KYOTO, Japan, July 28, 2011 /PRNewswire/ — Inspiration
Biopharmaceuticals, Inc. (Inspiration) today announced data
from its clinical development program for OBI-1, an intravenous
(IV) 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
clinical trial program, designed to study OBI-1 in acquired
hemophilia. A second study in individuals with congenital
hemophilia A who have developed inhibitors against FVIII is set to
commence later this year.
Additional reports from the Scientific Session confirmed
findings from the Phase 2 study in congenital hemophilia A with
inhibitors; that OBI-1 effectively resulted in hemostasis, and
controlled all non-life/non-limb threatening bleeding episodes in
individuals with congenital hemophilia A and inhibitors, even in
the presence of high inhibitor levels. All 25 bleeds in the study
were controlled, and twenty out of 25 bleeds (80%) were controlled
with two infusions. In over 40 infusions administered, OBI-1 was
well tolerated by all participants and no drug-related serious
adverse events were observed.
Dr. Gre
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