October 24, 2008 / 9:10 PM / in 9 years

UPDATE 1-Omrix to resume U.S. trials of anti-bleeding product

Oct 24 (Reuters) - 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 moderate bleeding.

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 Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Vinu Pilakkott)

    0 : 0
    • narrow-browser-and-phone
    • medium-browser-and-portrait-tablet
    • landscape-tablet
    • medium-wide-browser
    • wide-browser-and-larger
    • medium-browser-and-landscape-tablet
    • medium-wide-browser-and-larger
    • above-phone
    • portrait-tablet-and-above
    • above-portrait-tablet
    • landscape-tablet-and-above
    • landscape-tablet-and-medium-wide-browser
    • portrait-tablet-and-below
    • landscape-tablet-and-below