The drug is currently approved for certain patients with unusually high triglyceride levels."The worried well shouldn't run out and take fish oil," said Dr Michael Shapiro, a site investigator
for the Reduce-IT trial and the director of Oregon Health and Science University's atherosclerosis imaging program.
Two SAEs were reported and both were determined by the site investigator
to be due to primary MPS II disease and unrelated to SB-913 treatment.
Enrollment and further dosing are on hold in this trial while the company, its partner and the FDA work closely with the site investigator
to review this event in detail and to resolve this clinical hold.
Catherine Lomen-Hoerth served as a site investigator
for University of California, San Francisco, and was involved with study planning and data collection.
GERMANTOWN, Md., September 22, 2014-After three years, three clinical trial patients with amyotrophic lateral sclerosis (ALS) who received high-dose spinal stem cell injections showed significant slowing of the progression of the disease, according to Jonathan Glass, site investigator
at Emory University.
GERMANTOWN, Md., September 22, 2014 -- After three years, three clinical trial patients with amyotrophic lateral sclerosis (ALS) who received high-dose spinal stem cell injections showed significant slowing of the progression of the disease, according to Jonathan Glass, site investigator
at Emory University.
Fried reported receiving support from Reata Pharmaceuticals as a site investigator
for a study.
Wehner, an active researcher involved in several projects, is the principal site investigator
After consent, the site investigator
initiated a 2-hour observational period at the beginning of the next hour (e.g., if consent was obtained at 2:34 P.M., observations started at 3:00 P.M.).
Mina C Hosseinipour of the University of North Carolina Chapel Hill, and a site investigator
for the study in Malawi, discussed her analysis of trial outcomes by region.
Saxon has served as a consultant to Reckitt Benckiser, and was a site investigator
for the Titan-sponsored buprenorphine implant study.
The site investigator
"considered that this event was possibly related to vaccination," the researchers stated.