Cardium Therapeut. ( WKN: A0H058 / CXM ) /AMEX
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HOMEPAGE: www.cardiumthx.com/
Cardium Therapeutics, Inc. focuses on the acquisition and development of innovative bio-medical product opportunities and businesses that have the potential to address unmet medical needs and definable pathways to commercialization, partnering, and other economic monetizations. The companys investment portfolio includes the Tissue Repair Company and Cardium Biologics, which are medical technology companies primarily focused on the development of innovative therapeutic products for tissue repair and cardiovascular indications. Its products include Generx, a DNA-based growth factor therapeutic that is in Phase III clinical stage designed to leverage the bodys natural healing processes in response to repeated ischemic stress; Corgentin, a pre-clinical stage product, which enhances myocardial healing in and around the infarct zone when used as an adjunct to existing vascular-directed pharmacologic and interventional therapies; and Excellarate, a tissue repairs product candidate that is in Phase IIb clinical trial for the treatment of non-healing diabetic foot ulcers. The company was founded in 2003 and is headquartered in San Diego, California.
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Cardium Announces Planned Release of Data from Matrix Excellarate Phase 2b Clinical Study and Acceptance of Phase 1 / 2 Study for Publication in Wound Repair and Regeneration
On Thursday October 1, 2009, 9:00 am EDT
http://finance.yahoo.com/news/...-prnews-1714688369.html?x=0&.v=1
SAN DIEGO, Oct. 1 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) announced plans to report on preliminary safety and efficacy data from its Matrix Phase 2b Excellarate clinical study. Based on guidance from Cardium's independent clinical data management company which is currently completing the statistical analysis of all data for the Matrix clinical trial, Cardium expects to receive the locked unblinded data set and be in position to announce preliminary results on or before October 14, 2009. The Company also plans to hold a webcast to review the clinical data, details of which will be provided with announcement of the Matrix clinical results.
Cardium also announced that positive results from the Phase 1 / 2 clinical study of Excellarate have been accepted for publication in Wound Repair and Regeneration, the peer-reviewed medical journal of the Wound Healing Society. The article, entitled Treatment of Nonhealing Diabetic Foot Ulcers with Platelet Derived Growth Factor Gene-Activated Matrix (GAM501): Results of a Phase 1/2 trial (Mulder, et al) is expected to be published and available online in early October 2009.
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 the Matrix study or other human clinical trials can be conducted and completed in an efficient and successful manner, that Excellarate or our other candidates will prove to be sufficiently safe and effective, that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, that clinical studies even if successful will lead to product advancement or partnering, 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.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved.
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* Press Release
* Source: Skymark Research
* On 9:00 am EDT, Friday October 9, 2009
http://finance.yahoo.com/news/...iates-pz-115358112.html?x=0&.v=1
http://www.t-r-co.com/pdfs/TRC_Webcast_051409.pdf
Cardium Reports Positive Data From Matrix Phase 2b Study of Excellarate(TM) Topical Gel for Non-Healing Diabetic Foot Ulcers and Plans for Phase 3 Program
Excellarate Offers Potential for Simpler and Enhanced Treatment Opportunities within the Spectrum of Advanced Wound Care Biologics, Bio-Engineered Dermal Substitutes and Medical Devices
* Press Release
* Source: Cardium Therapeutics
* On 9:00 am EDT, Wednesday October 14, 2009
http://finance.yahoo.com/news/...-prnews-3741923328.html?x=0&.v=1
Cardium Announces $6.0 Million Registered Direct Offering
Date : 10/15/2009 @ 9:15AM
Source : PR Newswire
http://ih.advfn.com/...55612718&article=39910497&symbol=A^CXM
SAN DIEGO, Oct. 15 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced a registered direct offering of common stock to selected investors for aggregate gross proceeds of $6.0 million. The offering is made pursuant to a registration statement that was filed by Cardium Therapeutics with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 15, 2007. Details concerning the terms of the financing and the warrants can be found in the Company's Current Report on Form 8-K to be filed with the SEC at http://www.sec.gov/.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
The securities in the offering include an estimated 4,615,385 shares of Cardium common stock at a price of $1.30 and warrants to purchase up to 3,000,000 shares of Cardium common stock at an exercise price of $1.40. The warrants are exercisable six months after the date of issuance, and will expire six years from the date they are first exercisable. Dawson James Securities acted as exclusive placement agent for the offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offer will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
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 tissue repair and cardiovascular indications. In October 2009, Cardium announced results for the Matrix Phase 2b clinical study of the Excellarate product candidate as a treatment for patients with non-healing diabetic ulcers. News from Cardium is located at http://www.cardiumthx.com/.
