LAGUNA NIGUEL, Calif., July 14 /PRNewswire/ -- Inspiration Biopharmaceuticals today announced the presentation of positive preclinical safety, toxicology and preliminary pharmacokinetic data on its lead product, IB1001, a novel recombinant Factor IX product to treat patients with hemophilia B. The data were highlighted in an oral presentation yesterday at the XXII Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Boston, Mass. IB1001 has completed preclinical testing and is currently being evaluated in a Phase 1/2-3 clinical study.
In the study, the safety, toxicology and pharmacokinetics of IB1001 were evaluated in animal models and compared to commercially available Factor IX products. Results showed that IB1001 has an excellent safety profile in animal models and a similar pharmacokinetic profile when compared to currently available Factor IX products.
"These results and the progress that we have made in advancing our protein manufacturing technology have facilitated the advancement of IB1001 into a Phase 1/2-3 clinical program," said Michael Griffith, Ph.D., President and CEO, Inspiration Biopharmaceuticals. "Our ultimate goal is to increase accessibility to prophylactic treatment and improve the quality of life for people suffering from hemophilia around the world. We expect to move IB1001 into a pivotal trial and look forward to updating you on all developments related to this program."
IB1001 is an intravenous recombinant Factor IX product for the acute and preventative treatment of the bleeding disorder associated with hemophilia B. IB1001 is produced with Inspiration's proprietary recombinant protein manufacturing technology, which significantly increases cell-line productivity.
Hemophilia is a lifelong, inherited bleeding disorder cause
|SOURCE Inspiration Biopharmaceuticals|
Copyright©2009 PR Newswire.
All rights reserved