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Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase 3 Program
Date:10/14/2009

f the groups, the 31% wound closure rate observed in the SOC group was similar to that observed in prior published studies and substantially lower than that observed for patients receiving Excellarate or collagen alone. Among patients receiving a single dose of Excellarate, there was a 55% relative improvement in complete wound closure by 12 weeks as compared to the SOC group, which is considered to be a key efficacy criterion for a Phase 3 product registration program.

During the course of the Phase 2b Matrix study, some investigators expressed an interest in having the flexibility to re-dose patients (to allow for a second or third treatment during the 12-week study period) in response to observed healing slowdowns or plateaus following an initially rapid healing response among some patients. In addition, while early rapid healing following product administration was not a prespecified efficacy measure, the unblinded Phase 2b data revealed that patients receiving Excellarate exhibited a 108% relative improvement (decrease in ulcer radius) as compared to SOC over the first week following a one-time administration of product, and a 50% relative improvement was observed as an average over the first four weeks. The Phase 2b clinical study included a second dose treatment cohort, but the observed healing slowdowns or plateaus did not necessarily coincide with the protocol's established second dosing at week 4 following initial dosing, and a number of patients prespecified by randomization to receive a second dose either did not require it (because their wounds had already closed) or received only an extremely small second dose (because their wounds were almost closed). Based on continuing safety data from the Matrix Phase 2b study, as well as the open label Phase 1/2 clinical study and preclinical research, all of which included some re-dosing, the Excellarate product candidate appears to be both safe and well tolerated, with no significant differences o
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SOURCE Cardium Therapeutics
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Related medicine news :

1. Cardium Announces Commercial Development of Excellagen(TM) a Customized Collagen-Based Topical Gel for Initial Use as an Adjunct to Surgical Debridement in Patients With Diabetic Foot Ulcers
2. Scientific Journal Gene Therapy Reports That Cardiums Gene Activated Matrix Technology Accelerates Periodontal Tissue Regeneration
3. Cardium Reports on Second Quarter 2009 Financial Results and Recent Developments
4. Cardium Completes Sale of InnerCool Therapies Business to Royal Philips Electronics
5. Cardium Receives Preliminary Notification of Inclusion in the Russell 3000(R) Index and Russell Global(R) Index
6. Cardium Presents Gene Activated Matrix Technology and Update on Excellarate Clinical Development Program at ASGT Annual Meeting
7. Cardium Reports on First Quarter 2009 Financial Results and Recent Developments
8. Cardium Reports on New Excellarate(TM) Product Formulations to Expand Commercialization Potential Into Multiple Wound Healing Applications
9. Cardium Provides Update Regarding Exchange Listing Compliance Plan Accepted by NYSE Amex
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11. Cardium Reports on Recent Highlights, Financial Results and 2009 Outlook
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