Cardium Therapeutics reported on recent clinical findings published in the December issue of Diabetes Care showing an increase in mortality in diabetic patients with a history of foot ulcer (HFU) compared with diabetic patients without HFU and with non-diabetic patients.

The study titled, 'A history of foot ulcer increases mortality among persons with diabetes. 10-year follow-up of the Nord-Trondelag Health Study, Norway', (Diabetes Care. 2009 Dec;32(12): 2193-9. Epub 2009 September 3) followed 63,632 non-diabetic individuals, 1,339 diabetic patients without a history of foot ulcers, and 155 diabetic patients with a history of foot ulcers for 10 years with mortality as the endpoint. During the 10-year period, 49.0 per cent of adults with diabetes and a history of foot ulcers died compared to 35.2 per cent with diabetes and no HFU and 10.5 per cent without diabetes. With adjustments for lifestyle and demographic factors, diabetic patients with HFU were more than two times more likely to die during the follow up period than the subjects that were non-diabetic. Comparing diabetic individuals, a HFU was associated with 47 per cent increased mortality. The increased risk persisted after adjustment for co-morbidity and depression scores.

The prevalence of diabetes is rapidly increasing and it is predicted that by the year 2025, an estimated 300 million people in the world will have the disease. One of the most common complications of diabetes is the development of lower extremity ulcers and in the US about 15 per cent of the almost 24 million diabetics, or 3.6 million people, will develop these wounds.

"This new study shows that a history of diabetic foot ulcers is a predictor of mortality in diabetic patients. In addition to finding new ways to educate diabetic patients on how to avoid developing ulcers, it is also important to provide health care providers with a wide array of advanced care technologies to treat these wounds when they do occur. We recently announced the submission of our US FDA 510(k) premarket notification of our Excellagen collagen protein-based wound management product candidate, which represents an important step forward in the commercialization of our Excellagen technology platform. Our advanced wound healing technology platform also involves Cardium's Gene Activated Matrix technology which covers DNA-based wound healing, as well as DNA-based orthobiologics," reported Christopher J Reinhard, Cardium's chairman and chief executive officer.

Cardium recently reported on data from the Matrix phase-2b clinical trial of Excellarate for the potential treatment of patients with chronic non-healing diabetic foot ulcers based on its Gene Activated Matrix technology platform. The study evaluated patients treated with the Excellarate product candidate (combination of Ad5PDGF-B and 2.6% collagen) or 2.6% collagen alone compared to patients who received only the protocol specified standard of care. Nearly half of patients (48%) receiving a one-time Excellarate treatment had complete wound closure by 12 weeks, compared to a 31% wound closure rate for standard of care. Among combined one and two dose groups of Excellarate approximately 41% of patients achieved complete closure by 12 weeks. The Company plans to schedule a meeting with the FDA in early 2010 to review the complete integrated data set and outline plans for a Phase 3 clinical study programme designed to confirm the safety and effectiveness of Excellarate as compared to standard of care, since PDGF-B is known to contribute to the biologic process of wound healing and is itself an approved protein product for use in advanced wound care. Cardium believes that the combination of collagen and PDGF-B as provided by the Excellarate product candidate holds the potential to further promote wound healing in non-healing diabetic foot ulcers and other difficult-to-treat wounds.

On December 3, 2009, the company filed a 510(k) premarket notification with the US Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen product candidate based in part on the positive data from the company's phase-2b clinical trial that demonstrated substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen. Excellagen is an advanced wound care device composed of highly-refined, soluble bovine dermal collagen (Type I), which is modified to reduce immunogenicity and promote its usefulness in wound settings. Excellagen is designed for use by health care professionals in patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds. The company plans to develop additional new product opportunities by incorporating other agents into Excellagen formulations, including antimicrobials, DNA and/or other biologics, which are designed to address particular wound healing and other tissue repair applications.

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.