A new cancer drug known as BLU - 667 has moved through
phase I human trials, and the results are promising.
An Ebola vaccine made by GlaxoSmithKline (GSK) in Rixensart, Belgium, is the furthest along, having entered
phase I human trials on 2 September.
Several drugs and vaccines have shown promise in nonhuman primates, but none of them have successfully made it through
phase I human trials.
Indeed, the authors note the speed with which a second FDA - approved drug believed to have promise in subduing HIV, Deferiprone, has moved directly from tests in culture to
a phase I human trial conducted in South Africa, thanks to previously published results now reinforced by additional research in culture described in the current paper.
Not exact matches
Now that they've demonstrated the significance of insulin signaling in the
human mammary gland, they are planning a
phase I / II clinical
trial with a drug used to control blood sugar in type 2 diabetes to determine whether it improves insulin action in the mammary gland, thus improving milk supply.
ACT is now performing early -
phase clinical
trials testing the safety of implanting retinal cells derived from
human ES cells into the eye to treat certain types of blindness.
A
phase II clinical
trial is just beginning to evaluate whether prolonged application of one of the most potent good bacteria from
human skin can provide long - term protection against S. aureus and improve atopic dermatitis.
At the moment there are no therapies for
humans and animals, but many new variants of immunotherapy have entered
trial phase.
«Most pain medications that have been tested in the past decade have failed in
phase II
human trials despite performing well in animal models,» notes Clifford Woolf, MD, PhD, director of Boston Children's F.M. Kirby Neurobiology Center and a co-senior investigator on the study with Michael Costigan, PhD.
Samuel Weiss, PhD, Professor and Director of the HBI, and Research Assistant Professor Artee Luchman, PhD, and colleagues, published their work today in Clinical Cancer Research, which is leading researchers to start a
human phase I / II clinical
trial as early as Spring 2015.
«The next step is to pursue
Phase 1
trials in
humans.»
J147 has completed the FDA - required toxicology testing in animals, and funds are being sought to initiate
phase 1 clinical
trials in
humans.
Sangamo biochemist Philip Gregory notes that this
Phase 1 clinical
trial is the first
human test of an entirely new class of drug that could turn any gene on or off, depending on the disease.
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.
Today, preparations are being made to begin
phase IIa
human trials on this promising compound as a single - dose cure.
He and colleagues are collaborating with the Sanford Burnham Prebys Medical Discovery Institute to design new assays to discover the next generation of CRF receptor - 1 antagonists for testing in early
phase human safety
trials.
It is the first and largest
phase III randomized controlled
trial of stable, synthetic
human angiotensin II.
They have the opportunity to be exposed to a wide variety of clinical and patient - oriented research, from
Phase I, II, and III
trials to collection of samples and clinical data used to identify genetic variation that leads to
human disease.
«Right now, one of the biggest areas of failure is in
phase II
trials, when you get to those places where you're looking for efficacy and you suddenly discover that the compound that worked great in your animal model doesn't do much in
humans,» he says.
The
phase II
trial, which involves 28 kids from 16 countries, is the first to evaluate a therapy in
humans against this disease.
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.
«The first
phase of clinical
trials are tests of
human safety, so this is a promising start,» Alvey said.
«The immune responses are there, the tough call is whether they're enough to protect
humans against Ebola, and I guess we'll find that out in the
phase 3
trial,» says Adrian Hill, director of the Jenner Institute in Oxford, UK, who is leading a small safety
trial of the monovalent NIAID / GSK vaccine.
And because their signal blocker is an antibody already in
phase I clinical
trials for cancer treatment, they're hoping to make a quick jump into
human testing for cardiovascular disease.
Despite encouraging evidence from animal studies that it clears amyloid from the brain, when it came to clinical improvements in
human patients the drug proved no better than placebo in two
phase III clinical
trials.
Based on this success, the method is now in
phase I
human clinical
trials.
But the new formulation hadn't been through
phase I safety
trials in
humans and so couldn't be used in Ebola patients.
The transition from this first
human trial to a
phase 3
trial marks T2, the second level of translational research.
Won Soon Park, MD, PhD, and colleagues from Samsung Medical Center and Biomedical Research Institute, Seoul, Republic of Korea, conducted a
phase I, single - center
trial of intratracheal transplantation of
human umbilical cord blood - derived mesenchymal stem cells to nine very preterm infants (24 - 26 weeks gestational age) who were at high risk of developing BPD.
