AMedical Device Daily

Corautus Genetics (Atlanta) and Boehringer Ingelheim Austria (Vienna) reported that they have entered into a long-term manufacturing agreement to produce vascular endothelial growth factor 2 (VEGF-2) plasmid DNA for a Phase III trial and future commercial use for the treatment of severe angina and other indications.

Richard Otto, Corautus CEO, said, “We are pleased to enter this agreement . . . as we look beyond our ongoing Phase IIb GENASIS trial and begin planning the Phase III trial and projected future commercialization of our therapeutic for severe angina.”

He added: “Since it is a multi-year commitment for each company, Boehringer Ingelheim Austria began the feasibility and GMP implementation activities several months ago in order to meet the projected timelines for a Phase III registration trial of the VEGF-2 therapeutic.”

Otto said Boehringer Ingelheim Austria’s facility in Vienna is scalable and will accommodate the quantities necessary to expand his company’s therapeutic portfolio of clinical initiatives for the treatment of cardiac and peripheral vascular disease. He added that the facility is FDA-certified for commercial manufacturing of biopharmaceutical therapeutics.

Corautus’ regenerative cardiac therapy seeks to treat the underlying causes of severe coronary artery disease through direct injection of VEGF-2 into ischemic cardiac muscle. Based on data from earlier Phase I and Phase IIa clinical trials, the company said it believes that when VEGF-2 is introduced into ischemic cardiac muscle, it will stimulate the growth of new blood vessels and improve cardiac function.

The VEGF-2 is delivered via a non-viral vector system in which the naked DNA plasmid is injected directly into the tissue, where the gene transfer occurs. Corautus said it believes that there are several advantages to this over other gene transfer delivery systems, including minimal side effects and the fact that the gene is not inserted into the genome.

GENASIS is a randomized, double-blinded, dose-ranging and placebo-controlled Phase IIb trial, which will enroll 404 patients with Class III or IV angina that are not suitable candidates for traditional revascularization procedures. The trial will be conducted in about 30 cardiac medical centers throughout the U.S.

Defined doses of VEGF-2 are delivered to diseased heart muscle tissue via the Boston Scientific (Natick, Massachusetts) Stiletto endocardial direct injection catheter system. The injection procedure is performed by a cardiologist in a standard cardiac cath lab.

Corautus entered into a strategic alliance with Boston Scientific in July 2003 to develop, commercialize and distribute the VEGF-2 gene therapy products.

Deal combines ELN sector firms

IDBS (Guildsford, UK) said it has acquired the assets of privately held Deffinity Solutions (Portsmouth, UK). Deffinity is a provider of compliant workflow software, including DAT-LAB, an extendable next-generation electronic laboratory notebook (ELN) that can be adapted to meet the needs of multiple scientific disciplines.

IDBS is a provider of integrated data management, analysis and decision-making software for the life sciences industry. It said the Deffinity acquisition would enable it to provide secure and compliant protection of its customers’ intellectual property while continuing to facilitate collaborative research between biologists and chemists.

Neil Kipling, IDBS chairman and CEO, said, “real success will only be achieved through the seamless integration of the ELN with solid data management, analysis and decision-making capability that can accommodate the working methods and dialects specific to each scientific discipline within the drug discovery workflow. I believe this is where ELN must mature and become a part of a complete enterprise data management solution for drug creation.”

Agreement on m-doc development

Alltracel Pharmaceuticals (Dubin, Ireland), a healthcare technology company focused on the consumer wound care, oral care and coronary health markets, said it has signed a technology and product development agreement with nanofiber technology specialists Elmarco (Prague, Czech Republic) for the development of a next-generation delivery platform for Alltracel’s m-doc wound care technology.

Elmarco is a specialist R&D and manufacturing company specializing in advanced manufacturing for the semi-conductor components industry, as well as equipment for industrial production of nanofibrous non-woven materials.

Working with the textiles faculty of the Technical University of Liberic, Elmarco has developed a proprietary process for spinning polymers into nano-scale fibers for a range of industrial, chemical, micro-electronic and biomedical applications.

m-doc (micro-dispersed oxidized cellulose)-based nanofiber wound care prototypes have been developed over the past few months and are now at an advanced stage of technical evaluation.

Alltracel CEO Tony Richardson said, “Alltracel has always been committed to innovation in our markets and we are particularly excited by the prospects for m-doc-based nanofibrous advanced wound care delivery systems.”