Positive Findings from Excellarate(TM) Phase 1/2 Clinical Study Published in Journal of Wound Repair and Regeneration
Date : 10/15/2009 @ 9:00AM
Source : PR Newswire
http://ih.advfn.com/...55612718&article=39910247&symbol=A^CXM
SAN DIEGO, Oct. 15 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced the publication of positive findings from the open label multi-center Phase 1/2 clinical study of Excellarate(TM) (GAM501, Ad5PDGF-B / 2.6% collagen), its product candidate for the potential treatment of non-healing diabetic foot ulcers. The clinical findings, entitled Treatment of Nonhealing Diabetic Foot Ulcers with a Platelet-Derived Growth Factor Gene-Activated Matrix (GAM501): Results of a Phase 1/2 trial (Mulder, et al), are to be published in the October 2009 issue of Wound Repair and Regeneration, a peer-reviewed medical journal of the Wound Healing Society. The publication is now available online at the following website: http://www3.interscience.wiley.com/journal/122648469/abstract.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
...weiter siehe LINK
Cardium Completes $6.0 Million Registered Direct Offering
http://www.finanznachrichten.de/...registered-direct-offering-008.htm
SAN DIEGO, Oct. 20 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced that it has completed its previously announced $6.0 million registered direct offering of common stock to selected investors. The transaction resulted in net proceeds to the company of $5.5 million after fees and expenses. The offering was made pursuant to a shelf registration statement that was filed by Cardium Therapeutics with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 15, 2007. Details concerning the terms of the financing and the warrants can be found in the Company's Current Report on Form 8-K filed with the SEC on October 15, 2009 at http://www.sec.gov/.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offer will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.
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 tissue repair and cardiovascular indications. In October 2009, Cardium announced results for the Matrix Phase 2b clinical study of the Excellarate product candidate as a treatment for patients with non-healing diabetic ulcers. News from Cardium is located at http://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 the MATRIX study or other human clinical trials can be conducted and completed in an efficient and successful manner, that product formulation enhancements will be successful or will effectively simplify or expand the use of product candidates or technologies, that the GAM technology can be successfully broadened or applied to additional wound healing or tissue repair opportunities, that Excellarate or our other candidates will prove to be sufficiently safe and effective, that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, that clinical studies even if successful will lead to product advancement or partnering, 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.
Copyright 2009 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) and Generx® are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellarate(TM) and Osteorate(TM) are trademarks of Tissue Repair Company.
Other trademarks are the property of their respective owners.
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Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web Site: http://www.cardiumthx.com/
Cardium Announces Plans to File FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Gel for Diabetic, Pressure and Venous Ulcers and Other Topical Wounds
SAN DIEGO, Nov. 2 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced plans to submit a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its ExcellagenXL(TM) product candidate. ExcellagenXL is an advanced wound care management medical device, which is a customized collagen-based topical gel designed for 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. The Company expects to submit its FDA 510(k) application for ExcellagenXL during the current quarter.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
The planned 510(k) filing is based in part on positive findings from the Company's Phase 2b Matrix clinical study, reported October 14, 2009, indicating that substantial improvements in wound healing responses were observed in patients with non-healing diabetic foot ulcers following one or two applications of ExcellagenXL. The ExcellagenXL topical gel wound care product is designed to promote a favorable environment for effective wound management by providing a moist protective barrier as well as a micro-scaffold that promotes cell migration and capillary in-growth.
