So if the following results were from a phase 2 fda trial with 53 patients what would you say then?
In the VITRO-CARD-1001 study in a population of patients with previous unsuccessful treatment of their wounds and with a median wound duration of 10 months at baseline, a clinically meaningful overall complete healing rate of 30.2% was achieved in the Full Analysis Set (FAS) and a healing rate of 35.6% in the Completer Analysis Set (CAS) by the end of the 12-week treatment period.
A clinically meaningful median percentage wound area reduction of 61.9% between baseline and final assessment was achieved in the FAS and a median of 70.8% in the CAS. At end of study, 31/53 patients (58.5%) had achieved partial healing by at least 50%, 22/53 patients (41.5%) had achieved partial healing by at least 75% and 16/53 patients (30.2%) had complete healing (i.e. 100% epithelialisation).
In the VITRO-CARD-1001 study, in addition to the achievement of clinically meaningful healing and wound area reduction, patients also achieved substantial pain reduction.
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