One such anti-IFNAR, anifrolumab, is currently being evaluated in a
phase 3
human clinical
trial for treating other aspects of lupus.
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.
The research, part of a
phase I clinical
trial to test the safety of the treatment, was published as a letter to the editor in The New England Journal of Medicine earlier this week and will be in the September issue of
Human Gene Therapy.
In
humans, sample sizes this large are not unusual for
phase III clinical
trials (21).
Now that proof of concept has been demonstrated, Hooper said, the next step is to secure funding and approval for
Phase I clinical
trials in
humans to assess the safety profile of the antibodies.
Clinical
trials for several vaccines are in various
phases, with promising published results in
humans.
This has yielded three Tuberculosis vaccine candidates undergoing
phase IIa testing and three first - in -
human trials of novel CMI - inducing adjuvants.
This led to initiate an overseas, randomized controlled registered
phase I / II
trial in
humans including 70 chronic SCI patients.
Phase II
trial - an intermediate clinical
trial for studying an experimental vaccine in
humans.
Phase I
trial - an early clinical
trial designed to study an experimental vaccine in
humans.
A
Phase 1/2
trial to assess safety, tolerability, and efficacy of the product in
human subjects with diabetes, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was launched in September 2014, and the first implant was announced in October 2014.
PALLAS: Palbociclib Collaborative Adjuvant Study: A Randomized
Phase III
Trial of Palbociclib with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR +) /
Human Epidermal Growth Factor Receptor 2 (HER2)- Negative Early Breast Cancer
PHILADELPHIA --(April 19, 2018)-- The Wistar Institute and partners at the Perelman School of Medicine at the University of Pennsylvania, Inovio Pharmaceuticals, and GeneOne Life Science were recognized among the Top 10 Clinical Research Achievement Awards by the Clinical Research Forum for their ground - breaking
phase 1 DNA - based Zika vaccine research — the first
trial of a Zika vaccine in
humans, which proved safe and effective.
iBET's infrastructure comprises 16 laboratories fully equipped with state - of - the - art technology (70 m2 each), including a BSL2 laboratory for working with viruses; a GMP Analytical Services Unit certified by the INFARMED (the Portuguese medicines authority, EMA Portuguese branch) and by DGAV (the Portuguese veterinary authority) for quality control and batch release of
human and veterinary pharmaceuticals, biopharmaceuticals as well as experimental new drugs; a GMP Mass - Spectroscopy Unit that provides state - of - the - art MS services to the scientific community and Industry; a 2600 m2 bio-pilot plant supporting production and purification of proteins ATMPs and vaccines from bench top to 300 L scale and privileged access to GeniBET Biopharmaceuticals, an iBET spin - off producing ATMPs under cGMP certification for
phase I / II / III clinical
trials.
The Walter Reed Army Institute of Research (WRAIR) began vaccinations today in a
Phase 1
human clinical
trial to test the safety and immunogenicity of the Zika purified inactivated virus (ZPIV) vaccine.
One of the drugs I have developed is currently in
Phase I
human clinical
trials for the treatment of dry AMD.
At the International Society for Stem Cell Research 2017 Annual Meeting (June 14 - 17, 2017; Boston, USA), Asterias Biotherapeutics, Inc (CA, USA) will present new 9 - month efficacy and safety data from their ongoing SCiStar
Phase I / IIa
trial of
human embryonic stem cell - derived oligodendrocyte progenitor cells.
Andy has over 10 years of experience in clinical
trial management, specializing in early
phase, first - in -
human, global studies.
The
Human Trial is following one research team and a handful of trial patients as they move from the lab through the first two years of the Phase 1/2 clinical t
Trial is following one research team and a handful of
trial patients as they move from the lab through the first two years of the Phase 1/2 clinical t
trial patients as they move from the lab through the first two years of the
Phase 1/2 clinical
trialtrial.
Human embryonic stem cellsImage: Wikimedia commons, Nissim Benvenistylinkurl: Advanced Cell Technology; http://www.advancedcell.com/ (ACT) filed an Investigational New Drug (IND) application yesterday (November 18) to conduct a
phase I / II
trial using hESCs to treat a genetic eye disease.
I have developed a program to translate our laboratory discoveries into the clinic which has led to 10 novel antibodies and recombinant proteins progressing successfully through first - in -
human,
Phase I and II cancer
trials.