Sentences with phrase «therapy trials at»

This idea is an extension of Dr. Alexey Bersenev's tracking of Cell Therapy Trials at his Hematopoiesis Blog.

Philadelphia — Ten years ago this month the promise of using normal genes to cure hereditary defects crashed and burned, as Jesse Gelsinger, an 18 - year - old from Tucson, Ariz., succumbed to multiorgan failure during a gene therapy trial at the University of Pennsylvania.

Gene therapy experts are heartened by the new results, which may counteract a wave of negative publicity after the death last year of a volunteer in a gene therapy trial at the University of Pennsylvania (ScienceNOW, 9 December 1999).

Not exact matches

Both startups are planning clinical trials to test whether their therapies are better than current antibiotics at defeating bacteria.

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).

REINVENTING THE CLINICAL TRIAL Research Track Traditional clinical trials ask one question: Does an experimental treatment work better than nothing at all — or, the very least, the standard therapy offered patients.

«There's more emphasis now and there will be more emphasis because of the Affordable Care Act [on] offering mental health services in primary care settings,» suggests Curry, who is about to start a clinical trial looking at the effects of cognitive behavior therapy for adolescents with depression and substance abuse problems.

Private Midwifery at Queen Charlotte's & Chelsea Hospital, London, who is putting together a clinical trial looking at how alternative therapies can help women giving birth.

Written on October 30, 2013 at 12:20 pm Categories: Home Blogroll, Thirsties Therapy Help Tags: by Sonya, cloth diaper trial programs, cloth diapers

Adding abiraterone to hormone therapy at the start of treatment for prostate cancer improves survival by 37 per cent, according to the results of one of the largest ever clinical trials for prostate cancer presented at the 2017 ASCO Annual Meeting in Chicago and published in the New England Journal of Medicine.

«My team at Nationwide Children's has worked with commitment and dedication to develop a therapy that may subsequently be shown through future clinical trials to potentially alter the course of this unforgiving condition and provide a therapeutic option for the families and infants with SMA1,» says Jerry Mendell, MD, principal investigator in the Center for Gene Therapy at Nationwide Chiltherapy that may subsequently be shown through future clinical trials to potentially alter the course of this unforgiving condition and provide a therapeutic option for the families and infants with SMA1,» says Jerry Mendell, MD, principal investigator in the Center for Gene Therapy at Nationwide ChilTherapy at Nationwide Children's.

A two - year trial has found that long - acting injections of antiretroviral therapy work just as well or better at controlling HIV than daily pills

Several large trials of amyloid - based therapies are underway in groups of people more carefully selected to be at high risk for Alzheimer's.

«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).

This was caused by an erroneous and incomplete search by the manufacturer for studies on the comparator therapy; no search at all was conducted in trial registries.

Using data from a randomized trial of 206 men treated with either radiation or, radiation and six months of hormonal therapy, researchers compared early markers of prostate cancer death to identify men at risk of dying early.

At Amgen, the drug made it all the way to a phase III clinical trial before the company pulled the plug partway through the trial after concluding that the therapy was unlikely to help patients live longer.

He notes his company had planned this year to apply to the U.S. Food and Drug Administration to use red blood cells and platelets derived from iPS cells in clinical trials, but «at this point, therapies with these cells are years off.»

Three trials are now open for OMP - 54F28 (FZD8 - Fc) in combinations with standard therapy for pancreatic, ovarian and liver cancers, being offered at the CU Cancer Center and elsewhere.

«These are optimistic results for one of the first targeted therapies for cancer stem cells,» says Antonio Jimeno, MD, PhD, investigator at the CU Cancer Center, director of the university's Cancer Stem Cell - Directed Clinical Trials Program, and principal investigator of the clinical trial at the CU Cancer Center site.

At the moment there are no therapies for humans and animals, but many new variants of immunotherapy have entered trial phase.

Monica Bertagnolli, chief of the Division of Surgical Oncology at Brigham and Women's Hospital and chair of the Alliance for Clinical Trials in Oncology, a nationwide effort to test new therapies, says she was thrilled that the president used the word «cure» in his speech at all.

«I think [there's] a lot more of an understanding about what's feasible, what's safe, what's ethical,» says Anna David, who studies fetal therapy at University College London and is collaborating with Semler on the OI trial.

Advanced clinical trials are underway for at least 10 investigational therapies that have shown promise in slowing or blocking development of Alzheimer's disease.

He was catching potential investors at an inauspicious time: Many were smarting from disappointing trials of RNA interference therapies, which use short, double - stranded RNA to disrupt the production of disease - causing proteins.

This vaccine has been at the heart of a controversy in the US after Congress awarded the defence department $ 20 million to test it in large - scale trials in America as an immune therapy for HIV - positive people.

Antiretroviral therapy (ART) for HIV infection provides lasting protection against the sexual transmission of the virus from infected men and women to their HIV - uninfected sexual partners, investigators from the HIV Prevention Trials Network (HPTN) reported today at the 8th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, Canada.

Research groups at universities and hospitals need to meet strict safety guidelines for clinical trials but some small private clinics are offering therapies to people without research or marketing approval.

The case shows that even when carried out at mainstream hospitals, experimental stem cell therapies can have unpredictable consequences, says Alexey Bersenev, a stem cell research analyst who blogs at Cell Trials.

