Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase...(bserved in immunological antibody respon...),Health

Date:10/14/2009

bserved in immunological antibody responses to either collagen or to the adenovector in patients receiving Excellarate as compared to those receiving only standard of care. These findings together with the initial healing rate change over time observed in the Phase 2b study support allowing investigators in future studies to re-dose a subset of patients who have not yet achieved a prespecified rate or extent of wound closure. As a result, subject to review with the FDA, we would consider the inclusion of a re-dosing protocol into the planned Phase 3 clinical study program. Cardium believes that this added feature may offer the potential to further enhance efficacy in practical real world clinical settings by optimizing the interaction between Ad5PDGF-B production, which is believed to occur predominantly over the first few weeks following administration, with the individual patient's underlying physiology within the wound site.

Planned Phase 3 Clinical Program

Following completion of the Phase 2b study's durability phase and a complete statistical data analysis, Cardium plans to meet with the FDA to review the complete clinical trial results and to review the Company's proposed Phase 3 clinical study program. The Company will seek to establish a clinical development plan, which could include a special protocol agreement, to define the size and scope of the proposed program which will be based on the important information acquired from the Phase 1/2 and Phase 2b clinical studies. Based on FDA guidance documents and other clinical studies that have supported other product registrations, the Phase 3 program will include a prospective, randomized, double-blind, controlled multi-center study that will evaluate continued safety and definitive efficacy. Cardium is also planning that this study program will utilize a single primary efficacy endpoint, percent of complete wound closure at 12 weeks or earlier, as compared to standard of care. '/>"/>

SOURCE Cardium Therapeutics Copyright©2009 PR Newswire. All rights reserved

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