Sentences with phrase «post-clinical phase trials»

The Finnish drug maker on Sunday presented results from phase I trial of a prostate cancer treatment, saying according the data it «has been well tolerated, with no significant treatment - related adverse events.»

Juno is developing its immunotherapy product candidate, JCAR017, which is in a Phase I trial, studying patients with B - cell Non-Hodgkin Lymphoma [NHL].

It tells the story of «the guinea pigs»» the people most likely to be research subjects in Phase I trials, which test the safety of a drug under development by giving it to healthy subjects and examining any side effects they experience.

Drug company Phase I trials are the domain of those people who claim to make a living as scientific subjects (check out a Wired feature on them here).

Would you say that the phase I trial done by Acambis, based in Cambridge, U.K., and Cambridge, Mass., has been successful?

Although the effectiveness of the new drug is not the main concern of a phase I trial, Dr. Williamson noted it was promising that five of the patients survived more than a year after starting the drug.

The phase I trial is designed foremost to test whether the approach is safe.

«Many of the current Phase I trials for spinal cord injury are run in the acute phase, which is right after injury.

Many vaccines go into phase I trials and never make it.»

«Results in Phase I trial targeting cancer stem cells.»

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.

As a Phase I trial, the primary objective is to establish safety and feasibility of both the initial procedure and the long - term effects.

«The findings provide good support for the general safety of phase I trials,» said lead author Ezekiel J. Emanuel, MD, PhD, chair of the department of Medical Ethics and Health Policy at Penn. «Some have claimed that these trials pose high risks of harm to participants.

Although implantable miniature telescopes are not a cure for macular degeneration, «FDA approval (of VisionCare's technology) will take a very desperate group of people and give them some hope,» says Lane, a principal investigator at Associated Eye Care, who implanted six devices during VisionCare's Phase I trial.

In phase I trials, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

But again, none of these has entered a phase I trial.

«Although still only in an early phase trial, brigatinib is showing an objective response rate in approximately 70 percent of ALK - positive patients post-crizotinib and it's showing about a year of progression - free survival.

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.

Trial # 2: Phase I trial of HCQ with dose - intense temozolomide in patients with advanced solid tumors and melanoma

A phase I trial conducted by investigators at the Colorado State University Veterinary School in 30 dogs with non-Hodgkin's lymphoma with HCQ and the standard chemotherapy doxorubicin (DOX) showed a 100 percent clinical benefit rate.

Nonetheless, many scientists aren't waiting until late - phase trials to voice concerns.

One phase I trial of an immune checkpoint blockade drug combined with two established targeted therapies yielded 40 - 50 percent response rates among patients with metastatic kidney cancer.

«Together with The National Institute for Medical Research Tanzania, we are in the process of preparing phase I trials for a vaccine to prevent parasite binding in the placenta and malaria during pregnancy,» he explains.

This guarded optimism is based on the phase I trial data showing an increase in overall survival of 4 - 6 months in 11 glioblastoma multiforme patients (18 - 22 months) versus the 14 - 16 months survival typically seen with the standard treatment.

In a few weeks, meeting participants learned, enough data may be available from small phase I trials of a vaccine jointly made by the U.S. National Institute of Allergy and Infectious Diseases and GlaxoSmithKline (GSK) that began in September to launch efficacy studies.

Scientists say WHO's vials could have already been shipped to the research centers planning to do phase I trials.

NewLink Genetics of Ames, Iowa, has a second vaccine in a phase I trial that consists of a crippled vesicular stomatitis virus (VSV), which infects livestock, with the gene for the Ebola virus surface protein.

To create a longer - lasting preventive therapy for severe hemophilia A-associated bleeding, a group of Japanese researchers launched a first - in - human Phase I trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACE910, a bispecific antibody that mimics FVIII and works with other clotting factors to make the blood clot properly.

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.

A phase I trial of deep brain stimulation of memory circuits in Alzheimer's disease.

«RNA interference drug demonstrated activity and safety in phase I trial.»

[4] Sabbatini P, Tsuji T, Ferran L, Ritter E, Sedrak C, Tuballes K, Jungbluth AA, Ritter G, Aghajanian C, Bell - McGuinn K, Hensley ML, Konner J, Tew W, Spriggs DR, Hoffman EW, Venhaus R, Pan L, Salazar AM, Diefenbach CM, Old LJ, Gnjatic S. Phase I trial of overlapping long peptides from a tumor self - antigen and poly - ICLC shows rapid induction of integrated immune response in ovarian cancer patients.

Phase I trial - an early clinical trial designed to study an experimental vaccine in humans.

Phase I trials are generally small (less than 100 participants) and designed to see if the product is safe.

In PNP's Phase I trial, an adenoviral vector is used to deliver E. coli PNP to head and neck tumors followed by intravenous administration of the prodrug fludarabine.

Choy, H, Chakravarthy, A. Phase I trial of Irinotecan and concurrent radiation therapy for stage III non-small cell lung cancer.

An anti-PD-1 antibody developed by Bristol - Myers Squibb generates excitement with results from a phase I trial showing that, among 236 patients with various types of cancer, the treatment shrank tumors in 28 percent of melanoma patients, 30 percent of patients with kidney cancer, and 18 percent of patients with advanced non-small cell lung cancer.

Through CRI's Clinical Accelerator program, two new checkpoint inhibitor drugs, MEDI4736 (anti-PD-L1) and tremelimumab (anti-CTLA-4), are being tested in a phase I trial for patients with six different cancer types, including colorectal cancer, cervical cancer, head and neck cancer, kidney cancer, lung cancer, and ovarian cancer.

While this is still only interim data from an early phase trial, this study is a positive result for Spark Therapeutics and Pfizer, as well as future patients.

My translational research interests involve clinical trials evaluating targeted biologic agents, particularly early phase trials with targeted antibodies.

«The impressive and durable response of the single patient with follicular lymphoma on the phase I trial of this agent spoke to its potential in this disease,» Westin added.

Current clinical trials include combination of intrahepatic embolization and a radiosensitizer in patients with uveal melanoma and liver - only metastases, a phase I trial that evaluates a combination therapy of BCG with ipilimumab in Stage III / IV melanoma, and several landmark international trials including a phase II trial that evaluates combination immunotherapy with nivolumab & ipilimumab.

Current estimates are for the Phase I trial to start enrolling 240 participants early in 2015.

[27] Besides BMS - 936558 (Nivolumab), another humanized anti-PD1 antibody, MK - 3475 (Lambrolizumab), has shown activity and acceptable toxicity in a phase I trial with metastatic melanoma.

The paper, «MR Imaging - guided Focal Laser Ablation for Prostate Cancer: Phase I Trial,» appears as an early release in Radiology.

A large phase I trial offers further evidence that the anti — PD - L1 agent avelumab is generally well tolerated and results in relatively few serious adverse events.

Following Dr. Mendell's successful phase I trial described in the NEJM publication, additional studies to enable FDA approval of the first gene therapeutic for a fatal disease of infants are now underway.

The development track will begin with a Phase I trial to test the vaccine regimen's safety and immunogenicity and depending on those study results, a larger efficacy study will follow.

The clinical consortium is led by AFFiRiS itself, and in addition to the PD booster trial, it is now recruiting for a separate Phase I trial of the α - synuclein vaccine against MSA, a synucleinopathy differentiated from PD or LBD based on the cell populations affected, the regional concentration of AS neuropathology, and the spectrum of movement and other symptoms.

Early phase trials with anti-PD-L1 and anti-PD-1 antibodies have shown clinical activity in RCC and early biomarker assessment suggests PD - L1 tumor expression may influence response.