Friday, July 29, 2011
Micell Technologies has completed patient enrollment in its DESSOLVE II CE Mark clinical study of the MiStentR drug-eluting coronary stent system. The MiStent DES is an ultra-thin drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating formulation. Enrollment of 183 patients across 26 study centers throughout Europe and New Zealand was accomplished ahead of schedule.
Lutonix has enrolled its first patient in the LEVANT 2 clinical trial, a global, multi-center, randomized trial evaluating the safety and efficacy of the Moxy(TM) Drug Coated Balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD). The first case was performed at St. John’s Hospital in Springfield, Ill., by Dr. Jeff Goldstein.
The FDA approved the launching in the U.S. of a clinical trial for gene therapy for a rare immunodeficiency, Wiskott-Aldrich syndrome (WAS). After its implementation in Paris and London, this trial based on preclinical research performed at Genethon (Evry, France) which also manufactures the GMP gene therapy product, is now going to be launched in Boston. It’s one of the first international clinical trials using a gene therapy treatment for a rare disease.
Tibotec Virco-Virology BVBA, part of Janssen Pharmaceutical, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of INCIVO (telaprevir), a direct acting antiviral (DAA) for the treatment of chronic genotype-1 hepatitis C virus (HCV), in combination with pegylated-interferon and ribavirin, the previously accepted standard of care.
Janssen Biotech, formerly Centocor Ortho Biotech, reported the Gastrointestinal Drugs Advisory Committee (GIDAC) of the FDA recommended the approval of REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.