ExcellagenXL is an advanced wound care device composed of highly-refined, soluble bovine dermal collagen (Type I), which is modified to reduce immunogenicity and promote its usefulness in wound settings. ExcellagenXL is planned for physician use in conjunction with standard of care wound therapy, which in the case of diabetic ulcers typically includes surgical debridement and off-loading. ExcellagenXL is expected to be indicated for use at two-week intervals (with weekly outer dressing changes) as an adjunct to surgical debridement, and supplied in a sterile single-use syringe along with a sterile flexible application needle to facilitate topical administration over the wound site. ExcellagenXL will be stored at standard refrigeration temperature (2 degrees C - 8 degrees C).
Cardium also announced plans to develop additional new product opportunities by incorporating other agents into Excellagen formulations, including antimicrobials, DNA and/or other biologics, which are designed to address particular wound healing and other tissue repair applications.
"We are pleased to announce plans to submit our FDA 510(k) premarket notification of our ExcellagenXL collagen-based topical gel. The 510(k) clearance process provides us with a potential near-term opportunity to introduce this product into the rapidly-growing market for advanced wound care. Applying our specialized formulation know-how and the unique properties of our collagen-based matrix technology, we also look forward to introducing additional Excellagen-based products in the near future," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
...(weiter siehe LINK)
Cardium Reports on Third Quarter 2009 Financial Results and Recent Developments
SAN DIEGO, Nov. 10 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported its financial results for its third quarter ended September 30, 2009, and on recent developments and future outlook. Cardium made significant progress since its second quarter 2009 financial report and highlights included:
-- Sale of Cardium's InnerCool Therapies business to Royal Philips Electronics;
-- Completion and announcement of data from the Matrix Phase 2b clinical trial of Excellarate(TM) for the potential treatment of non-healing diabetic ulcers and the Company's plans to meet with the FDA to review the data and proposed outline for a Phase 3 clinical study;
-- Plans for the commercial development of a new product candidate Excellagen(TM), 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;
-- Publication of positive findings from the open label multi-center Phase 1/2 Excellarate clinical study in the October 2009 issue of Wound Repair and Regeneration, a peer-reviewed journal of the Wound Healing Society;
-- 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;
-- Publication of preclinical research published in the scientific journal, Gene Therapy, demonstrating the potential benefits of the Cardium's Gene Activated Matrix technology for accelerating and enhancing periodontal tissue repair and oral implant osseointegration;
-- Completion of two registered direct investments of Cardium's common stock by institutional investors with gross proceeds totaling $10.5 million;
-- Listing compliance with the NYSE Amex.
...(weiter siehe LINK)
http://www.finanznachrichten.de/...ble-collagen-protein-based-008.htm
Cardium Files FDA 510(k) Application for U.S. Marketing Clearance of ExcellagenXL(TM) Topical Gel and ExcellagenFX(TM) Flowable Collagen Protein-Based Matrix for Diabetic, Pressure and Venous Ulcers and Other Dermal Wounds
SAN DIEGO, Dec. 3 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) announced today that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen(TM) product candidate based on positive data from the Company's recently completed Phase 2b Matrix clinical study. Today's submission with the FDA covers ExcellagenXL(TM) and ExcellagenFX(TM), advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for use by health care professionals for patients with dermal wounds, which can include diabetic ulcers, pressure ulcers, venous ulcers, tunneled/undermined wounds, surgical and trauma wounds, second degree burns, and other types of wounds.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
The 510(k) submission is based in part on positive findings from the Company's Phase 2b Matrix clinical study, reported on October 14, 2009, demonstrating substantial improvements in wound healing responses in patients with non-healing diabetic foot ulcers following one or two applications of Excellagen, an enhanced, customized collagen-based gel matrix. ExcellagenXL is designed for use by health care professionals in a clinical setting and as an adjunct to standard of care topical wound therapy, which in the case of diabetic ulcers typically includes surgical debridement and off-loading. The ExcellagenFX kit is designed for use by health care providers in a clinical setting in the treatment of larger soft tissue or tunneling wounds that may occur with pressure, venous and diabetic ulcers, and surgical wounds. The ExcellagenFX flowable matrix product allows for deeper administration and direct intimate contact with the wound bed in these more complex, irregular and difficult to access wounds.
