SAN DIEGO, Dec. 28, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported that data from the Company's Matrix Phase 2b clinical study has been accepted for publication in the journal, Wound Repair and Regeneration and provided an update on plans for commercialization of its Excellagen formulated collagen topical wound dressing.
The clinical paper now accepted for publication is titled, "Formulated Collagen Gel Accelerates Healing Rate Immediately after Application in Patients with Diabetic Neuropathic Foot Ulcers", and was authored by nine investigators who participated in the Matrix study and Cardium researchers and is expected to be published in early 2011. Excellagen formulated collagen topical gel wound care dressing was studied in a controlled, double blind Matrix Phase 2b clinical study of chronic diabetic lower extremity ulcers. Wounds treated with the Excellagen formulated collagen (2.6%) topical gel showed a statistically significant acceleration of wound healing during the first week following a one-time application compared to patients receiving standard of care therapy, a response that was sustained over a 14 day period. The authors suggest that more frequent applications of Cardium's Excellagen product candidate hold promise to significantly improve overall incidence of complete wound closure.
The Company also provided an update with respect to planned commercialization of its Excellagen topical gel wound care dressing, which comprises a specially formulated collagen matrix gel being produced under a supply agreement with Devro Medical Limited, part of Devro PLC, a public limited company registered in Scotland. Certain changes to the manufacturing process for the collagen matrix being prepared at Devro will require modified regulatory submissions under the FDA 510(k) process, which are expected to be filed in first quarter 2011.
About Wound Repair and Regeneration
Wound Repair and Regeneration is the official journal of The Wound Healing Society, The European Tissue Repair Society, The Japanese Society for Wound Healing, and The Australian Wound Management Association. Wound Repair and Regeneration provides extensive international coverage of cellular and molecular biology, connective tissue, and biological mediator studies in the field of tissue repair and regeneration and serves a diverse audience of surgeons, plastic surgeons, dermatologists, biochemists, cell biologists, and others. Additional information about Wound Repair and Regeneration can be found at the following web link: http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1524-475X.
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium healthy lifestyle product platform. The Company's lead product candidates include Excellagen™ topical gel for wound care management, and Generx® DNA-based angiogenic biologic for patients with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at www.cardiumthx.com.
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that manufacturing changes and modified regulatory submissions will be efficiently and effectively accomplished and that the U.S. Food and Drug Administration will grant marketing clearance of our product candidates; that we or a partner can successfully introduce our products into advanced wound care markets; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures; that our product candidates will be perceived as being sufficiently safe and effective to lead to product advancement or partnering; that our product candidates offer the potential for simpler or more cost-effective treatments for physicians and patients than other products that currently are or will be on the market; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or its perceived value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; that discussions with potential strategic partners will be successful or that any partner will be able to efficiently and effectively commercialize our products in U.S. or international markets; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of biologics and other therapeutic products and devices, and in the conduct of human clinical trials and other product development efforts, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition and regulation, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved.
Cardium Therapeutics™ Generx® and MedPodium™ are trademarks of Cardium Therapeutics, Inc.
Tissue Repair™, Gene Activated Matrix™, GAM™, Excellagen™, Excellarate™, Osteorate™, Appexium™ and Linee™ are trademarks of Tissue Repair Company.
(Other trademarks belong to their respective owners)
SOURCE Cardium Therapeutics