Cardium Therapeutics: An Overview

About Cardium: Overview

Cardium Therapeutics is a medical technology company primarily focused on the development and commercialization of novel biologic therapeutics and medical devices for cardiovascular and ischemic disease. Since we were initially funded in October 2005, we have made three strategic acquisitions and assembled a portfolio of innovative late-stage cardiovascular and regenerative medicine product candidates, together with medical devices having U.S. Food and Drug Administration (“FDA”) clearances that are marketed and sold through our direct sales force. We have established a pipeline of innovative products that are divided into three business units, Cardium Biologics, InnerCool Therapies, and Tissue Repair Company.

Generx™ (alferminogene tadenovec, Ad5FGF-4), Cardium’s lead product candidate, is being developed as a potential treatment for myocardial ischemia (insufficient blood flow within the heart muscle) and associated angina due to coronary heart disease. Generx represents a new therapeutic class of cardiovascular biologics designed to promote angiogenesis, a natural process of blood vessel growth within the heart muscle, to increase blood supply to ischemic areas of the heart following a one-time intracoronary administration. Cardium is recruiting patients for its Phase 3 clinical trial (AWARE) to evaluate the therapeutic effects of Generx in women with recurrent angina who are not candidates for revascularization. Generx represents the first and only DNA-based cardiovascular therapeutic to be advanced to Phase 3, and the Company believes it to be the only current Phase 3 product candidate for the potential treatment of patients with stable angina, a chronic medical condition affecting millions of patients in the U.S. and worldwide.

Cardium’s InnerCool Therapies subsidiary is a San Diego-based medical technology company in the emerging field of patient temperature modulation. Temperature modulation therapy is a rapidly-advancing field focused on preserving ischemic tissue and improving patient outcomes following major medical events such as stroke, cardiac arrest and heart attack, as well as in the management of patients experiencing trauma or fever. InnerCool’s Celsius Control System™ is a thermal regulating system with FDA clearance for the induction, maintainance and reversal of mild hypothermia in neurosurgery and cardiac surgery patients and in recovery/intensive care and for fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. InnerCool's next-generation RapidBlue™ system for high-performance endovascular temperature modulation will include a programmable console with an enhanced user interface and a catheter designed to quickly modulate patient temperature in association with surgery or other medical procedures. The RapidBlue system also may be utilized to automatically cool or warm the patient as necessary to maintain body temperature within the narrow range commonly defined as “normothermia”. The RapidBlue system powers InnerCool’s Accutrol™ catheter, which has a flexible metallic temperature control element (TCE) and a built-in temperature feedback sensor to provide fast and precise patient temperature control. InnerCool’s CoolBlue™ surface-based temperature modulation system includes a console and a disposable CoolBlue™ vest with upper thigh pads, which is designed to provide a complementary tool for use in less acute patients or in clinical settings best suited to prolonged temperature management.

Cardium’s Tissue Repair Company (TRC) subsidiary is focused on the development of growth factor therapeutics that promote tissue repair and regeneration. TRC’s lead product candidate, Excellarate is being developed as a potential treatment of non-healing diabetic foot ulcers. The Excellarate topical gel uses TRC’s Gene Activated Matrix™ (GAM) technology that is designed to provide localized and sustained cellular release of platelet-derived growth factor-BB protein. Providing sustained delivery of PDGF-BB directly at the wound site is believed to stimulate angiogenesis and granulation tissue formation through the recruitment and proliferation of chemotactic cells such as monocytes, endothelial and fibroblasts, which are necessary for the stimulation of a variety of wound healing processes. TRC’s GAM technology may have potential utility in several clinical indications where protein therapeutics have had limited success, including treatment of dermal wounds (such as diabetic foot ulcers), therapeutic angiogenesis (pharmacologically inducing new blood vessel growth), and orthopedic products for repair of various tissues, including hard tissue (bone) and soft tissue (ligament, tendon, cartilage) repair. In November 2007, Cardium initiated the Phase 2b Excellarate clinical trial. The MATRIX (GAM501 for the Treatment of Diabetic Ulcers in the Lower Extremities) clinical study is a randomized, double-blind, placebo-controlled, comparator arm, multi-center clinical study and will enroll approximately 210 patients at an estimated 25 U.S. medical clinics. The MATRIX study is expected to be completed in late 2008.