Based on the unique properties of the highly purified and enhanced Type-I collagen protein used, Excellagen gel requires storage at standard refrigeration temperatures (2°C - 8°C) and will be packaged in sterile, pre-filled single-use syringes for topical administration by health care professionals. Other categories of advanced wound care products are manufactured with alginates, hydrogels and hydrocolloids in structured, membrane or granular product configurations, or require hydration, mixing and reconstitution immediately prior to patient administration. The Company's Excellagen fibrillar collagen protein gel is a physiologic formulation consisting of a bioactive and biodegradable material that promotes effective wound management by providing a moist protective barrier and stimulates the natural wound healing process through the promotion of cell migration and capillary in-growth to support tissue regeneration.
ExcellagenXL is currently planned for use at one- to two-week intervals (with weekly outer dressing changes) and as an adjunct to surgical debridement. ExcellagenXL will be supplied in a kit configuration containing four single-use 1.0 cc syringes, each containing 0.5 cc of Excellagen gel, and four sterile flexible applicators to facilitate topical administration over the wound site. The ExcellagenFX kit will consist of one single-use 10.0 cc syringe containing 4.0 cc of Excellagen gel, and one single-use sterile flexible applicator designed for deeper administration at the wound site and is planned for use in more complex and difficult to access deep soft tissue wounds.
"The submission of our FDA 510(k) premarket notification for Excellagen collagen protein-based product candidate for topical administration to partial and full-thickness wounds represents an important first step forward in the commercialization of our Excellagen technology platform. Our advanced wound healing technology platform also involves Cardium's Gene Activated Matrix technology which covers DNA-based wound healing, as well as DNA-based orthobiologics. The Excellagen product platform provides us with a more near-term opportunity to introduce these products into the large and rapidly-growing market for advanced wound care. As recently reported, we plan to develop and introduce additional new product opportunities by incorporating other agents into the Excellagen formulation, including antimicrobials, DNA and/or other biologics, which will be designed to address particular wound healing and other tissue repair applications," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
(...weiter siehe LINK)
http://phx.corporate-ir.net/...M4MzJ8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1
Date : 01/05/2010 @ 9:15AM
Source : PR Newswire
Stock : (CXM)
http://ih.advfn.com/...?pid=nmona&article=40968234&symbol=CXM
http://www.finanznachrichten.de/...10-cell-gene-therapy-forum-008.htm
Cardium Provides Update on Commercial Development Plans for Generx Angiogenic Therapy for Heart Disease at 2010 Cell & Gene Therapy Forum
SAN DIEGO, Jan. 26 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) reported today that its Cardium Biologics division provided an update on plans for the continuing commercial development of Generx(TM) (alferminogene tadenovec, Ad5FGF-4), a DNA-based angiogenic therapy product candidate for patients with coronary artery disease. The update was presented by Gabor M. Rubanyi, M.D., Ph.D., Cardium's Chief Scientific Officer at the annual 2010 Cell&Gene Therapy Forum in Washington, D.C. on January 25, 2010. An investor presentation that includes material from Dr. Rubanyi's presentation is now available on Cardium's website at http://phx.corporate-ir.net/...html?c=77949&p=irol-presentations.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) Cardium Biologics reported on the following findings and plans:
(1) As previously announced, based on an agreement with the FDA, Generx would be re-formulated to increase its shelf life, and further formulation enhancements are expected to allow for storage using a standard freezer (rather than at -70 degrees C), and potentially a lyophilized version for refrigerated storage.
(2) Based on clinical and pre-clinical findings, angiogenic therapy appears to lead to long-term functional improvements in cardiac microvascular circulation, and Cardium believes that cardiac perfusion (as measured by SPECT) appears to be an important efficacy endpoint to consider that is now supported by a 10-year study of the cardio-protective nature of collateral circulation (Meier et al. Circulation 2007; 116:975-83).
