Cardium Therapeutics, Inc. Announces Agreement With bioRASI to Advance and Broaden Clinical Development of Generx Product Candidate
Published: Feb 17, 2010
SAN DIEGO, Feb. 16 /PRNewswire-FirstCall/ -- Cardium Therapeutics today announced that it has entered into an agreement with bioRASI, an international contract research organization, to assist Cardium in the evaluation of Generx clinical development opportunities within major newly-industrializing markets in Eastern Europe, Asia and Latin America, for patients with chronic coronary artery disease who are either not optimal candidates for or do not have access to costly angioplasty/stenting or cardiac bypass surgery procedures.
Despite progress in the care and treatment of patients with cardiovascular disease in the industrialized world, heart disease remains a very serious problem in the U.S. and Europe, and advanced surgical procedures have been associated with considerable and increasing expense within already-burdened healthcare systems. The situation is even worse in other parts of the world. In many industrializing countries such as China, India and Russia, as well as in Latin America and the Middle East, the incidence of heart disease is rapidly increasing, and healthcare systems in many of these countries are unable to provide wide access to relatively expensive procedures such as coronary angioplasty and stenting, or cardiac bypass surgery (which in the U.S. can cost $50,000 to $100,000 over a five-year period following initial treatment).
"This agreement with bioRASI represents an initial step forward to expand Cardium's access to new avenues for clinical and commercial development of our Generx product candidate in major global markets that are experiencing rapidly advancing cardiovascular disease but have much more limited use of costly surgical revascularization procedures. bioRASI's international clinical research experience is expected to provide a cost-efficient means of advancing our Generx product development efforts and expanding our clinical database to support the potential commercialization of this novel product candidate. Based on data indicating that Generx appears to safe and has the potential to substantially increase coronary blood flow in the context of heart disease, together with an independent 10-year study that underscored the apparent significance of coronary circulation for long-term cardiac health, we believe that our Generx product candidate could be developed as a front-line therapy for coronary artery disease from a more global perspective. Additional data gained from parallel studies would also be expected to support an expanded U.S. registration dossier by providing additional safety data and potentially alternative efficacy measures," stated Christopher J. Reinhard, Cardium Chairman and Chief Executive Officer.
Positive results from the Phase 2a mechanism of action clinical study (Grines et al., J Am Coll Cardiol 2003; 42:1339-47) showed that Generx improved myocardial blood flow in the ischemic region of the hearts of men and women following a single intracoronary infusion as measured by the objective efficacy endpoint of SPECT imaging. As noted in the publication, the mean change observed in Generx-treated patients was a 4.2% absolute reduction (which represents a 20% relative reduction) in the reversible perfusion defect size from baseline at eight weeks (p<0.001), while the placebo group showed only a 1.6% absolute reduction from baseline (not significant) at eight weeks following treatment. The observed treatment effect for patients receiving Generx was similar in magnitude to that reported in the literature for patients undergoing angioplasty/stent or revascularization procedures with reversible perfusion defects of comparable size at one year following these procedures.
An independent long-term study published in Circulation (Meier et al, Circ. 2007; 116:975-983) provided key evidence indicating that men and women with more recruitable collateral circulation have a better chance of surviving a heart attack than patients who have less developed collateral circulation. This important study quantitatively evaluated coronary collateral blood flow in 845 patients with coronary artery disease during a 10-year follow-up period and showed that long-term cardiac mortality was approximately 66% lower in patients with a highly developed collateral vessel blood supply (p=0.019). For the first time, this study showed the importance of collateral circulation beyond simply the relief of angina and provided further support of the potential for long term benefits from angiogenic therapy.
Generx Product Candidate
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
CONTACT: Bonnie Ortega, Director, Investor/Public Relations, of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web site: http://www.cardiumthx.com/