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.
Not exact matches
Would you say that the
phase I
trial done by Acambis, based in Cambridge, U.K., and Cambridge, Mass., has been
successful?
Researchers at the National Institute of Biomedical Imaging and Bioengineering (NIBIB) have developed a new radiotracer to diagnose prostate cancer and conducted a
successful Phase I clinical
trial.
► In a news feature in this week's Science, Ken Garber described the surprisingly, frustratingly messy path of palbociclib, one of the most promising cancer treatments to come along in years, from its conception in 1995 through its recent,
successful phase - II clinical
trial.
One
successful compound, named Exel 647, that targets nonsmall - cell lung cancer in previously untreated patients is now in a
phase 2 clinical
trial.
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.
In the most
successful of the
Phase III lymphoma clinical
trials, the course of treatment consisted of seven immunizations given over 24 weeks.
In September, Alnylam Pharmaceuticals announced that its small RNA molecules silenced the gene that causes the progressive disease hereditary ATTR amyloidosis in a
successful phase III
trial.
In these diseases — even though it has been in clinical
trials, it has not been
successful, but it has gone through
Phase I and
Phase II safety and dosing requirements.
What are the odds that a company entering a
Phase 1
trial today can see its candidate all the way through a
successful Phase 3
trial?
Following
successful nonhuman primate studies,
Phase I safety
trials in humans can begin.
Contrast this to the over 5,800
successful clinical
trials using non-fetal stem cells to treat diseases that are already advancing to
phase II and
phase III
trials.
Successful completion of the
Phase 1b
trial is expected to support
Phase 2/3 development programs for Alzheimer's disease, as well as for Parkinson's disease.
Prothena announced the dosing of the first
Phase Ia subject on April 8, 2014; they appear to have been
successful in recruiting subjects and to have quickly derived favorable safety signals, as they announced the dosing of the first PD volunteer in the
Phase Ib
trial on July 31, 2014, «based upon safety and tolerability observed to date in the ongoing study in healthy volunteers.»
«The initiation of the NPT088
Phase 1b
trial is supported by a substantial preclinical development program and the recent
successful completion of a
Phase 1a study in healthy volunteers.
If
successful, this method will be tested at scale by an industrial partner who will generate clinical - grade material for a
Phase 1
trial at the end of this five - year grant.
This
successful program was the first product that reached a
phase I clinical
trial for LigoCyte Pharmaceutical.
If the
Phase I
trial proves
successful, the compound must pass further stages of
trial over the next few years before it becomes available to patients.
«If we are
successful in this stage we would then look to start
phase I clinical
trials.»
Under the terms of the January 2012 agreement, Isis is responsible for global development and Biogen Idec has the option to license the compound until completion of the first
successful Phase 2/3
trial.
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