results to be presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), the world's largest clinical cancer research Clinical Oncology (ASCO), the world's largest clinical cancer research clinical cancer research meeting.

Although we can not determine what the effects of AF267B will be in humans until clinical trials are complete, we are very excited by the results our study has yielded.»

«It was clear from our findings that many people with IBS should have their vitamin D levels tested, and the data suggests that they may benefit from supplementation with vitamin D. «As a result of this exploratory study, we're now able to design and justify a larger and more definitive clinical trial.»

«But as a clinician, if there are randomized data that would allow us to go from a pilot study to a phase 3 clinical trial, and if the results are good, then we would have to come back to Francis Collins, and say, «This needs to be exported to other communities and ramped up.»

The clear result of this clinical study — that the combination reduced strokes, heart attacks and cardiovascular death by practically 25 per cent compared to either drug alone in both patients with stable coronary or peripheral artery disease — caused the clinical trial to be stopped early, after 23 months, in February 2017.

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.

Independent of these preclinical studies, Clementia Pharmaceuticals is currently conducting phase 2 clinical trials in individuals with FOP, based on the 2011 preclinical results published by Pacifici and Iwamoto.

The results of this study were first released in late 2016 at the international Clinical Trials on Alzheimer's Disease meeting in San Diego.

The new six - year study, «Cognitive enhancement therapy for adult autism spectrum disorder: Results of an 18 - month randomized clinical trial,» involved 54 adults and was led by Shaun Eack, Ph.D., M.S.W., Pitt's David E. Epperson Professor of Social Work and Psychiatry, and Nancy Minshew, M.D., Pitt professor of psychiatry and neurology.

The first - of - its - kind study found the dual treatments to be safe and elicit a clinical response in patients, according to new results from a phase I trial to be presented at the AACR Annual Meeting 2015 on April 19.

«This concern has increased in the last few years based on the results of a clinical trial and two observational studies,» he said.

Using simple statistics, without data about published research, Ioannidis argued that the results of large, randomized clinical trials — the gold standard of human research — were likely to be wrong 15 percent of the time and smaller, less rigorous studies are likely to fare even worse.

Yong, a neuroscientist, initially had the idea to test the acne medicine in an animal model since minocycline has many anti-inflammatory properties that he thought could be useful in treating MS. Soon after obtaining successful research results, in studies also supported by the MS Society of Canada and MSSRF, Yong teamed up with Metz who led the transition into a pilot clinical trial, then a Phase 2, and finally the definitive Phase 3 trial.

However, a new study by University of California San Diego School of Medicine researchers suggests that, despite promising results in clinical trials, smoking cessation drugs alone may not be improving the chances of successful quitting among smokers in general.

Geschwind says the «extremely promising results» of the study make the encapsulated drug a good candidate for clinical trials, particularly for patients with pancreatic ductal adenocarcinoma.

Still, Loke adds, «the results seems quite compelling, especially when you consider the background — all the animal studies and clinical trials that show worms can suppress colitis and other autoimmune disorders.»

Results from recent clinical trials and studies in animals suggest that a class of anti-cancer drugs called angiogenesis inhibitors may be able to temporarily reduce interstitial pressure and improve the efficacy of chemotherapy and radiation treatments.

The first, by researchers based in the UK, Europe and USA, examined data from observational studies and clinical trials (an umbrella review) to summarisze health outcomes associated with vitamin D levels, both naturally circulating and as a result of taking supplements.

The results of the HALT - PKD Clinical Trials Network studies will be published online November 15 in two papers in the New England Journal of Medicine to coincide with presentation at the American Society of Nephrology annual meeting.

The results of the mouse, human and lab studies have been so successful that Dr. Bauman has started a larger clinical trial in volunteers previously cured of head and neck cancer.

Our results suggest the need for future studies involving long - term ambulatory cardiac monitoring to better delineate the risk associated with transient vs persistent perioperative AF, as well as randomized clinical trials to determine optimal strategies for antithrombotic therapy in patients with perioperative AF and a significant burden of other risk factors for stroke,» the authors write.

«These results enable us to determine whether potential treatments will be effective against patients» symptoms by testing them first in healthy volunteers and defining the best doses based on objective physiological data before conducting costly clinical trials,» said Jeffrey Lieberman, MD, the Lawrence C. Kolb Professor and Chairman of the Department of Psychiatry at CUMC, and Principal Investigator of this study.

Porter points out that tPA was not included in the clinical trial because a good result was seen with ultrasound / microbubbles alone in the pig study.

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.

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.

