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Bone Therapeutics completed recruitment of 16 patients in the Phase I/IIA delayed-union fracture study of ALLOB® allogeneic cell therapy product.
Overall, recruitment for the ongoing 6-month open-label trial is set to target 32 patients, but this could be stopped after a positive evaluation of interim data analysis of the first 16. To date, subjects have received a single percutaneous administration of ALLOB directly into the fracture. Initial results from the first 8 patients showed that >85% were responding according to the protocol.
Presently, ALLOB is undergoing study in the treatment of delayed-union fractures, spinal fusion and failed spinal fusion.
Sources: Bone Therapeutics, Inc.; ORTHOWORLD Inc.
On adaptive designs in clinical trials:
“When you’re conducting a study and have interim analysis, and see that you’ve hit your efficacy goal endpoint early, you are actually then allowed to stop enrolling,” Anastasi says. “You still have to continue to follow up with enrolled patients, but you can go to the panel or FDA much earlier because you met your endpoint. Conversely, it’s also of tremendous value if you get to that interim analysis, look at your endpoint and realize that it’s underpowered and you’re not going to hit it. You can end early for futility or decide to repower your study. If it’s that much underpowered, clients usually end early for futility, take the cost savings for ending the study early, then redesign the product and start a new study.”
—Vicki Anastasi, ICON plc, “Adaptive Designs Provide Clinical Trial Flexibility,” BONEZONE December 2015
Bone Therapeutics completed recruitment of 16 patients in the Phase I/IIA delayed-union fracture study of ALLOB® allogeneic cell therapy product.
Overall, recruitment for the ongoing 6-month open-label trial is set to target 32 patients, but this could be stopped after a positive evaluation of interim data analysis of the first 16. To date,...
Bone Therapeutics completed recruitment of 16 patients in the Phase I/IIA delayed-union fracture study of ALLOB® allogeneic cell therapy product.
Overall, recruitment for the ongoing 6-month open-label trial is set to target 32 patients, but this could be stopped after a positive evaluation of interim data analysis of the first 16. To date, subjects have received a single percutaneous administration of ALLOB directly into the fracture. Initial results from the first 8 patients showed that >85% were responding according to the protocol.
Presently, ALLOB is undergoing study in the treatment of delayed-union fractures, spinal fusion and failed spinal fusion.
Sources: Bone Therapeutics, Inc.; ORTHOWORLD Inc.
On adaptive designs in clinical trials:
“When you’re conducting a study and have interim analysis, and see that you’ve hit your efficacy goal endpoint early, you are actually then allowed to stop enrolling,” Anastasi says. “You still have to continue to follow up with enrolled patients, but you can go to the panel or FDA much earlier because you met your endpoint. Conversely, it’s also of tremendous value if you get to that interim analysis, look at your endpoint and realize that it’s underpowered and you’re not going to hit it. You can end early for futility or decide to repower your study. If it’s that much underpowered, clients usually end early for futility, take the cost savings for ending the study early, then redesign the product and start a new study.”
—Vicki Anastasi, ICON plc, “Adaptive Designs Provide Clinical Trial Flexibility,” BONEZONE December 2015
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
