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Animal Studies Show Promising Therapeutic Dosing Results Using an Antisense Agent to Treat Heart Disease

Posted on: Wednesday, 25 July 2007, 09:19 CDT

Animal studies of a potentially breakthrough medical technology that uses a novel antisense agent to arrest the process of coronary arteries becoming reblocked after treatment with angioplasty and stenting have shown highly promising results, a spokesman for Global Therapeutics, a Cook Medical company, announced today.

Global Therapeutics reports that preclinical studies have shown successful delivery of the agent to the specific site of stenting. Delivery of a therapeutic dose of the antisense agent was achieved safely without any adverse systemic effects. Furthermore, it was shown that the target RNA, from the c-myc gene, one of the main causes of restenosis, was effectively inhibited by the antisense compound AVI-5126 developed by Cook Medical's partner AVI BioPharma, Inc. (Nasdaq: AVII).

"Our main goal, following the achieved silencing of the target RNA, was to develop a system that is user-friendly and would not add time to the overall procedure for the physician," said Joseph B. Horn, president of Global Therapeutics. "The animal studies just completed have shown conclusively that the c-myc inhibitor (AVI-5126) we have been exploring produces a therapeutic effect at the dosages used. With the success of this phase of our preclinical investigation, our plans are to initiate a human clinical trial in the near future, pending regulatory consent."

Global Therapeutics plans to pursue this technology beyond the preclinical setting and into a clinical trial in Europe later this year. The study design will incorporate up to 20 investigational centers throughout Europe with the intent to support a CE-mark filing.

"We view this kit as a unique system needed by the industry given all the negative press surrounding the current generation of pharmaceutical-eluting coronary stents. It was developed in conjunction with Cook Medical's product development team and includes a bare metal cobalt chromium stent, a sub-selective drug delivery catheter and the AVI-5126 antisense drug component," Horn said. "This technology will allow cardiologists to treat lesions with a drug designed to prevent restenosis without the use of any non-therapeutic additives such as a polymer."

Sebastian Phillip, M.D., head of the Cardiovascular Research Center at the Westgerman Heart Center in Essen and a key investigator in the APPRAISAL Trial, remarked. "Antisense therapy to prevent in-stent stenosis is an exciting breakthrough in the treatment of coronary artery disease. Sub-selective delivery of AVI-5126 will open a new approach combining the safety of a bare metal stent with reducing restenosis comparable to DES. We are excited to begin this trial at the end of the year."

Global Therapeutics licenses the AVI-5126 c-myc antisense agent from AVI BioPharma, which has ongoing manufacturing responsibilities. The technology is an investigational device not available in the United States or other markets at this time.

About Cook Medical

Cook Medical was the first company to introduce interventional devices in the United States. Today, the company integrates device design, biopharma, gene and cell therapy and biotech to enhance patient safety and improve clinical outcomes in the fields of aortic intervention; cardiology; critical care medicine; gastroenterology; radiology, peripheral vascular, bone access and oncology; surgery and soft tissue repair; urology; and assisted reproductive technology, gynecology and high-risk obstetrics. Cook won the prestigious Medical Device Manufacturer of the Year Award for 2006 from Medical Device & Diagnostic Industry magazine. For more information, visit www.cookmedical.com.

About AVI BioPharma

AVI BioPharma develops therapeutic products for the treatment of life-threatening diseases using third-generation NeuGene(R) antisense drugs and ESPRIT exon skipping technology. AVI's lead NeuGene antisense compound is designed to target cell proliferation disorders, including cardiovascular restenosis. In addition to targeting specific genes in the body, AVI's antiviral program uses NeuGene antisense compounds to combat disease by targeting single-stranded RNA viruses, including West Nile virus, hepatitis C virus, dengue virus, Ebola virus, and H5N1 avian influenza virus. AVI's NeuGene-based ESPRIT technology is initially being applied to potential treatments for Duchenne muscular dystrophy. More information about AVI is available on the company's Web site at http://www.avibio.com.

Source: Business Wire

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