Friday, July 13, 2007
Amsterdam-based CRO Clinquest Group has acquired a stake in Enceladus Pharmaceuticals, the Netherlands-based developer of the inflammatory disorder treatment Nanocort—the product is in phase II trials. Clinquest also gathered a group of additional investment groups to back Enceladus as it brings more products to market.
Genzyme reported negative results from a pivotal trial of hylastan for the treatment of pain associated with osteoarthritis of the knee. This double-blind, active-control study enrolled 400 subjects in North America and Europe. Subjects were randomized to receive two intra-articular injections of hylastan delivered two weeks apart, a single injection of hylastan, or an injection of a corticosteroid. They were then evaluated for 26 weeks. Each of the three treatment arms showed a statistically significant reduction in knee pain from baseline.
The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has accredited its largest group of institutions at one time in its six-year history. In total, 16 organizations gained AAHRPP approval. The certification is valid for three years. The AAHRPP is a non-profit organization that offers accreditation to organizations that conduct or review research with humans.
Maryland-based CRO United BioSource Corporation (UBC), in conjunction with eClinical firm Medidata Solutions, and the adaptive trials tools and modeling company Tessella, have joined together to educate the industry on the use of adaptive clinical trials in drug development. The companies are producing a series of free webinars—six in total—that will feature expertise from industry professionals and regulatory authorities on how to overcome some of the challenges of these studies.
NovaCardia reported positive preliminary results from a phase III trial of KW-3902 for the treatment of acute congestive heart failure (CHF). This double-blind, randomized trial enrolled 304 subjects with CHF and renal impairment. Subjects received placebo or 10, 20 or 30 milligram doses of intravenous KW- 3902, administered daily for up to three days. All subjects received intravenous furosemide.
Dublin-based ICON Clinical has established a new business unit called its lifecycle sciences group, focusing specifically on outcomes research and economic analysis services. The news was announced during the Drug Information Association (DIA) 43rd Annual Meeting in Atlanta. The group will work with stakeholders across the client organization in area such as clinical development, but also with sales and marketing, medical affairs and strategic development groups—units where most contract research organizations (CROs) have less interaction with.