(3) Recent preclinical data developed by the Company under an SBIR grant indicate that localized ischemia can significantly increase Ad5 transfection in the heart in association with intracoronary infusion therapy, suggesting that cardiac stimulation (using e.g. dobutamine which is routinely administered to patients) in association with administration of Generx has the potential to dramatically enhance the therapeutic effect at a given dose.
(4) In order to incorporate these enhanced formulations and perspectives and also expand the clinical database supporting the potential commercialization of Generx, the Company 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). The U.S. and European clinical studies of Generx have collectively established an extensive database supporting the safety of this product candidate, even in patients with severe forms of chronic coronary artery disease. Successful application of this therapy as "front-line care" would be expected to lead to commercialization pathways in many developing markets for which surgical and other relatively expensive approaches are either unavailable or limited by already over-burdened health care systems. In addition, information gained with these new applications would be expected to be useful to support broadened commercialization pathways in the U.S. and other developed markets.
"There has been significant progress in the care and treatment of patients with cardiovascular disease in the industrialized world, although at considerable and increasing expense. While heart disease remains a very serious problem in the U.S. and Europe, incidence is rapidly increasing in large parts of the newly-industrializing world such as China, India and Russia, as well as in the Middle East and Latin America. In many countries, healthcare systems are unable to provide wide access to relatively expensive procedures such as coronary angioplasty, stenting, or cardiac bypass surgery. Based on data indicating that the Generx product candidate appears to safe and has the potential to substantially increase coronary blood flow in the context of heart disease - coupled with recent findings that improvements in collateral circulation are associated with long-term benefits, including reduced mortality as reported in a 10-year study published in Circulation - we believe that this product candidate could be developed as a front-line therapy for coronary artery disease. 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," stated Christopher J. Reinhard, Cardium Chairman and Chief Executive Officer.
Mechanism of Action Study: Generx Improves Blood Flow via Increased Collateral Circulation in Ischemic Heart Tissue
Reported in Journal of American College of Cardiology
Positive results supporting the proposed mechanism of action of Generx in improving blood flow within ischemic heart tissue were published in JACC, A Randomized, Double-Blind, Placebo-Controlled Trial of Ad5FGF-4 Gene Therapy and its Effect on Myocardial Perfusion in Patients with Stable Angina (Grines et al., J Am Coll Cardiol 2003; 42:1339-47). The results of the study showed improvements in myocardial perfusion (blood flow) in the ischemic region of the hearts of both men and women following a single intracoronary infusion of Generx. Increases in blood flow within the ischemic regions of the heart under the conditions studied (i.e., adenosine infusion) are believed to be due to the formation of new collateral blood vessels capable of providing additional blood flow capacity under stress. Generx was well tolerated in the study of 52 patients (88% men and 22% women) with reversible ischemia of >9%, with no adverse sequelae. 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). The observed treatment effect for patients receiving Generx was similar in magnitude to that reported in the literature for patients undergoing revascularization procedures (CABG surgery or angioplasty) with reversible perfusion defects of comparable size at one year following these procedures.
Long-term Independent Study Demonstrates that Collateral Circulation has an Important Protective Role in Chronic Angina Patients and Reduces Cardiovascular and All-Cause Mortality as reported in American Heart Association Journal Circulation
A long-term study published in the American Heart Association's Journal, 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 demonstrated that long-term cardiac mortality was reduced by 75% in patients with a highly developed collateral vessel blood supply (p=0.0395). This study provides new evidence suggesting that patients with more coronary collateral vessel growth have a better chance of surviving a heart attack than patients who have less developed collateral vessel growth.
It is well known that transient myocardial ischemia in certain patients with coronary artery disease will stimulate the growth of collateral vasculature and that the extent of pre-existing collateral circulation in patients appears to influence survival after a heart attack by providing alternate routes for myocardial blood flow. While not well understood, patients' inherent capacity to grow this micro-vasculature may be limited due to factors such as the course and progression of their coronary artery disease and their genetic predisposition. This study provides quantitative evidence suggesting that collateral blood flow may improve the prognosis of patients undergoing angioplasty or bypass surgery. Detectable collateral vessel function following angioplasty has been reported, even in patients without evidence of ischemia.
