Arana Therapeutics Limited today announced that it has completed recruitment in its Phase II dose-ranging psoriasis study for its anti-inflammatory drug ART621
Sydney, Australia | August 28, 2008 | Biotechnology company Arana Therapeutics Limited (ASX: AAH) today announced that it has completed recruitment in its Phase II dose-ranging psoriasis study for its anti-inflammatory drug ART621. Completion of recruitment means that formal results of the study should be available in early 2009.
* Patient recruitment in psoriasis trial for Arana’s inflammatory drug ART621 completed; results expected in Q1 2009
* IND to be submitted in Q4 2008
* Rheumatoid arthritis trial planned to commence by end Q4 2008
Arana also confirmed that it is planning to submit an Investigational New Drug (IND) application for ART621 in the rheumatoid arthritis indication in the fourth quarter of 2008.
Commenting on these developments, CEO John Chiplin said: "We are pleased with the clinical progress of ART621 and are excited to be finalising the IND documentation, the submission of which is a crucial milestone towards the commercialisation of ART621."
“Subject to feedback from the FDA (U.S. Food and Drug Administration), we look forward to the commencement of our rheumatoid arthritis program by the end of this year which we have been carefully planning for some time now.” Dr Chiplin said.
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.
“We are targeting two of the key anti-TNF markets – rheumatoid arthritis and psoriasis. If successful in trials, the unique nature of our product should enable us to gain a valuable share of the large and growing anti-TNF market” Dr Chiplin said.
The total market for existing anti-TNF’s, Remicade®, Humira® and Enbrel®, was US$12.8 billion in 2007. This market is expected to exceed US$20 billion by 2012.
About Arana Therapeutics:
Arana Therapeutics (ASX: AAH) 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.
The pipeline consists of four lead drug programs: ART621 to treat severe rheumatoid arthritis 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 leukaemia.
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
SOURCE: Arana Therapeutics Limited
Post Views: 139
Arana Therapeutics Limited today announced that it has completed recruitment in its Phase II dose-ranging psoriasis study for its anti-inflammatory drug ART621
Sydney, Australia | August 28, 2008 | Biotechnology company Arana Therapeutics Limited (ASX: AAH) today announced that it has completed recruitment in its Phase II dose-ranging psoriasis study for its anti-inflammatory drug ART621. Completion of recruitment means that formal results of the study should be available in early 2009.
* Patient recruitment in psoriasis trial for Arana’s inflammatory drug ART621 completed; results expected in Q1 2009
* IND to be submitted in Q4 2008
* Rheumatoid arthritis trial planned to commence by end Q4 2008
Arana also confirmed that it is planning to submit an Investigational New Drug (IND) application for ART621 in the rheumatoid arthritis indication in the fourth quarter of 2008.
Commenting on these developments, CEO John Chiplin said: "We are pleased with the clinical progress of ART621 and are excited to be finalising the IND documentation, the submission of which is a crucial milestone towards the commercialisation of ART621."
“Subject to feedback from the FDA (U.S. Food and Drug Administration), we look forward to the commencement of our rheumatoid arthritis program by the end of this year which we have been carefully planning for some time now.” Dr Chiplin said.
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.
“We are targeting two of the key anti-TNF markets – rheumatoid arthritis and psoriasis. If successful in trials, the unique nature of our product should enable us to gain a valuable share of the large and growing anti-TNF market” Dr Chiplin said.
The total market for existing anti-TNF’s, Remicade®, Humira® and Enbrel®, was US$12.8 billion in 2007. This market is expected to exceed US$20 billion by 2012.
About Arana Therapeutics:
Arana Therapeutics (ASX: AAH) 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.
The pipeline consists of four lead drug programs: ART621 to treat severe rheumatoid arthritis 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 leukaemia.
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
SOURCE: Arana Therapeutics Limited
Post Views: 139