Jennifer A. Woyach, M.D., of Ohio State University, Columbus, and coauthors described the characteristics of patients who discontinued ibrutinib therapy and their outcomes in a group of 308 patients participating in four trials at a single institution.

Ipilimumab as adjuvant therapy significantly improves overall survival in patients with high risk stage III melanoma, according to the EORTC 18071 phase III trial results presented for the first time at the ESMO 2016 Congress in Copenhagen.

Sean Morrison, Professor and Director of the Children's Medical Center Research Institute at UT Southwestern Medical Center in the United States, who is not an author on the paper, added: «Patients are ultimately not helped by therapies that are not based on sound science and that are not tested in systematic clinical trials.

«Our gene therapy protocol is not yet ready for clinical trials — we need to tweak it a bit more — but in the not - too - distant future we think it could be developed for therapeutic use in humans,» says Jeffrey Holt, PhD, a scientist in the Department of Otolaryngology and F.M. Kirby Neurobiology Center at Boston Children's and an associate professor of Otolaryngology at Harvard Medical School.

In our trial, however, the addition of radiation therapy directed at each of the cancerous areas greatly improved how patients responded to subsequent rounds of chemotherapy,» said Puneeth Iyengar, MD, PhD, lead author of the study and an assistant professor of radiation oncology at the University of Texas Southwestern Medical Center in Dallas.

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..

Ultimately, Holt hopes to partner with clinicians at Boston Children's Department of Otolaryngology and elsewhere to start clinical trials of TMC1 gene therapy within 5 to 10 years.

Clinical trials that charge enrollees to participate are ostensibly aimed at giving patients early access to promising therapies — often in the fields of stem cells or aging reversal — that are too unusual or have too little profit potential to get funding from traditional sources such as companies, foundations, or the National Institutes of Health.

The «new therapy, we believe, is a standard of care in terms of the benefits,» said N. Scott Adzick of CHOP, a pediatric surgeon who heads the fetal surgery program there and leader of the trial, at a press conference.

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).

Trials of the vaccine therapy are planned to start later this year at Massachusetts General Hospital in Boston, Johns Hopkins Medical Center in Baltimore, the Queensland Institute of Medical Research (QIMR) in Brisbane and the Royal Netherlands Cancer Institute in Amsterdam.

These results are especially remarkable given that Cannata was participating in a Phase I safety trial that delivered the therapy at a relatively low dose.

Some on the panel suggested they were particularly sensitive about such concerns given that it was at UPenn in 1999 that a young man, Jessie Gelsinger, died in a gene therapy trial, setting the field back for years.

The phase I and phase I / II trials aimed to measure the safety of adding HCQ to either chemotherapy, radiation therapy or targeted therapies, its effectiveness at inhibiting autophagy, and the potential clinical benefit of HCQ combination therapies.

Presenting these results at the 3rd ESTRO Forum in Barcelona, Spain, today (Monday) Professor James Morris, from the Department of Radiation Oncology, Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA), Vancouver, Canada, will say that the ASCENDE - RT1 trial is the first and only existing trial comparing low - dose - rate prostate brachytherapy (LDR - PB) for the curative treatment of prostate cancer with any other method of radiation therapy delivery.

Researchers in US and Canada funded by the Cooperative Studies Program of the Department of Veterans Affairs and the Canadian Institutes for Health Research compared the costs and benefits of etanercept - methotrexate first versus triple therapy first in 353 patients enrolled in the RACAT trial who continued to have uncontrolled symptoms of RA after at least 12 weeks of methotrexate therapy.

The proposed clinical trial, in which researchers would use CRISPR to engineer immune cells to fight cancer, won approval from the Recombinant DNA Advisory Committee (RAC) at the U.S. National Institutes of Health, a panel that has traditionally vetted the safety and ethics of gene therapy trials funded by the U.S. government and others.

The study demonstrated that a group of trial participants with low 21 - gene recurrence score (Oncotype DX ® Recurrence Score ®) results of 10 or less who received hormonal therapy alone without chemotherapy had less than a one percent chance of distant recurrence at five years.

After seeing promising results in phase 1 of the Pediatric Leukemia Adoptive Therapy (PLAT - 02) trial with 93 percent of patients with relapsed or refractory acute lymphoblastic leukemia (ALL) achieving complete initial remission, researchers at Seattle Children's are continuing their quest to improve the experimental therapy and reduce the rate of relapse, which is about 50 pTherapy (PLAT - 02) trial with 93 percent of patients with relapsed or refractory acute lymphoblastic leukemia (ALL) achieving complete initial remission, researchers at Seattle Children's are continuing their quest to improve the experimental therapy and reduce the rate of relapse, which is about 50 ptherapy and reduce the rate of relapse, which is about 50 percent.

In the late 1990s medical researchers at NIDDK and in Finland conducted trials combining exercise, diet, and drug therapy as a way to head off diabetes in overweight people with high blood sugar.

«We're at a pivotal point where we're building upon what we've learned in the PLAT - 02 trial and opening new trials, like PLAT - 04, with the goal of improving this therapy to the point that it becomes a long - term cure for all of our leukemia patients,» said Dr. Corinne Summers, an oncologist at Seattle Children's and the lead investigator of the PLAT - 04 trial.