Generx Product Candidate
The Generx(TM) (alferminogene tadenovec, Ad5FGF-4) product candidate represents a new class of cardiovascular biologics that is being developed to leverage the body's natural healing processes in response to repeated ischemic stress (insufficient blood flow and myocardial oxygen supply due to coronary heart disease). The natural biologic response to repeated transient ischemia is angiogenesis, the growth of new collateral blood vessels, which is orchestrated by a complex and incompletely understood cascade involving many growth factors. These newly-formed vessels can effectively augment blood flow and oxygen delivery to areas of the patient's heart downstream from a blockage in a coronary artery. In many patients however, including those with recurrent angina, coronary collateral vessel formation is insufficient to meet the heart's needs during stress. Currently available anti-anginal drugs, which may provide symptomatic relief, are generally designed to alter the oxygen demand of the heart muscle or dilate vessels to temporarily relieve angina. Generx is an angiogenic therapeutic that is designed to promote the heart's natural response of collateral growth and to increase blood flow in the microcirculation. In contrast to the transient symptomatic relief provided by marketed anti-anginal medicines, usually taken several times a day for years, a single administration of Generx aims at modifying the disease by permanent or long-lasting structural changes in the heart.
Researchers believe that central to the biological activity of Generx is the effective capture of the Ad5 delivery vector in the coronary micro-vascular circulation, subsequent vector uptake, and FGF-4 protein expression in the heart (preferentially myocytes and endothelial cells). The new preclinical studies show that ischemia is a prerequisite for efficient delivery and transfection of Ad5FGF-4 in the heart. The formation of new blood vessels (angiogenesis) and remodeling of existing collateral vessels are the two main mechanisms contributing to the therapeutic effect of an angiogenic growth factor. New micro-vascular circulation development naturally occurs in the embryo, but in the adult organism it requires tissue injury (such as ischemia) to initiate a regenerative process, including collateral vessel formation. Research shows that FGF-4 is an important regulatory protein in the pathway that orchestrates the growth of new micro-vascular vessels and their enlargement in the heart. After the FGF-4 protein is secreted or transported out of the myocyte, it acts via high affinity FGF receptors on neighboring endothelial cells to signal the initiation of cardiac angiogenic activity and enhancement of the collateral vessel formation process.
These actions of FGF-4 require an ischemic/hypoxic milieu to proceed efficiently. FGF-stimulation may promote the formation of more mature vessels with improved stability, which, combined with appropriate blood flow through them, should contribute to the long term persistence of newly formed collateral vessels. Once the beneficial blood vessel growth or vascular remodeling has been accomplished, and provided there is sustained blood flow through the newly-formed vessels, continued FGF-4 growth factor secretion is no longer needed. Indeed, preclinical studies demonstrated that a single intracoronary infusion of Generx was capable of stimulating new vessel formation in the heart that was associated with improved blood flow and ventricular contractile function, an effect which lasted for at least 3 months.
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 http://www.cardiumthx.com/.
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http://www.finanznachrichten.de/...f-generx-product-candidate-008.htm
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.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
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 http://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 http://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.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/. Cardium Therapeutics(TM) and Generx(R) and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc. Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM) are trademarks of Tissue Repair Company.
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Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations, of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web Site: http://www.cardiumthx.com/
http://www.biorasi.com/
© 2010 PR Newswire
Meldung kam noch keine übrigens von der FDA
Tissue Repair Company is a subsidiary of Cardium Therapeutics, Inc. (NYSE Amex:CXM). The former already submitted a 510(K) premarket notification application to the United States of America’s Food & Drug Administration (FDA). The 510(K) submission was made to get the regulator’s approval to bring Excellagen™ into the market. According to the company, it contains favorable data from the second stage of the Phase 2 Matrix clinical trial – which the company had lately conducted. The submission includes information on both the ExcellagenXL™ and ExcellagenFX™ – two medical devices of the same product line. On December 3, 20009, Cardium announced that the FDA is expected to decide whether Excellagen could be marketed or not within March 3, 2010.
