BrainStorm's CEO, Chaim Lebovits, commented "We are pleased that the DSMB
has again identified no concerns following their review of the safety data accumulated for the NurOwn[sup.
The members of the DSMB
approved unanimously the continuation of the trial having concluded that one month post treatment, C-Cure and C-Cathez shows no safety issue that compromises the continuation of the CHART-1 Phase III study.
John Dawson, Chief Executive Officer of Oxford BioMedica, said: "The continued progress of our ophthalmology portfolio, supported by another positive DSMB
review, is encouraging - particularly given that early RetinoStat[sup.
It is crucial that all members of the research team understand the role and responsibilities of the DSMB
when conducting clinical research.
BrainStorm's CEO, Tony Fiorino, MD, PhD, commented "We are gratified that the DSMB
has found no concerns after having reviewed the safety data accumulated for the study through January.
reviewed mortality and other safety data from the first 21 patients enrolled in this single-center trial at Johannesburg Hospital Trauma Unit in South Africa.
advised YM that there were no safety concerns and that the trial
7] Due to the dispute with the company, the study leadership was unable to obtain the final data, and published from the data submitted to the DSMB
, with updates during the summer of 1999.
Additionally, the DSMB
has authorized the Company to treat all three patients in the second cohort of its European trial for SMD.
In the news release, BrainStorm Announces Positive DSMB
Recommendation in Ongoing Phase 2 Trial with NurOwn(TM) in ALS, issued Feb.
will meet again this summer to review both safety and mortality trends when the results from the first 50 percent of enrolled patients have been analyzed.
determined that the patients from the first dosing cohort were clear of any significant treatment-related adverse events.