Within a week, medical technology company Cardium Therapeutics Inc. (CXM) will be reporting preliminary safety and efficacy data from a mid-stage trial of Excellarate, a topical gel that is being developed for diabetic foot ulcers and tissue injuries.
Cardium added Excellarate to its roster following its acquisition of wound-healing technology and related assets of privately-held Tissue Repair Co. in 2006. Excellarate is a DNA-activated collagen gel that stimulates the human body's wound healing process.
According to Cardium, Excellarate is designed to require only one or two physician-administered treatments, in contrast to most diabetic wound healing agents or devices in use that require repeated administrations over a long term (weeks to months). Excellarate is also expected to be re-formulated as an easy-to-use single syringe that is pre-mixed and ready to be applied to patients' wounds. The reformulation will allow Excellarate to be maintained in a physician's office using a standard refrigerator (at a temperature of about 4 C) and is expected to have a shelf life of 15-18 months.
The phase IIb trial of Excellarate dubbed MATRIX, is a prospective, randomized, double-blind, placebo-controlled study for the potential treatment of chronic diabetic foot ulcers. The clinical study is designed to evaluate safety and key efficacy measures including complete wound closure, time to complete wound closure, absolute and percent change in ulcer area, and wound healing trajectories at various time points, as well as a wide range of other safety and comparative healing metrics which will be used to develop a Phase III clinical study.
Apligraf from privately-held Organogenesis Inc; Dermagraft from Advanced Tissue Sciences Inc. (ATISZ.PK); Johnson & Johnson's (JNJ) Regranex Gel are some of the FDA-approved treatments for diabetic foot ulcers.
Foot infections are among the most serious complications of diabetes and may even lead to amputation when infections fail to respond to therapy. Statistics reveal that about 600,000 diabetics get foot ulcers every year in the U.S. According to reports, appropriate treatment of foot ulcers may prevent up to 85% of amputations.
Cardium now has two business units, Cardium Biologics and Tissue Repair Co. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics.
Generx, Cardium's lead product candidate, is under late-stage study in women with angina. Corgentin is the company's pre-clinical product candidate for the potential treatment of cardiovascular disease. Generx and Corgentin are both DNA-based therapeutics. Cardium is evaluating partnering opportunities designed to support the advancement of Generx and Corgentin.
Cardium has yet to generate positive cash flows from operations, and is essentially dependent on debt and equity funding to finance its operations.
Last month, the company announced a common stock private placement to selected investors for aggregate gross proceeds of $4.5 million. The securities in the offering include an estimated 3 million shares of Cardium common stock at a price of $1.50 and warrants to purchase up to 2,225,000 shares of Cardium common stock at an exercise price of $1.77. The warrants are exercisable six months after the date of issuance, and will expire five years from the date of issuance.
Cardium shares, which trade on the AMEX, have lost 22% of their value over the past one month. Will the upcoming catalyst have an impact on the stock price? Stay tuned...
CXM, which has thus far hit a 52-week low of $0.38 and 52-week high of $3.10, is currently up 0.68% trading at $1.48.
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