beyond the shire

Dermagraft achieved a higher closure rate of venous leg ulcers than the control but failed to meet the primary end point. Following the pivotal trial, Shire made the decision not to pursue the venous leg ulcer indication. So what was the all important primary end point and how will the bar be set for ReCell?

According to Shire news;
The primary end point of the trial was complete healing by 16 weeks. In addition, there was a need to show a minimum absolute level of superiority over compression therapy.

The results of preliminary studies for the use of ReCell in the treatment of VLUs and DFUs has been 'encouraging'. In total, across a number of open-label studies, ReCell has been used to treat approximately 80 patients.

"Over 70% of patients showed complete healing of the wound within 7-12 weeks following a single treatment with ReCell," excerpt from Avita News Release 20 November 2012.

So how did we do compared to the control or current standard of care?

"With the current standard of care treatment it would be expected that approximately 43% of these wounds would have achieved closure during this period..."

Anything else?
"Pain, a critical indicator of quality of life, was reported as being significantly reduced or eliminated within 72 hours following the ReCell treatment."

It would appear that in the European clinical trial, as well as the proposed pilot trial for the US FDA refer clinical trials website, the primary end point is the difference in incidence of ulcer closure between the ReCell group and the control group after 12 weeks following treatment.

If that is the case then it would appear to be a higher bar than what was set for Dermagraft.