Saturday, April 12, 2008

Cardium's Generx Advances To Phase 3 Following Meeting With FDA




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Acceleration of Generx from a deliberate Phase 2b confirmatory be trained to a Phase 3 provision claimant be base by the squad of grades from a by-patient meta-analysis of pooled rumour from the AGENT-3 and AGENT-4 study, which be review with the FDA. Generx represent a alien cathartic assortment of biologics designed to encourage angiogenesis, a raw method of capillary melanoma within the heart muscle, following a one-time intracoronary guidance from a ruling cardiac infusion catheter.



"Generx is the impulsive and individual DNA-based cardiovascular therapeutic to be advanced to Phase 3, and is believed to be the only sharing Phase 3 product candidate for the potential treatment of not clear angina, a confirmed medical position affecting millions of patients in the U.S. and elsewhere," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.



About BYETTA BYETTA be the preparatory in a investigational class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibit plenteous of like effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in comeback to stores intake, have multiple effects antagonistic the intestine, liver, pancreas and psyche that sweat in concert to correct blood sugar.(1) About Incretin Mimetics Incretin mimetics is a new class of treatment in the brawl against diabetes. An incretin mimetic works to take off the anti-diabetic or glucose-lowering endeavours of essentially occurring human hormones called incretins. These actions think over put on ice the body's fitness to make insulin in response to elevated level of blood sugar, inhibit the unlock of a hormone called glucagon subsequent meal, slow the rate at which nutrients are spellbound into the bloodstream and reducing food intake. BYETTA is the first FDA-approved agent of this new class of medications.



Following pondering with FDA, improvements in myocardial blood flow within the studied heart muscle will also be measured exactly by SPECT perfusion imaging (single photon energy total tomography) as a secondary efficacy endpoint. SPECT perfusion was the focus of the AGENT-2 despondent parts of achievement study (Grines et al., J AM Coll Cardiol 2003; 42:1339-47).



Improvements in myocardial blood flow observed in the AGENT-2 study, which incorporated both man and women, were equal in vastness to improvements story in the literature for patients who own undergone revascularization procedures (coronary artery bypass graft surgery or angioplasty).



This Phase 3 clinical study (AWARE), which is anticipated to be going ahead in the first quarter of 2007, will be a randomized, placebo-controlled, double-blind trial in almost 300 women at multiple medical centers in the U.S. An extramural continuation study of Generx in men with repeated angina in the red to myocardial ischemia is expected to commence following. Cardium's therapeutic view to the treatment of cardiovascular heart virus have be the focus of the best widely-conducted clinical studies for Angiogenic Gene Therapy (AGENT-1 through AGENT-4), which to date have an assortment of wakeful 663 patients at beyond one hundred U.S., European and other medical centers.



The AWARE Study The Company's AWARE (Angiogenesis in Women with Angina pectoris who are not candidate for REvascularization) clinical trial will measure capable of the therapeutic effects of Generx in women with myocardial ischemia, which is associated with coronary heart disease and angina. An abrasive six million American women are at present mindful with coronary heart disease and more than three million women suffer from angina. The American Heart Association reports that more women's live are contention annually by cardiovascular disease than by the subsequent five through rationale of demise joint (all cancer, chronic obstructive pulmonary disease (COPD), Alzheimer's, diabetes and accidents). Despite these stark statistics, opinion poll indicate that nearly somewhat of women are not aware that heart disease is the leading cause of death among women, and only 20 percent identified heart disease as the best robustness hang-up facing women today. Observed difference relating men and women with coronary heart disease are not fully couched. Some researchers fathom out the differences may be the end result of microvascular disease, the narrowing or stiffen of the smaller sum significant artery and arterioles that provide for the heart. While microvascular disease is believed to affect both men and women with coronary heart disease, the hold is on the disguise somewhat abstruse in women and in patients with diabetes.



About Generx Generx(TM) (alferminogene tadenovec) is the head product candidate in a new class of cardiovascular biologics sensationally someone programmed to leverage the body's natural therapeutic process in comeback to unyielding ischemic hassle (insufficient blood flow and myocardial oxygen deliver due to coronary heart disease). The natural biologic response to repeated transient ischemia is angiogenesis, the growth of new collateral blood vessel, which is orchestrate by a complex and incompletely understood falls involving oodles myocardial-derived growth factor. These newly-formed vessels can effectively pass on vessel into place blood flow and oxygen carrying to parts of the patient's heart downstream from a bottleneck in a coronary artery. In many patients on the other hand, moreover as those with recurrent angina, coronary collateral vessel foundation is destitute behind you upon the heart's wishes during stress. Currently free anti-anginal drugs, which may furnish suggestive relief, are largely designed to alter the oxygen necessity of the heart muscle or dilate vessels to temporarily divulge angina. Generx is an angiogenic therapeutic that is designed to promote the heart's natural response of collateral growth and to print blood flow in the microcirculation.



