The trial's advancement to the final patient cohort
comes as the result of its satisfactory standard of safety.
"Having completed the second, higher-dose patient cohort
in all three of our clinical trials in the U.S.
"The FORWARD results with a large patient cohort
are encouraging, as these data support the clinical safety and effectiveness of the Evolut R System," said Prof.
Each trial will enroll a total of 12 patients, with cohorts of three patients each in an ascending dosage format, from 50,000 hESC-derived RPE cells in the first patient cohort
to 200,000 in the last and final cohort.
M2 EQUITYBITES-August 28, 2013-HeartWare International Inc gets US FDA's approval to begin enrollment in additional patient cohort
for ENDURANCE, including enhanced blood pressure monitoring(C)2013 M2 COMMUNICATIONS http://www.m2.com
clinical trial was treated at Moorfields Eye Hospital in London, U.K., and on April 24 the company announced DSMB approval to treat the second patient cohort
in its U.S.
"Analysis of the patient cohort
from the four-year global ENGAGE registry included several anatomically challenging sub-groups: short, highly angulated, and calcium/thrombus burdened AAA necks.
Medicine company Advanced Cell Technology Inc (OTCBB:ACTC) reported on Monday the initiation of the treatment of the first patient with better vision in the patient cohort
2a of its US clinical trial for Stargardt's Macular Dystrophy (SMD), a form of juvenile macular degeneration.
According to the company, the trial is progressing quickly with only one more patient cohort
of four patients to treat.
This interim six-month data from the first patient cohort
in the company's Phase I/II clinical trial of its proprietary HuCNS-SC product candidate (purified human neural stem cells) for chronic spinal cord injury continues to demonstrate a favorable safety profile.
Subjects enrolled had a mean injury severity score of 38.4 +/- 14.4 and 70 percent of BTAI extent was grade III or higher, including one grade IV free rupture, indicative of this extremely high-risk patient cohort
. The extent of arch repair required full or partial left subclavian artery coverage.
The first trial, conducted together with the American Institute for Diseases of the Prostate, examined an international patient cohort
to determine more specifically prostate cancer's molecular profile as well as discover novel, potentially efficient treatment combinations for advanced refractory patients.