logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Life expectancy at birth in the U.S. is already lower than most other developed nations and is now projected to fall further behind by 2030, according to a new study. It also suggests that by 2030, national female life expectancy in South Korea could break the 90 year barrier. Department store chain J.C. Penney Co. Inc. on Friday reported a turnaround to profit in the fourth quarter as a slight decline in sales was more than offset by lower expenses. Adjusted earnings per share for the quarter beat analysts' expectations, while revenues slightly missed their estimates. Earlier today, J.C. Penny announced a plan to optimize its national retail operations. Google is planning to significantly expand a carpool service on its navigational app Waze, according to a report in the Wall Street Journal. The move indicates the company is edging closer to a potential clash with ride-hailing service Uber Technologies Inc.
comments powered by Disqus
Follow RTT