About Cardium Cardium Therapeutics, Inc. and its subsidiary, InnerCool Therapies and the Tissue Repair Company, are medical technology company predominantly approved on the fruition, deception and mart of revolutionary therapeutic products and devices for cardiovascular, ischemic and related indication. In October 2005, Cardium acquire a portfolio of growth factor therapeutics from the Schering AG Group, Germany, including the later-stage product candidate, Generx(TM), and completed a $30 million finance. Generx (alferminogene tadenovec) is a DNA-based growth factor therapeutic being developed for potential operation by interventional cardiologists as a one-time treatment to promote and fuel the growth of collateral circulation in the heart of patients with ischemic terms such as recurrent angina. For more information about Cardium and its business, products and therapeutic candidates, delight call round or estimation its booklet at /flash/pdf/CardiumTHX_Brochure.pdf.



In March 2006, Cardium acquired the technology and products of InnerCool Therapies, Inc., a San Diego-based medical technology amity in the emerging pasture of therapeutic hypothermia, which is designed to hurriedly and controllably put on ice the article spick and span to diminish cell death and pander to following acute ischemic business such as cardiac art or constrict, and to potentially lessen or avert associated blister such as adverse neurological outcome. For more information about Cardium's InnerCool subsidiary and therapeutic hypothermia, including its Celsius Control System(TM), which has now received regulatory clearance in the U.S., Europe and Australia, please visit In August 2006, Cardium acquired the technologies and products of the Tissue Repair Company (TRC), a San Diego-based biopharmaceutical company focused on the development of growth factor therapeutics for the treatment of rigorous chronic diabetic harm. TRC's lead product candidate, Excellarate, is a DNA-activated collagen gel for topical treatment formulate with an adenovector delivery holder encoding human platelet-derived growth factor-B (PDGF-B). Excellarate is to start rotten with being developed to be administered once or twofold for the potential treatment of non-healing diabetic foot ulcer. Other potential standing for TRC's Gene Activated Matrix(TM) (GAM) technology encompass therapeutic angiogenesis (cardiovascular ischemia, at a tangent arterial disease) and orthopedic products, including firm tissue (bone) and flesh (ligament, muscle, cartilage). For more information about Cardium's Tissue Repair Company subsidiary, please visit Forward-Looking Statements Except for message of historical decision, the matter discuss here embrace rescue are forward look and peal numerous supposition and mess up with a sort of speculate and uncertainties, many of which are over and done our control and may cause actual results to assessment materially from stated expectations. For suitcase, in being there can be no promise that results or trend observed in one clinical study will be reproduce in a subsequent study or studies, that planned clinical trial can be initiate in a timely deportment or perform successfully, that clinical trials and other hard work to get faster the development of our Generx(TM) product candidate will be exultant, that enforced regulatory approvals will be acquire, that our actual or proposed products and treatment will prove to be undisruptive or potent, that third entertainment on whom we depend will take out as anticipated, that our products or product candidates will lead to pro enhancing or partner opportunity, that opposing products will not be safer, more effective or less pricey, or that we will purloin the place of in enhancing long-term shareholder value. Actual results may also differ substantially from those describe in or contemplate by this press release due to risks and uncertainties that subsist in our operation and commercial environment, including, lacking restriction, our approved submit yourself to in the development of DNA-based cardiovascular therapeutics and therapeutic hypothermia devices, our entail upon proprietary technology, our times of yore of operating losses and accumulate deficit, our idea on collaborative interaction and fussy personnel, and current and forthcoming contention, as well as other risks described on moment in filings we kind with the Securities and Exchange Commission. We attempt no sphere of amusement to release publicly the results of any revisions to these forward-looking statements to reflect events or location arise after the date hereof.



Copyright 2006 Cardium Therapeutics, Inc. All rights kept posterior. For Terms of Use Privacy Policy, please visit Cardium Therapeutics(TM) and Generx(TM) are trademark of Cardium Therapeutics, Inc.



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Cardium Therapeutics, Inc




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