Arana -- Sydney: 22 September 2008 - Biotechnology company Arana Therapeutics Limited (ASX: AAH) today provided an update on the major inflammatory compounds in its drug development pipeline. As part of this update, Arana said it has developed a new antibody candidate ART123, targeting inflammatory diseases and it plans to start a Phase I clinical trial for age-related macular degeneration (AMD) candidate PMX53 in 2009.
ART123 was produced using Arana’s proprietary antibody engineering technologies. Patents have been filed around the novel mechanism of action of ART123, which has demonstrated efficacy in a pre-clinical psoriasis model. Preclinical safety studies are expected to commence in 2010.
Arana has developed and tested several new formulations of PMX53 in animal models of AMD, psoriasis and osteoarthritis. The AMD clinical trial is expected to start in the first half of 2009, subject to the successful completion of ongoing pre-clinical dose-ranging studies. Data from long term pre-clinical osteoarthritis studies are also expected to be available in early 2009. Arana has no current plans for further development of the psoriasis indication.
Arana also said that lead compound ART621 continues to progress in its development with several major milestones expected in the next six months. These include an Investigational New Drug application (IND) for the rheumatoid arthritis indication in the fourth quarter of 2008, a Phase II study in rheumatoid arthritis planned to commence also in the fourth quarter of 2008, and safety and efficacy data from a psoriasis study expected in the first quarter of 2009.
Commenting on these developments, CEO John Chiplin said: “We are delighted with the progress in our inflammatory pipeline, with products targeting important and large disease markets where antibody products have revolutionised treatments.”
“The addition of ART123 strengthens our portfolio and demonstrates the depth of our engineering technologies and intellectual property capabilities. We look forward to updating the market on our future progress especially in relation to ART621 which has several important milestones ahead including an IND submission in the next month or so,” Dr Chiplin added.
Ends 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.
ART123 is a new antibody targeting the interleukin 12/23 pathway. The IL12/23 pathway is implicated in the pathogenesis of psoriasis and other inflammatory disorders and has been clinically validated.
PMX53 is a C5a complement inhibitor. Complement is a naturally occurring protein that is implicated in many human inflammatory diseases. Arana has now developed and tested new formulations of PMX53 in animal models of age-related macular degeneration, psoriasis and osteoarthritis.
For further information: www.arana.com
Contact information:
Company:
Dr John Chiplin
Chief Executive Officer
Arana Therapeutics
T: + 61 2 8061 9900
E: jchiplin@arana.com
Investor & Media Relations:
Ellie Papathanasiou
Buchan Consulting
T: 61 9237 2800
M: 61 405 342 490
E: epapathanasiou@bcg.com.au
