Printer Friendly
The Free Library
19,607,059 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Corautus Genetics Inc. Announces FDA Approval for Commencement of Its Phase IIB Clinical Trial for Severe Cardiovascular Disease.


ATLANTA -- Corautus Genetics Inc. (AMEX AMEX

See: American Stock Exchange
: CAQ) announces that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has approved the commencement of its Phase IIB clinical trial for the treatment of severe cardiovascular disease.

The trial, as previously announced, will be a national, randomized, double-blinded, dose ranging and placebo controlled study of up to 404 patients in up to 20 centers in the United States evaluating the efficacy and safety of defined doses of Vascular Endothelial Growth Factor-2 (VEGF-2) to be percutaneously delivered via Boston Scientific Corporation's (NYSE NYSE

See: New York Stock Exchange
: BSX) Stiletto(TM) endocardial endocardial /en·do·car·di·al/ (-kahr´de-al)
1. situated or occurring within the heart.

2. pertaining to the endocardium.


endocardial

1. situated or occurring within the heart.

2.
 direct injection catheter. The trial will enroll qualified patients with Class III or IV angina. Patient enrollment is expected to commence during the third quarter.

Richard E. Otto, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , of Corautus stated, "Obtaining FDA approval to commence our Phase IIB clinical trial is an important milestone for Corautus. We have worked diligently with Boston Scientific to design a study to assess the effectiveness and safety of our therapeutic and the delivery system to promote angiogenesis in the heart and we are pleased that we can proceed to finalize documentation and begin the patient enrollment process."

About Corautus Genetics Inc.

Corautus Genetics Inc. is a clinical stage biopharmaceutical company dedicated to the development of gene transfer therapy products for the treatment of severe cardiovascular and peripheral vascular disease Peripheral Vascular Disease Definition

Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms.
. Corautus is currently developing and testing a gene transfer product using the Vascular Endothelial Growth Factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature).  2 (VEGF-2) gene to promote therapeutic angiogenesis in ischemic Ischemic
An inadequate supply of blood to a part of the body, caused by partial or total blockage of an artery.

Mentioned in: Antiangiogenic Therapy, Subarachnoid Hemorrhage, Ventricular Fibrillation


ischemic
 muscle. In July 2003, Corautus entered into a strategic alliance with Boston Scientific Corporation to develop, commercialize and distribute the VEGF-2 gene therapy products. For more information, please visit: www.corautus.com.

Forward Looking Statement

This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such statements are subject to certain factors, risks and uncertainties that may cause actual results, events and performances to differ materially from those referred to in such statements. These risks include statements which address operating performance, events or developments that we expect or anticipate will occur in the future, such as projections about our future results of operations or our financial condition, benefits from the alliance with Boston Scientific, research, development and commercialization of our product candidates, anticipated trends in our business, manufacture of sufficient and acceptable quantities of our proposed products, approval of our product candidates, meeting additional capital requirements, and other risks that could cause actual results to differ materially. These risks are discussed in Corautus Genetics Inc.'s Securities and Exchange Commission filings, including, but not limited to, the risk factors in Corautus' Annual Report on Form 10-K for the year ended December 31, 2003 (File No. 001-15833) filed March 30, 2004, which are incorporated by reference into this press release.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Jul 15, 2004
Words:467
Previous Article:Frost & Sullivan Honors Aspen Technology with 2004 Customer Value Enhancement Award.
Next Article:Sony Ericsson Extends EDGE-Offering with Two New Camera Phones.
Topics:



Related Articles
Corautus Genetics Inc. Names Officers and Senior Management Team.
Corautus Genetics Inc. Announces Reverse Stock Split and Plans for Private Financing.
Corautus Genetics Inc. Announces Conversion of Series A Preferred Stock and Effective Date of Reverse Stock Split as March 10, 2003.
Corautus Genetics Expands Management Team in Preparation for Phase IIb Clinical Trial.
Corautus Genetics Closes on $2.5 Million Loan Facility; Boston Scientific Agrees To Accelerate Payment of Loan Commitment Citing Progress in Clinical...
Corautus Genetics Announces First Quarter 2004 Financial Results.
Corautus Genetics Closes on $5 Million Loan Facility.
AVEXA IN-LICENSES PHASE II HIV DRUG FROM SHIRE.
An overview of the drug development process.
UCB INITIATES ADDITIONAL SHORT-TERM CLINICAL STUDY OF CIMZIA.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles