Corautus Genetics' Phase IIb GENASIS Clinical Trial Receives Recommendation to Proceed From Data Monitoring Committee
Posted on: Wednesday, 30 March 2005, 09:00 CST
ATLANTA, March 30 /PRNewswire-FirstCall/ -- Corautus Genetics Inc. announced today that as the result of its scheduled interim safety analysis, the independent data monitoring committee (DMC) recommended the continuation of GENASIS ("Genetic Angiogenic Stimulation Investigational Study"), Corautus' Phase IIb clinical trial to evaluate the safety and efficacy of Vascular Endothelial Growth Factor-2 (VEGF-2) for the treatment of patients with severe angina.
The planned interim safety analysis was conducted after the first 54 patients were treated in the trial. The DMC is comprised of independent physicians and a statistician and was established to monitor the safety data from the trial. Based upon their review of the available data, the DMC recommended continuing the GENASIS trial.
Dr. Douglas W. Losordo, Chief, Cardiovascular Research, Caritas St. Elizabeth's Medical Center, Boston and the national principal investigator for the GENASIS trial commented, "The real story being developed by the GENASIS trial is that it will generate the largest single trial accumulation of data regarding intramyocardial gene transfer. We have seen promising data from the earlier clinical studies and are extremely pleased that the current trial is proceeding as planned."
Richard E. Otto, President and CEO of Corautus, stated, "The GENASIS trial has been designed to test the efficacy and safety of VEGF-2, which is delivered via the Stiletto(TM) catheter developed by Boston Scientific Corporation. Corautus developed a well-defined schedule to deliver data for the first interim safety analysis by the independent DMC. We completed that task and are pleased with the recommendation of the DMC to continue the trial. There is an important unmet medical need to treat patients suffering from severe angina where traditional methods have been unsuccessful, and we are working diligently to conduct our trial in the safest and most efficient manner possible to help these patients."
The American Heart Association estimates that more than 6.4 million individuals in the United States are classified as having angina pectoris. Of these individuals with angina pectoris, approximately 150,000 to 250,000 annually are diagnosed as having refractory coronary artery disease and cannot be successfully treated with conventional cardiovascular therapies.
About the GENASIS Trial
GENASIS is a randomized, double-blinded, dose-ranging and placebo- controlled Phase IIb clinical trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The GENASIS trial will be conducted in approximately 25 cardiac medical centers throughout the United States.
In the GENASIS trial, defined doses of VEGF-2 in the form of "naked" plasmid DNA, a non-viral delivery vector, are delivered to diseased heart muscle tissue via the Boston Scientific Corporation Stiletto(TM) endocardial direct injection catheter system. The injection procedure is performed by a cardiologist in a standard cardiac laboratory.
VEGF-2 is a growth factor that is believed to promote the development of supplemental collateral blood vessels, a process known as therapeutic angiogenesis. Once administered, the DNA plasmid appears to be taken up and expressed by myocardium near the injection site. Inside the cell, the DNA plasmid then enters the nucleus of the cell without a requirement of incorporation into the genomic DNA. The Phase IIb clinical trial expects to see the effect of the expression of DNA-encoded VEGF-2, which in turn stimulates the growth of new blood vessels by promoting the migration and proliferation of endothelial cells in the heart.
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. Corautus is currently developing and testing a gene transfer product using the Vascular Endothelial Growth Factor-2 (VEGF-2) gene to promote therapeutic angiogenesis in ischemic muscle for the relief of severe angina. 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 http://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 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 ongoing clinical trial, recommendations from our Data Monitoring Committee, the potential benefits from previous clinical trials, sufficient enrollment of suitable patients in our clinical trial, future results of operations or our financial condition, adequacy of funding, 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' 2004 Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on March 22, 2005, and are incorporated by reference into this press release.
CONTACT: Investor Relations, Jack W. Callicutt of Corautus Genetics Inc., 404-526-6200, jcallicutt@corautus.com ; and Media Relations, Justin Jackson of Burns McClellan, on behalf of Corautus Genetics Inc., 212-213-0006, jjackson@burnsmc.com
Corautus Genetics Inc.
CONTACT: Investor Relations, Jack W. Callicutt of Corautus GeneticsInc., +1-404-526-6200, or jcallicutt@corautus.com ; or Media Relations, JustinJackson of Burns McClellan, +1-212-213-0006, or jjackson@burnsmc.com , forCorautus Genetics Inc.
Web site: http://www.corautus.com/
Source: PRNewswire-FirstCall
Related Articles
- Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis
- Genetic Data From HortResearch and Genesis R&D Promises New Future for Kiwifruit
- Living Cell Technologies Reports Clinical Benefit for All Patients in Diabetes Trial
- MethylGene Presents Clinical Biomarker Data for MGCD0103 and Preclinical Efficacy Data in Combination With Taxanes at AACR Annual Meeting
- Data From Patient Subsets of E-HEALING, a Worldwide Registry, Support Use of OrbusNeich's Genous(TM) Bio-Engineered R Stent(TM) As Alternative to Drug- Eluting Stents
- Ipilimumab (MDX-010) Safety and Clinical Response Data in Lymphomas and Leukemia Presented at the 48th American Society of Hematology Annual Meeting
- Scientists propose sharing genetic data on bird flu
- Encouraging Interim Results From a Phase I/II Trial of Targeted Genetics' tgAAC94 in Patients With Inflammatory Arthritis; Interim Data Show Positive Trends Toward Sustained Improvement in Signs and Symptoms of Disease
- Clinical Data Initiates Patient Enrollment for Vilazodone Phase 3 Clinical Trial; Top-Line Data Anticipated in Mid-2007
 |
 |
User Comments (0)
RSS Feeds