First Domain Antibody To Enter Phase II Trials
SYDNEY, Australia | December 4, 2007 | Biotechnology company Arana Therapeutics Limited (ASX: AAH, AIM: AAHx) today announced plans for the next stages of clinical development for ART621 – its lead anti-TNF domain-based antibody.
Following successful completion of a Phase I study of ART621, Arana now plans to conduct a 3-month Phase IIa dose-finding study in psoriasis patients ahead of a Phase II study in rheumatoid arthritis.
The psoriasis study, to be conducted in Australia, is expected to commence in Q1/2008 and the Phase II rheumatoid arthritis program is planned to start in Q3/2008.
Arana has also completed pharmacokinetic analysis of data from the Phase I trial of ART621. The data indicate that ART621 has a half life of approximately 14 days in volunteers following subcutaneous administration. These data suggest that, although ART621 is approximately half the size of conventional antibodies, it remains in the blood stream for at least as long as currently marketed anti-TNF antibody products.
A summary of the data from the Phase I study will be presented at the IBC Antibody Therapeutics Conference in San Diego on 5th December.
CEO John Chiplin commented “We are delighted that we have been able to successfully engineer the novel domain construct into a product that has properties in line with the leading marketed products. The indicative half life of ART621 appears to be competitive with the current marketed product Humira® and greater than Remicade® and Enbrel®.”
“We look forward to learning from our clinical trials if the smaller molecular weight of ART621 translates into important clinical benefits in the treatment of inflammatory diseases.”
“The inflammatory disease market continues to grow and the interest in and potential importance of ART621 is reflected by the invitation to present our data at the prestigious IBC Antibody conference,” Chiplin added.
Commenting on the clinical development plans Dr Chiplin said “The favourable half life of ART621 has opened up opportunities in improved dosing for patient benefit. The psoriasis trial will allow us to quickly obtain safety, efficacy and repeat dose pharmacokinetic data to better inform the design of our Phase II rheumatoid arthritis program. “
“Such an approach has been used successfully by other companies and should help speed the development of our TNF product. Furthermore, psoriasis is a valuable market in its own right and contributes to the major markets enjoyed by the currently marketed products,” Chiplin added.
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. With a market capitalisation of around A$250 million and solid cash resources, 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 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.
SOURCE: ARANA THERAPUETICS LIMITED
Post Views: 125
First Domain Antibody To Enter Phase II Trials
SYDNEY, Australia | December 4, 2007 | Biotechnology company Arana Therapeutics Limited (ASX: AAH, AIM: AAHx) today announced plans for the next stages of clinical development for ART621 – its lead anti-TNF domain-based antibody.
Following successful completion of a Phase I study of ART621, Arana now plans to conduct a 3-month Phase IIa dose-finding study in psoriasis patients ahead of a Phase II study in rheumatoid arthritis.
The psoriasis study, to be conducted in Australia, is expected to commence in Q1/2008 and the Phase II rheumatoid arthritis program is planned to start in Q3/2008.
Arana has also completed pharmacokinetic analysis of data from the Phase I trial of ART621. The data indicate that ART621 has a half life of approximately 14 days in volunteers following subcutaneous administration. These data suggest that, although ART621 is approximately half the size of conventional antibodies, it remains in the blood stream for at least as long as currently marketed anti-TNF antibody products.
A summary of the data from the Phase I study will be presented at the IBC Antibody Therapeutics Conference in San Diego on 5th December.
CEO John Chiplin commented “We are delighted that we have been able to successfully engineer the novel domain construct into a product that has properties in line with the leading marketed products. The indicative half life of ART621 appears to be competitive with the current marketed product Humira® and greater than Remicade® and Enbrel®.”
“We look forward to learning from our clinical trials if the smaller molecular weight of ART621 translates into important clinical benefits in the treatment of inflammatory diseases.”
“The inflammatory disease market continues to grow and the interest in and potential importance of ART621 is reflected by the invitation to present our data at the prestigious IBC Antibody conference,” Chiplin added.
Commenting on the clinical development plans Dr Chiplin said “The favourable half life of ART621 has opened up opportunities in improved dosing for patient benefit. The psoriasis trial will allow us to quickly obtain safety, efficacy and repeat dose pharmacokinetic data to better inform the design of our Phase II rheumatoid arthritis program. “
“Such an approach has been used successfully by other companies and should help speed the development of our TNF product. Furthermore, psoriasis is a valuable market in its own right and contributes to the major markets enjoyed by the currently marketed products,” Chiplin added.
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. With a market capitalisation of around A$250 million and solid cash resources, 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 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.
SOURCE: ARANA THERAPUETICS LIMITED
Post Views: 125
