BioRestorative Therapies (BRTX) said Friday that its autologous stem cell therapy BRTX-100 showed a more than 50% improvement in function and reduction in pain in a "significant" portion of subjects in a phase 2 chronic lumbar disc disease trial.
More than 74% of subjects showed an over 50% improvement in function and more than 72% of subjects showed an over 50% reduction in pain by 52 weeks, the biotechnology company said.
The US Food and Drug Administration requires a greater than 30% improvement in function and reduction in pain to determine whether the clinical trial will go ahead and ultimately receive biologics license application approval, the company said.
The company also said that there were no serious adverse events or dose-limiting toxicities between 26 and 104 weeks at the target dose.
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