Arana Files IND For Lead Anti-Inflammatory Product ART621 In Rheumatoid Arthritis (RA) Indication

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics
Article Date: 01 Oct 2008 - 9:00 PDT

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Biotechnology company Arana Therapeutics Limited (ASX: AAH) 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."

About Arana Therapeutics

Arana Therapeutics (ASX: AAH) is an international biopharmaceutical company focussed on developing next generation antibody based drugs that will improve the lives of patients with inflammatory diseases and cancer.

Arana Therapeutics' innovative engineering technologies provide the basis for developing its next generation antibody candidates. Arana Therapeutics has the financial strength and management expertise to develop its product pipeline.

Arana has a significant track record of commercialising its technologies and has partnerships with GSK, CSL, Centocor (J&J) and Abbott Laboratories.

Additional information

ART621 is an "anti-TNF" - a class of drugs used for the treatment of inflammatory diseases such as rheumatoid arthritis, psoriasis and Crohn's disease. ART621 works by blocking the action of TNF (tumour necrosis factor) a protein which is involved in the generation of inflammation

Arana Therapeutics