Oct 24 Omrix Biopharmaceuticals Inc OMRI.O
said it will recommence a U.S. mid-stage trial of its
anti-bleeding product Fibrin Pad that was suspended after a
patient experienced post-operative bleeding.
The company said the trail will continue without any
modification and it will resume patient enrolment.
The mid-stage study of Fibrin Pad was suspended on Oct. 9,
a day after an interim analysis showed the product to be
superior to an already approved haemostat, Surgicel, made by
Omrix's partner Ethicon, a Johnson & Johnson (JNJ.N) unit.
On Friday, Omrix said a data safety monitoring board
concluded its investigation and authorized the company to
recommence the trial, which is testing Fibrin Pad for mild to
On Oct. 8, the company said it had one serious adverse
event of post-operative bleeding in the mid-stage trials in
Israel, where the product was being tested for severe bleeding.
Shares of Omrix closed up 12 percent at $14.75 Friday on
(Reporting by Vidya L Nathan in Bangalore; Editing by Vinu