A Medical Device Daily

Biosensors (Singapore) reported the enrollment of the first patient into its real-world registry for BioMatrix, the company's drug-eluting stent (DES) system that received CE-mark approval in January.

The registry aims to collect long-term, five-year data on the safety and efficacy of BioMatrix in up to 5,000 patients.

The first patient, a 78-year-old woman suffering from incapacitating grade III angina, was treated with three BioMatrix stents by principal investigator Philip Urban, MD, chief of interventional cardiology, together with his colleague, Edoardo De Benedetti, MD, at Hôpital de la Tour (Geneva, Switzerland).

The company said the design of the e-BioMatrix online registry involves two parallel studies using the same protocol — a post-marketing surveillance study with 100% monitoring of 1,000 patients across more than 10 study sites and a post-marketing registry with 10% monitoring of 4,000 patients across 40 global sites.

"We are very pleased to be initiating such an important registry, unique in its scientific rigor and incorporating a high percentage of monitoring," said Urban. "I believe that this type of study is the right approach to confirm product performance in real-world clinical conditions, and I hope that the large number of targeted patients will confirm the safety profile of this exciting new technology."

The primary endpoint for both studies is MACE (major adverse cardiac events) at 12 months. MACE is a composite measure of cardiac death, myocardial infarction (Q-wave and non-Q-wave) or justified target lesion revascularization. The registry also will examine a range of secondary endpoints, including acute, sub-acute and late stent thrombosis over several periods; MACE at periods up to five years; and death and MI rates for up to five years.

The broad range of inclusion criteria ensure that this will be a "real-world" registry, the company said. Patients must be at least 18 years old, need treatment with a DES and have one or more coronary artery stenoses in a native coronary artery or a saphenous bypass graft from 2.5 mm to 4.0 mm in diameter that can be covered with one or multiple stents. There are no limitations on the number of treated lesions, vessels, or lesion length.

"We are confident that the results from this comprehensive registry will confirm the long-term safety and efficacy of BioMatrix in real-world patients," said Jeffrey Jump, managing director of Biosensors Europe (Morges, Switzerland).

Amgen, Lab21 in predictive partnership

Amgen Limited UK and Lab21 (both Cambridge, UK) have unveiled a partnership to introduce a new genetic therapy test for advanced bowel cancer treatment in the UK.

Lab21 will provide a screening test to indicate which patients are likely to benefit from Amgen's new drug for advanced bowel cancer, Vectibix (panitumumab). It is the first time that the European Commission has licensed a bowel cancer product with the stipulation that a predictive test be carried out.

The Lab 21 test was developed by DxS Ltd., a developer of biomarker assays and companion diagnostics for targeted cancer therapies.

Introduced to the UK earlier this year, Vectibix is licensed for patients with metastatic bowel cancer for whom standard chemotherapy has failed in those with a specific gene mutation.

In a biomarker analysis of the pivotal clinical trial, the drug doubled median progression-free survival in patients with non-mutated (wild type) KRAS (Kirsten Rat Sarcoma 2 viral oncogene homologue) compared with patients receiving best supportive care alone.

Amgen scientists had discovered that only those patients with the non-mutated (wild type) KRAS would respond to Vectibix. Patients with metastatic bowel cancer will be tested for the presence of the wild type KRAS gene before they are prescribed the drug.

About 60% of patients with advanced bowel cancer have wild type KRAS. Of these, up to 60% would be expected to respond to Vectibix. More than 36,000 people in Britain develop bowel cancer every year and about 21,000 have metastatic cancer at any one time.

Dr. Berwyn Clarke, chief scientific officer at Lab21, said, "We are committed to providing a fully comprehensive service for cancer patients and believe that the KRAS test is an important component. Being able to select which patients are more likely to respond to therapy is an important step forward in the treatment of cancer."

Dr. Charles Brigden, medical director of Amgen Limited UK, said, "We are proud that for the first time we will be able to treat advanced bowel cancer patients with a targeted agent based on a predictive biomarker. This is a big step forward toward individualized care in bowel cancer."

"This predictive test is an important advance," said Ian Beaumont, director of public affairs at the charity Bowel Cancer UK. "Launching a new drug for advanced bowel cancer with a predictive screening test brings us closer to personalized care."

New hire for Multisorb Technologies

Multisorb Technologies (Warrington, UK) said it has added a new member to its European sales team. Laurent Rozier has been appointed to the position of business development representative, healthcare packaging for central and southern Europe to work with European customers in addressing their product stability challenges with the use of Multisorb's suite of advanced sorbent technologies.

The company's global healthcare packaging group is focused on providing customers with a full range of technical, regulatory and service support. Rozier, who will be based in Paris, will help Multisorb's European customers meet stability requirements of their healthcare products.

He will be responsible for the continued development of the company's healthcare business, including pharmaceutical, in vitro diagnostic, medical device and dietary supplement market segments in Europe.

Prior to joining Multisorb, Rozier served as a technical sales representative with S&D Chemical, Canada for two years. He has nearly 10 years' experience with healthcare product manufacturers and packagers in Europe.