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Innogenetics (INGTF.PK) Release: LyphoDerm Final Results In Hard-To-Heal Ulcers Confirmed And Strengthened
10/19/2005 5:11:24 PM
XCELLentis, a wholly owned subsidiary of Innogenetics, today announced the final results of its open-label phase 2 clinical trial with LyphoDerm™ for the treatment of hard-to-heal venous leg ulcers. In addition to confirming the previous topline results announced in early March 2004, further analyses provide new evidence of potential treatment effectiveness in this difficult-to-treat condition.
Confirmation of topline results:
In September 2002, XCELLentis initiated a randomized, open-label, parallel-group phase 2 clinical trial involving 193 patients with hard-to-heal venous leg ulcers, treated at 24 centers in Europe. Patients treated with LyphoDerm™ (a human keratinocyte lysate in a proprietary topical formulation) (n=95) were compared to controls receiving standard of care alone (n=45) or standard with the proprietary topical formulation (n=53).
The primary endpoint to measure effectiveness was the incidence of complete wound closure within 24 weeks. Final results reconfirm those communicated in the press release of March 2, 2004, namely a difference of 11% between LyphoDerm™ and the combined controls. The number of patients achieving 100% wound closure with LyphoDerm™ amounted to 38% (36/95), whereas in the control group this remained 27% (26/98).
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