The study is Arana’s inaugural trial following the merger of Peptech and EvoGenix in August 2007. The study will provide repeat dose, pharmacokinetic, safety and preliminary anti-TNF efficacy data for ART621 in a psoriasis population. The results will also be used to inform the design of longer duration clinical studies in rheumatoid arthritis and other indications.
In November 2007 Arana successfully completed a Phase I clinical trial of ART621 which showed the drug was well tolerated in healthy volunteers. Earlier pre-clinical trials recorded potency levels at least equivalent to a market-leading anti-TNF drug in an animal model of rheumatoid arthritis. ART621 was also shown to have design features that make it suitable for commercial production.
Dr John Chiplin, CEO of Arana said “The commencement of this trial heralds the start of a very exciting period for Arana as we expand our clinical activities. This initial study in psoriasis will quickly enable us to obtain the data necessary to allow our Phase II rheumatoid arthritis program to commence. We expect to file an IND for ART621 in rheumatoid arthritis with the US Food and Drug Administration by the end of September 2008. Assuming no delays, we plan to commence our Phase II rheumatoid arthritis study towards the end of calendar year 2008, once we have FDA approval for the protocol and positive interim data from our psoriasis trial.”
“Both psoriasis and rheumatoid arthritis are key markets for the currently registered anti-TNF’s. The novel nature of the product should allow ART621, if successful, to gain a significant share of a very large market,” Dr Chiplin said.
There are currently three major anti-TNF drugs on the market, Remicade®, Humira® and Enbrel®. In 2007 these drugs had combined global sales of US$12.8 billion. With a projected market size of greater than US$20 billion in 2012 this is a rapidly growing market, which is far from saturated.
It is well documented that patients can develop a resistance to one antibody treatment, but respond to another. The list of indications that can be treated with anti-TNF drugs is increasing and there is also a trend developing in diagnosing and treating the inflammatory conditions at a much earlier stage.
Clinical Trial Details
The study known as ART621-201 is designed to evaluate the safety, efficacy and pharmacokinetics of 3 dose levels of ART621 using a randomised, double-blind, placebo-controlled design in subjects with plaque psoriasis. The primary objective is to evaluate the safety and tolerability of subcutaneous injections of ART621 given every 2 weeks for 6 doses as assessed by adverse events and clinical laboratory data. Assessments of efficacy will include the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), photographs and the Dermatology Life Quality Index (DLQI).
Each subject will be on-study for 18-20 weeks, consisting of a 2-4 week screening period, followed by a 12 week treatment period and then a 4 week follow up. Each subject will receive their designated dose of ART621 on 6 occasions over the 12 week treatment period and will be monitored closely throughout.
The study will be conducted to ICH GCP standard at two Australian study centres – Nucleus Network in Melbourne and CMAX in Adelaide – both of which have experience in psoriasis trials and biological therapies. The study expects to recruit between 40-60 subjects over a 4-6 month period. The first patient is expected to be dosed during the next several weeks with the formal results of the study anticipated approximately 4 months after recruitment closes.
More details are included in the attached Appendix.
About Arana Therapeutics:
Arana Therapeutics (ASX: AAH; AIM: AAHx) is an international biopharmaceutical company formed through the merger of Peptech and EvoGenix in August 2007. The company uses superior technology to develop next generation drugs that will improve the lives of patients with inflammatory diseases and cancer.
Arana Therapeutics’ innovative engineering technologies provide the basis for clinical development in the antibody space, a market which draws on high demand. Arana Therapeutics has the financial stability and management expertise to accelerate its clinical programs, and is on track to have at least 3 clinical stage assets within three years.
Arana is listed on the Australian Securities Exchange (ASX) and the London Stock Exchange (AIM).
The pipeline consists of four lead drug programs: ART621 to treat severe rheumatoid arthritis, psoriasis and other inflammatory diseases; ART010 to treat osteoporosis and bone cancer; ART104 to treat solid tumours in colorectal cancer; and ART150 for lung cancer and melanoma. Additionally, the company has earlier stage products in development for the treatment of a range of conditions including age related macular degeneration, psoriasis, colorectal cancer, and leukemia.
Arana has recurring revenues from commercial and development partnerships with six international companies including GSK, CSL, Centocor (J&J) and Abbott Laboratories.
For further information: www.arana.com
Contact Information:
Company: Dr John Chiplin Chief Executive Officer Arana Therapeutics Limited T: + 61 2 8061 9900 E: jchiplin@arana.com Investor & Media Relations: Paul Dekkers Buchan Consulting T: + 61 2 9237 2800 Mobile: 0418 218 722 E: pdekkers@