Based on results from this and previous studies, pemetrexed and gemcitabine were included in a St. Jude - led multicenter clinical trial of children and adolescents newly diagnosed with medulloblastoma.

He said the new study demonstrates the power of liquid biopsies of resistant cancers to identify the biological causes and — in the present case — report those mechanisms simultaneously with the publication of the clinical trial results for a new drug.

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

Kenneth Ataga, MD, director of the UNC Comprehensive Sickle Cell Program, was featured in a video by the American Society of Hematology in which he discussed the favorable results of a yearlong clinical trial studying crizanlizumab as a therapy to prevent and treat painful crisis events in patients with sickle cell disease.

These results could offer a valuable tool to study new HD therapeutics entering clinical trials.

Additional limitations to the traditional approach include: costly failures to replicate positive results in larger trials; difficulty in determining the reasons for negative results; low yield in terms of identifying disease or intervention mechanisms due to an exclusive focus on symptom change and clinical endpoints; and, the expensive and very lengthy practice of first establishing multi-component psychosocial treatments followed by years of «unpacking» studies.

The results of long - term safety studies in mice were previously submitted to the Food and Drug Administration to gain permission for a Phase 1 clinical trial under an Investigational New Drug (IND) application.

Based on our findings, the occurrence of cancer is much higher in adults over 75 years of age compared with the proportion of patients in this age group who enroll in clinical trials,» said lead study author Bindu Kanapuru, MD, medical officer in the Division of Hematology Products, Office of Hematology and Oncology Products in the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, who presented the results at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 9 — 12 in Atlanta.

Table 1: Selection, Design & Construction of HSV - based Oncolytic Viruses Table 2: Selection, Design & Construction of Adenovirus - based Oncolytic Viruses Table 3: Selection, Design & Construction of Vaccinia Virus - based Oncolytic Viruses Table 4: Selection, Design & Construction of Vesicular Stomatitis Virus - based Oncolytic Viruses Table 5: Selection, Design & Construction of Newcastle Disease Virus - based Oncolytic Viruses Table 6: Selection, Design & Construction of Various Virus - based Oncolytic Viruses Table 7: Current Company - Sponsored Clinical Trials of T - Vec Table 8: Clinical Trials of ColoAd1 Table 9: Clinical Trials with JX - 594 Table 10: Clinical Trials with GL - ONC1 Table 11: Clinical Trials of CAVATAK (CVA21) Table 12: Clinical Trials with MV - NIS Table 13: Overview of Oncolytic Viruses by Development Phase & Virus Family Table 14: Profile of Approved and Marketed Oncolytic Viruses Table 15: Pivotal Study Design of Oncolytic Viruses in Late Stage Development Based on Previous Clinical Results Table 16: Approved Indications of Immune Checkpoint Inhibitors Table 17: Active Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 18: Planned Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 19: Active or Planned Clinical Studies of Oncolytic Viruses in Combination with Other Anti-Cancer Therapeutics Table 20: Pattern of Transgenes in Oncolytic Viruses in Relation to Development Phase Tables 21a and 21b: Indications and Frquency and Way of Administration of Oncolytic Viruses in Active and / or Positive Completed Clinical Studies Table 22: Small and Medium Pharma & Biotech as Partner for Regional Co-Development of Oncolytic Viruses Table 23: Immuno - Oncology Portfolio of Major Pharma & Biotech with Interest in Oncolytic Viruses Table 24: Interests of Major Pharma & Biotech in Oncolytic Viruses Table 25: First Generation Oncology Virus Companies and their Sources of Technology Table 26: Second Generation Oncology Virus Companies and their Sources of Technology Table 27: Third Generation Oncology Virus Companies and their Sources of Technology Table 28: Fourth Generation Oncology Virus Companies and their Sources of Technology Table 29: Grants, Credits & Donations Table 30: Financing by Venture Capital, Private Equity and Other Private Placements Table 31: Collaboration & Licensing Agreements Table 32: Companies Listed on Stock Exchange & Offerings Table 33: Mergers & Acquisitions

A malaria vaccine has shown promising results in early stage clinical trials, a study suggests.

Results of 2 cellular immunotherapy trials I'd like to bring your attention to two recently published clinical studies in cancer cellular immunotherapy field.

Cell therapy has been studied for multiple degenerative disorders and promising results from preclinical studies and clinical trials have been described for some.

Since beta - CDs are currently being tested in humans for the treatment of genetic forms of cholesterol accumulation (e.g. Nieman - Pick disease), a successful result in this study might mean that the drug combination could then be accelerated for testing in clinical trials for AMD.