As previously announced, the FDA advised Ortec that it believed that the patients in which OrCel was shown to be statistically significant were not prospectively defined in Ortec’s protocol. Accordingly, the FDA recommended that an additional trial involving only patients with typical venous ulcers (tissue damage through the dermis but not into the underlying fascia) be conducted to confirm Ortec’s findings.
The clinical data from the 12-week pivotal trial submitted as part of Ortec’s PMA showed that in typical venous ulcers (those ulcers to be evaluated in the confirmatory trial), 59% of the OrCel-treated patients achieved wound closure versus 36% of the patients who received the standard of care treatment (p = 0.034) as well as a statistically significant differential in the rate of healing (p < 0.0001). In addition, these wound closure results were supported by the results generated for all patients treated in the trial when appropriately adjusted for prognostic factors known to impact wound healing (eg, depth of tissue damage, ulcer size, and ulcer age) (p = 0.0058) with OrCel-treated patients also having 64% less recurrence (p = 0.039).
In a previous 36-patient, 12-week pilot study evaluating OrCel in the treatment of venous ulcers (using a non-frozen version of OrCel), OrCel performed similarly with 53% of the OrCel-treated patients achieving wound closure compared to 26% of the patients treated with the standard of care.
The protocol, clinical design, and statistical methodology have been reviewed extensively by the FDA to ensure that the data generated in the upcoming confirmatory trial will be combinable with the data from the pivotal trial.
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