Sep 29 2008
Biotechnology company Arana Therapeutics Limited today announced it has submitted an Investigational New Drug application (IND) to the FDA (U.S. Food and Drug Administration) for the anti-inflammatory product ART621 in a rheumatoid arthritis (RA) indication.
The IND includes a Phase II dose ranging study of ART621/221 in RA which is planned to be an international multi-centred trial of approximately 200 patients.
The study is designed to establish the appropriate dosing for ART621 in RA and will compare three doses of ART621 with a placebo in patients also taking methotrexate. Arana expects to commence recruitment for the study in late quarter 4 2008, subject to FDA feedback.
Taking into account their global expertise and experience, the management of the study has been awarded to Quintiles Transnational, the world's largest contract research organisation.
Commenting on these developments, CEO John Chiplin said: "We are very excited that ART621 has reached this important milestone - being Arana's first IND. We are now a confirmed clinical stage company and with our strong pipeline look forward to filing more IND's in the future."
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