From rxpgnews.com
FDA Requests Additional Data for Approval of OrCel(R) in Patients with Venous Leg Ulcers
By Ortec International, Inc,
Apr 30, 2005, 08:28
Ortec International, Inc, (ORTN) announced today that after submitting clinical data that demonstrated clinical significance in both the Intent to Treat (ITT) Population (all patients treated in the trial) as well as those patients with ulcers for which use of OrCel(R) is indicated (partial and full thickness ulcers extending into dermis but not into the fascia), the Food and Drug Administration (FDA) recommended that a confirmatory trial, involving only those patients for which OrCel(R) is indicated, is necessary.
While the FDA indicated the clinical data showed promise for the effective treatment of venous ulcers, and this potential benefit was further reinforced by the clinical data we provided, they believe additional data is necessary to demonstrate reasonable assurance of safety and effectiveness of OrCel(R) in patients with venous leg ulcers.
The FDA believes the analysis of the patients for which OrCel(R) is indicated was not prospectively defined and accordingly recommended an additional prospective clinical trial to confirm Ortec's findings. Ortec estimates that approximately 40 patients will be required in the study.
Ron Lipstein, Vice Chairman and Chief Executive Officer of Ortec, commenting on the FDA's recommendations said, "We feel strongly that we have a safe and effective treatment for venous ulcers and that the approach and statistical methodologies used in the clinical trial were appropriate and similar to those used previously to support FDA approval of comparable products on the market. However, in response to the FDA's recommendation, we will work closely with the FDA to design and undertake the confirmatory trial that is expected to lead to the approval of the PMA for OrCel(R). We, together with our marketing and manufacturing partner, Cambrex, will take the required steps to obtain regulatory approval of OrCel(R)."
Concurrently, Ortec intends to initiate a resolution process with the FDA. As part of this formal process with the FDA, Ortec expects to provide data that will be made available through public filings.
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