Published on November 2, 2008 at 6:10 PM
Biotechnology company Arana Therapeutics Limited today announced that lead anti-inflammatory compound, ART621 has successfully passed review of its rheumatoid arthritis Investigational New Drug (IND) application by the US Food and Drug Administration (FDA).
IND status indicates regulatory approval to conduct clinical trials in humans in the United States and represents the first review of ART621 data by a major Regulatory Authority.
Arana can now proceed with its planned Phase II study in rheumatoid arthritis.
Dr John Chiplin Arana's CEO said "We are delighted with this positive result which validates Arana's technology and development expertise. Crucially, an open IND increases our commercial visibility and is an important catalyst for our ongoing partnering discussions."
"Arana is at the forefront of new antibody technologies and we are one of the few companies to have second generation antibody products in clinical trials."
"We look forward to commencing our Phase II rheumatoid arthritis programme by the end of this year," he added.
http://www.arana.com