Cardium Announces Agreement With bioRASI to Advance and Broaden Clinical Development of Generx Product Candidate

SAN DIEGO, Feb. 16 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) 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.

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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).

The U.S. Food and Drug Administration (FDA) has cleared Generx for a Phase 3 clinical study in the U.S. for women with late stage coronary artery disease who are unresponsive to traditional drug therapy and are not appropriate candidates for mechanical revascularization (angioplasty/stents or by-pass surgery), in connection with which Cardium previously announced plans to introduce an improved formulation of Generx that would not require storage at -70 degrees C.  In view of published results from an independent 10-year study among men and women with chronic coronary heart disease showing that improved collateral circulation was associated with approximately 66% lower cardiac mortality, and prior studies showing that a one-time infusion of Generx has the potential to achieve improved coronary collateral circulation in both men and women at levels approximately equivalent to bypass surgery as measured by SPECT imaging, the Company believes that Generx could potentially be developed as a cost effective front-line therapy for patients with coronary artery disease in the large markets of newly-industrializing countries who often do not have access to costly procedures such as bypass surgery.  Having such additional clinical evidence confirming the safety and effectiveness of Generx for improving coronary collateral circulation in men and women with severe coronary artery disease could also potentially be used to optimize and broaden commercial development pathways in the U.S. and other major markets such as Europe.

"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.

Clinical Research Findings

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.

The Generx Phase 2b U.S. and Western European clinical studies evaluated the angiogenic effects of Generx using traditional ETT as the primary efficacy endpoint.  These studies demonstrated that Generx was safe and well tolerated by patients and a subgroup analysis undertaken by investigators (Henry TD, et al. J Am Coll Cardiol 2007; 50(11):1028-1046) concluded that older patients and patients with more advanced coronary artery disease (consisting largely of women) showed a dose-dependent and statistically significant response in a number of primary and secondary efficacy measures (at three and six months) that included improvement in exercise duration, time to onset of angina, as well as time to 1mm ST segment depression.

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

Generx (alferminogene tadenovec, Ad5FGF-4) is a DNA-based angiogenic growth factor therapeutic product candidate representing a new class of cardiovascular biologics as a 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.  Generx has progressed through four randomized, placebo controlled clinical studies at over 100 medical centers in the United States and Western Europe that have enrolled over 650 patients.  

About bioRASI

bioRASI is a full service global CRO that collaborates with the leading biotech and pharmaceutical companies in the clinical development of novel and generic therapeutics. bioRASI services include program management, regulatory, clinical, data management and analysis, compliance and audit.  bioRASI leverages its access to world renowned researchers and facilities in the U.S., Europe and Asia, to achieve unparalleled scientific, clinical and business results at significantly lower costs.  bioRASI is headquartered in Hollywood, FL and has offices in Miami, Los Angeles, San Diego, Wilmington, NC and overseas in Moscow, Kiev, Belgrade, Riga and Mumbai.  Information about bioRASI is available at www.biorasi.com.

About Cardium

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.  Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications.  In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio.  News from Cardium is located at www.cardiumthx.com.

Forward-Looking Statements

Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations.  For example, there can be no assurance that Generx can be successfully advanced in clinical studies outside of the U.S.; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that improvements in the formulation or use of Generx will be commercially practicable, or that Generx could be successfully advanced as a therapeutic in developing markets or that the results of studies in such markets could be used to advance or broaden the commercialization of Generx in the U.S. or other markets; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.

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.

SOURCE Cardium Therapeutics