ABOUT CARDIUM: Historical Background
Cardiovascular Biologics
In late 2005, Cardium acquired a portfolio of biologic growth factors and related delivery techniques from the Schering AG Group for potential application in cardiovascular disease and other areas of regenerative medicine. Cardium’s Generx® (alferminogene tadenovec, Ad5FGF-4) product candidate is a DNA-based angiogenic growth factor therapeutic product candidate representing a new class of cardiovascular biologics being developed as a potential treatment for patients with advanced coronary artery disease. Generx is designed to stimulate and promote the growth of supplemental collateral vessels to enhance myocardial flood flow (perfusion) following a one-time intracoronary administration from a standard cardiac infusion catheter in the heart of patients who have insufficient blood flow due to atherosclerosis plaque build-up in the coronary arteries. The Generx clinical studies have involved more than 650 patients with heart disease in four double-blinded, placebo-controlled clinical studies at over 100 medical centers in the U.S. and internationally. This represents the most advanced clinical program to develop a new non-surgical alternative for the potential disease-modifying treatment of millions of patients with coronary artery disease. Cardium is considering clinical and commercialization pathways for Generx in developing nations that often have very limited access to surgical approaches such as angioplasty, stenting or coronary artery bypass (which are available to patients in industrialized nations but at costs reaching $80,000 to $100,000 per procedure over a five year period). Additional data gained in parallel studies, which would be expected to be conducted in collaboration with specific regional development partners, would also be expected to support an expanded U.S. registration dossier by providing additional safety data and potentially alternative efficacy measures.
Tissue Engineering Gene Activated Matrix Technology
In August 2006, Cardium acquired the Gene Activated Matrix and other technology from the Tissue Repair Company (TRC). TRC’s Gene Activated Matrix (GAM) technology allows for a broad spectrum of formulations which would include, but not be limited to, collagen, demineralized bone matrices, allograft and synthetic graft materials. Based on data from the Tissue Repair Company’s Matrix Phase 2b clinical trial for the potential treatment of patients with chronic non-healing diabetic foot ulcers, the Company has announced plans for the commercial development of a new product candidate Excellagen™, a collagen-based topical gel, through a FDA 510(k) clearance pathway for potential use by physicians in patients with topical wounds, which include diabetic ulcers as well as pressure ulcers, venous ulcers, surgical and trauma wounds, second degree burns, and other types of wounds. For the Company’s Excellarate™ product candidate, which comprises a mixture of our collagen-based gel with a biologic encoding a stimulatory growth factor (PDGF-B), we plan to introduce a combined formulation that allows for longer term stability without the need to maintain the biologic separately at -70°C, and to introduce the easier to use single-syringe product candidate into Phase 2/3 clinical studies designed to further evaluate the safety and effectiveness of Excellarate, and to allow for repeat dosing of Excellarate for wounds that are responding to treatment but have not yet achieved complete closure. Cardium also plans to develop a DNA-based orthobiologics product portfolio based on a reformulation of the Company’s Excellarate product candidate that will initially focus on non-union bone fractures and spinal fusions.
InnerCool Therapies
InnerCool Therapies was acquired by Cardium in 2006 and as a result of the Company’s efforts was strategically repositioned with a combination of innovative medical devices in the emerging field of patient temperature modulation, leading to the acquisition of the business in July 2009, by Royal Philips Electronics which represents the first asset monetization from the Company’s biomedical investment portfolio.