BioRestorative Therapies, Inc. (BRTX) reported that the FDA has cleared an important amendment to the protocol of the ongoing phase 2 study investigating the use of BRTX-100, the lead cell therapy candidate, in treating chronic lumbar disc disease. The protocol amendment removes saline injection in the control arm of the study and replaces it with a sham injection.
"The FDA clearance of this important amendment highlights our positive relationship with the agency, brings additional safety to our subject participants, and helps preclude the possibility of transient clinical outcomes in the control group, which can impact end of study readouts," said Lance Alstodt, BioRestorative's CEO.
Shares of BioRestorative Therapies are up 30% in pre-market trade on Tuesday.
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