A Medical Device Daily

The European Union, through the Sixth Framework Program, has approved a project led by IDIBAPS-Hospital Clinic , with the aim to validate the IBDchip (Inflammatory Bowel Disease DNA Chip) within the European Community

It is said to be the world’s first diagnostic DNA chip, and has the main object to predict prognosis and response to therapy of patients suffering from inflammatory bowel disease. The program has a EUR 2.5 million budget for the next three years for conducting several studies, including a total of 3,000 to 4,000 patients in seven European countries.

A consortium that includes seven European centers in inflammatory diseases and genetics; an enterprise with the technology for manufacturing the chip; and an enterprise in laser technology, in charge of optimizing the reading of the chips, has been created for conducting this project.

The consortium is coordinated by Dr. Miquel Sans, researcher of the IDIBAPS Physiopathology of Gastrointestinal Lesions Group and member of the gastroenterology facility of Hospital Clinic de Barcelona.

The IBDchip is a DNA chip especially developed by the Basque company Progenika Biopharma in collaboration with Sans. The chip is a simple device requiring only a small blood sample. The DNA is obtained from this sample, which is placed in a glass support (the IBDchip) for the detection of 61 mutations, using laser technology.

Crohn’s disease and colitis ulcerosa are highly heterogenic pathologies with unpredictable clinical course and drug response. The prevalence of these diseases has significantly increased in developed countries during the last decades. In Spain, more than 100,000 people are affected, and the incidence of the disease is 15 to 20 new cases per 100,000 inhabitants per year. The number of patients in Europe rose to 1.5 million.

About 15% of patients have at least one relative suffering from one of these pathologies, which involve an important loss of quality of life. The treatment costs are of EUR 7,382 a year per patient, meaning a total cost of EUR 1 billion a year for the public healthcare system.

The analysis of the first Spanish IBDchip Study aiming to predict the clinical course of Spanish intestinal bowel disease patients is being conducted. This work, also led by Sans, includes more than 900 patients.

Definitive analysis of the first and second phases of the study is expected within the next two months. The final results will determine the exact usefulness of the IBDchip in Spanish patients.

The new European project also aims to study the European usefulness of the tool. “This step is indispensable due to the fact that there is a large genetic variability among the several geographic areas and ethnic groups of our continent, and the mathematical prediction models resulting from the European study will probably be different from those obtained in Spain,” IDIBAPS said.

One of the first aims of the European IBDchip Project is to identify new genetic factors with potential interest regarding intestinal bowel disease. The IBDchip’s version that will be used in such studies is likely to include more than 200 genetic factors instead of the 61 of the first-phase IBDchip.

Datascope, Sorin in global distribution accord

The Sorin Group (Milan, Italy) reported that it has signed an exclusive five-year worldwide agreement, excluding the U.S. and Japan, with Datascope (Montvale, New Jersey), for that company to distribute Sorin’s peripheral vascular stent products. The deal includes a call option for Datascope to acquire Sorin’s peripheral stent business within two years.

Sorin’s peripheral stent products are used in the treatment of peripheral arterial disease (PAD) and use the company’s Carbofilm technology, which the company says has clinically proven biocompatible and hemocompatible characteristics.

The product line includes balloon-expandable and self-expanding stent systems principally for use in the treatment of the iliac arteries, renal arteries and infrapopliteal lesions, as well as balloon systems for use in percutaneous transluminal angioplasty.

The Sorin products will be distributed by Datascope’s InterVascular subsidiary, described by the Italian company as “a worldwide leader in manufacturing and distributing vascular grafts to cardiac and vascular surgeons.”

Datascope said it believes that the peripheral stent products are an “attractive addition” to the Intervascular division’s product portfolio and will benefit from Intervascular’s marketing, sales, clinical education/training and new product development capabilities.

“We are confident that this agreement represents a unique opportunity to strengthen and reinforce Sorin’s technological leadership and awareness in the interventional cardiology market, benefiting from Datascope’s sales and distribution network,” said Franco Vallana, president of Sorin’s Cardiac Surgery business unit and chief scientific officer of Sorin Group.

Nino Laudani, president of InterVascular, said, “We believe that Sorin’s peripheral vascular stents will be an attractive addition to [our] portfolio. We look forward to leveraging our capabilities in marketing, sales, clinical education and training, as well as product development, to accelerate the adoption of these products.”

He added that his firm’s strength at the cardiovascular surgery “call point,” as well as its commitment to technology innovation, “should enable us to increase peripheral stent sales and expand the overall adoption rate of stents by vascular surgeons and interventionalists.”

InterVascular is a global supplier of a full line of polyester, collagen-coated knitted and woven vascular grafts and patches.

The companies said the worldwide market for peripheral vascular stents and PTA balloons, excluding the U.S. and Japan, is estimated at $192 million annually.

ALS group allies with European firms

The ALS Association (Calabasas Hills, California) said it has partnered with two European biotech companies developing new stem cell and gene manipulation technologies to search for treatment for amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease).

It said that the $3 million funding from the ALS Association’s Translational Research Advancing Therapy for ALS (TREAT) program is the largest from that program to date focused on new drug candidates. Several pilot clinical trials of existing candidates are already under way with TREAT ALS funding.

Partnering with the ALS Association are Galapagos (Mechelen, Belgium) and Stem Cell Innovations (SCI; Leiden, the Netherlands/Houston). Funding is contingent on the companies’ success at specific points in the project.

“The unique ability provided by SCI to screen human motor neurons at large scale, and Galapagos’ target discovery engine, will open new approaches to developing medicines that may stop ALS,” said Lucie Bruijn, science director and vice president of the ALS Association. “We see this alliance as an important initiative within The ALS Association’s mission to find a cure for and improve living with ALS.”

Stem Cell Innovations has a human stem cell technology based on cells that are exempt from the presidential ban in the U.S. These pluripotent stem cells are able to produce motor neurons that can grow robustly in the lab.

“The human motor neuron cultures derived from our PluriCells will form the basis of this exciting alliance,” said SCI’s CEO, James Kelly.

Galapagos has a technology that brings in or removes, in turn, large numbers of genes to lab-grown cells that reflect aspects of a disease of interest. This identifies which genes might serve as drug targets in the disease. The Galapagos technology will be applied to the SCI motor neuron cells.