Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Ipsen's Partner Announces Hold Of Phase III Trials Of IB1001 For Hemophilia B

Ipsen's (IPSEF.PK) partner, Inspiration Biopharmaceuticals Inc., was notified by the Food and Drug Administration or FDA that both studies evaluating the safety and efficacy of IB1001, an investigational intravenous recombinant factor IX (rFIX) therapy for the treatment and prevention of bleeding episodes in people with hemophilia B, were placed on clinical hold.

The clinical hold impacts 2 ongoing IB1001 clinical trials such as a phase III study evaluating the safety and efficacy of IB1001 to treat and prevent bleeding episodes in adults with hemophilia B, and a phase III study evaluating IB1001 to treat and prevent bleeding episodes in previously treated pediatric subjects with hemophilia B.

The adult study has completed its primary analysis period. Following the FDA's request, Inspiration has notified clinical sites in the U.S. to hold treatment of patients with IB1001. Also, Inspiration Biopharmaceuticals is sharing the FDA directive with regulators in countries outside of the U.S. where the studies are being conducted.

Totally, 86 people with hemophilia B have received IB1001 in trials and, to date, no adverse events related to the development of antibodies to CHO protein have been reported. Moreover, no relationship has been showed between the development of antibodies to CHO protein and the development of any antibodies to factor IX, the company added.

Register
To receive FREE breaking news email alerts for Ipsen Promesses and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Beverages giant Coca-Cola Co. reported Tuesday a profit for the third quarter that decreased 14 percent from last year, despite higher worldwide volumes, reflecting a revenue drop. Adjusted earnings per share matched analysts' expectations, even as quarterly revenues missed their estimates. Following the announcement, the company's shares are trading more than five percent lower in early deals. Apple Inc. said Monday that its fourth quarter profit rose 13% from last year, driven by strong sales of its iPhones and Mac computers. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly sales. At the same time, the company gave an upbeat revenue forecast for the current quarter, which includes the all important holiday season. Programmable chipmaker Xilinx Inc. (XLNX) said Thursday after the markets closed that its second quarter profit rose 21% from last year, helped by higher revenue and better cost control. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue....
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.