Cardium Therapeutics' Matrix phase II b study data accepted for publication by peer-reviewed Journal
Cardium Therapeutics reported that data from the Company's Matrix phase II b 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 II b 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.
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.
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.