19.05.2014 17:35:00
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Cardio3 BioSciences Signs First Sales Contract for C-Cathez®
Regulatory News:
Cardio3 Biosciences (C3BS) (Paris:CARD) (Brussels:CARD), a leader in the discovery and development of advanced regenerative therapies for heart disease, announces today that it has entered into a trade agreement with ViroMed Co., LTD for the use of Cardio3 BioSciences’ catheter C-Cathez® in the development of ViroMed’s VM202-CAD product in Korea. Financial terms were not disclosed.
VM202-CAD is ViroMed's gene therapy-based medicine aimed at the treatment of ischemic cardiovascular diseases via therapeutic angiogenesis. Therapeutic angiogenesis represents a novel strategy for the treatment of cardiovascular disease through the formation of new blood vessels when the therapeutic is injected into ischemic sites. A Phase I clinical study for VM202-CAD has been completed in Korea and a phase II clinical study is planned for Q4 2014.
C-Cathez® is C3BS’ steerable percutaneous catheter. With its nitinol-based curved needle and side holes, this new generation of percutaneous injection catheter for myocardial delivery has been designed and developed to elevate the standard of care to clinicians and patients by focusing on three key features: local drug concentration, safety, and ease of use.
With C-Cathez®, Cardio3 BioSciences provides the clinician with a catheter which can be safely steered to reach target sites within the heart left ventricle. C-Cathez® permits stable contact with the beating myocardium without generating additional tissue trauma and diffuses the therapeutic agent over a bigger target area to obtain both a higher concentration and a wider tissue exposure.
Dr Christian Homsy, CEO of Cardio3 BioSciences, comments: "We are very glad to be able to contribute to the development of a potential new drug that aims to improve the standard of care for patients with coronary artery disease (CAD), a leading cause of death in developed countries. This is our first commercial agreement to supply C-Cathez® and we believe it emphasizes the potential C-Cathez® has to become a uniquely valuable tool for use with a wide array of biologics."
Yongsoo Kim, President and CEO of ViroMed adds: "Our VM202-CAD is a novel biologic that has the potential to go beyond the limits of current treatments for ischemic cardiovascular diseases by tackling the underlying causes. Using the superbly crafted C-Cathez® catheter in our upcoming phase II clinical study in Korea represents an important step in building the clinical evidence for our new approach to the treatment of these diseases.”
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About ViroMed
ViroMed Co., Ltd. is a biotechnology company listed on KOSDAQ and located in Seoul, Korea, focusing on gene and protein-based therapeutics for various diseases. ViroMed now has four lead products in development targeting cardiovascular disease, cancer, and genetic disease. To learn more about the company and its products, visit www.viromed.co.kr.
About VM202
VM202 is a gene therapy based drug that expresses a protein called HGF when intramuscularly injected into the patient. This protein is responsible for inducing angiogenesis (formation of new blood vessels) and regeneration of damaged nerve cells, which are the primary functions exploited. VM202 is currently being developed in clinical stages for ischemic cardiovascular disease and neurodegenerative diseases. Phase II clinical study in the US for critical limb ischemia (CLI) was successfully completed while phase II clinical study in China for CLI is ongoing. The follow-up stage of phase II clinical study in the US for diabetic peripheral neuropathy (DPN) was completed in March. ViroMed has also started patient enrollment for phase I/II clinical study in the US of amyotrophic lateral sclerosis (ALS), more commonly known as Lou Gehrig’s disease.
About Cardio3 BioSciences
Cardio3 BioSciences is a Belgian leading biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007 and is based in the Walloon region of Belgium. Cardio3 BioSciences leverages research collaborations in the US and in Europe with Mayo Clinic and the Cardiovascular Centre Aalst, Belgium.
The Company’s lead product candidate C-Cure® is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure® consists of a patient’s own cells that are harvested from the patient’s bone marrow and engineered to regenerate the heart. This process is known as Cardiopoiesis.
Cardio3 BioSciences has also developed C-Cathez®, the most technologically advanced injection catheter with superior efficiency of delivery of bio therapeutic agents into the myocardium.
Cardio3 BioSciences’ shares are listed on NYSE Euronext Brussels and NYSE Euronext Paris under the ticker symbol CARD.
C3BS-CQR-1, C-Cure, C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. Mayo Clinic holds equity in Cardio3 BioSciences as a result of intellectual property licensed to the company. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities.

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