Both ExcellagenXL and ExcellagenFX contain topical gels – that are made of Type 1 collagen proteins. These gels help in healing skin wounds – such as second degree burns, wounds caused by surgery or shock, ulcers causing by diabetes or pressure, and venous ulcers. Both of the medical devices must be used by licensed physicians and in clinical settings.
The collagen proteins have been purified intensively and thus have powerful effects. The gel must be stored under low temperatures – more specifically, at 2°C – 8°C. If they are marketed, they would be sold in sterile packages (most probably, in one-time syringes) so that they can easily be used by physicians.
After the news of the FDA acceptance was released, Christopher J. Reinhard, who is the CEO and also the Chairman of Cardium, discussed about the company’s future plans:
“Our advanced wound healing technology platform also involves Cardium’s Gene Activated Matrix technology which covers DNA-based wound healing, as well as DNA-based orthobiologics. The Excellagen product platform provides us with a more near-term opportunity to introduce these products into the large and rapidly-growing market for advanced wound care. As recently reported, we plan to develop and introduce additional new product opportunities by incorporating other agents into the Excellagen formulation, including antimicrobials, DNA and/or other biologics, which will be designed to address particular wound healing and other tissue repair applications”.
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http://www.finanznachrichten.de/...0-bright-lights-conference-008.htm
Cardium to Present at MDB Capital Group's 2010 Bright Lights Conference
SAN DIEGO, May 7 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) has been invited to present at the 2010 MDB Capital Group's Bright Lights Conference. The conference will be held May 10-12, 2010 at the Palace Hotel in San Francisco.
(Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
Cardium's Chairman and Chief Executive Officer, Christopher J. Reinhard is presenting on Tuesday, May 11, 2010 and a copy of the presentation is available at the Investors section of Cardium's website at http://phx.corporate-ir.net/...html?c=77949&p=irol-presentations.
The inaugural Bright Lights Conference will showcase 50 of the most innovative public companies ranked in the 90th percentile for technology leadership. The presenters were chosen from over 1,600 small cap companies with U.S. patents, as rated by PatentVest, MDB Capital Group's proprietary IP business intelligence database. The conference will include company presentations, expert panels, IP workshops and one-on-one investor meetings. Additionally, MDB Capital Group will provide analysis and objective data regarding the technology leadership and competitive landscape of the companies presenting during this exclusive, invitation-only event. For more information about the conference, visit http://www.mdb.com/bright-lights-conference.html.
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 http://www.cardiumthx.com/.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) and Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM) are trademarks of Tissue Repair Company.
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Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web Site: http://www.cardiumthx.com/
© 2010 PR Newswire
Cardium Bright Lights Conference Presentation - May 2010
05/11/10
http://phx.corporate-ir.net
*amM - keine Kaufempfehlung
09.09.2010 15:30
http://www.finanznachrichten.de/...annual-healthcare-investment-confe
SAN DIEGO, Sept. 9 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) announced today that Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer will present at the Rodman&Renshaw 12th Annual Healthcare Investment Conference on September 14, 2010 at 4:55 p.m. Eastern Time. The conference, which will feature more than 500 presenting companies and 3,500 attendees, is being held September 12-15, 2010 at the New York Palace Hotel in New York. A webcast of the Company's presentation will be available live and by replay and can be accessed at http://www.wsw.com/webcast/rrshq18/cxm/ or the Investors section of Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-calendar. The investor presentation slides are available and can be viewed at http://phx.corporate-ir.net/...html?c=77949&p=irol-presentations.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) 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 http://www.cardiumthx.com/.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/. Cardium Therapeutics(TM) and Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc. Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM) and Osteorate(TM)are trademarks of Tissue Repair Company.
Photo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org/
http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
PRN Photo Desk, photodesk@prnewswire.com
Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web Site: http://www.cardiumthx.com/
© 2010 PR Newswire
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