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Clinical Trials

Date: 2011-07-28

Type of information: Initiation of preclinical development

phase: 3

Announcement: results

Company: Ipsen (France) Inspiration Biopharmaceuticals (USA)

Product: OBI-1 (intravenous recombinant porcine factor VIII product - rpFVIII)

Action mechanism:

Disease: treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia

Therapeutic area: Hematological diseases - Genetic diseases

Country:

Trial details:

Latest news:

* On November 28, 2011, Ipsen has announced that its partner Inspiration Biopharmaceuticals has initiated the treatment of the first patient in the second of two pivotal studies from the OBI-1’s Accur8 clinical trial program. In this newly initiated clinical study, OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product, will be evaluated for the treatment of individuals with congenital hemophilia A, who have developed inhibitory antibodies (inhibitors) against their human FVIII replacement therapy. Under the partnership agreement signed with Inspiration in January 2010, the initiation of this clinical study triggers the subscription by Ipsen to a US$25 million convertible note newly issued by Inspiration. Ipsen’s fully diluted share ownership position in Inspiration now reaches about 40.7%. The first pivotal study of OBI-1 for the treatment of severe bleedings in individuals with acquired hemophilia A, caused by the development of inhibitors against human FVIII has been initiated by Inspiration Pharmaceuticals in November 2010.
* On July 28, 2011, Ipsen has announced that its partner Inspiration Biopharmaceuticals presented data from its clinical development program for OBI-1, an intravenous recombinant porcine factor VIII product (rpFVIII), intended for the treatment of bleeding in people with hemophilia A with inhibitors and in people with acquired hemophilia. The data were presented in a Scientific Session held in conjunction with the 23rd Congress of the International Society on Thrombosis and Haemostasis (ISTH), which was chaired by Amy Shapiro, M.D., Co-Medical Director at the Indiana Hemophilia and Thrombosis Center (IHTC). During the Scientific Session, Anne Greist, M.D., Co-Medical Director at IHTC, presented interim results from the first registration study in the OBI-1 Accur8 clinical trial program. A total of three patients with acquired hemophilia, who had experienced severe bleeds not controlled with by-passing agents, were treated with OBI-1; in all three patients, treatment with OBI-1 stopped the bleeding. Further data on hemostatic efficacy and safety are being collected as part of the Accur8 program, designed to study OBI-1 in acquired hemophilia. According to Inspiration, a second study in individuals with congenital hemophilia A who have developed inhibitors against FVIII is set to commence later this year (Accur8 Allo-antibody clinical trial).

Is general: Yes