Phase II Trials
04 Dezembro 2007 - 7:50AM
UK Regulatory
RNS Number:1009J
Arana Therapeutics Limited
04 December 2007
For Immediate Release 4 December 2007
ARANA THERAPEUTICS LTD
Arana Announces Phase II Trials For Lead Compound ART621
* First Domain Antibody To Enter Phase II Trials
* Phase IIa Psoriasis Study Planned For 1Q 2008
* Phase II Rheumatoid Arthritis Study 3Q 2008
* Phase I Trial Confirms Competitive ART621 Half Life
Arana Therapeutics Limited (ASX: AAH, AIM: AAHx) the Australian
biopharmaceutical company focused on the development of antibody and peptide
products for the treatment of inflammatory diseases and cancer, 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(R)
and greater than Remicade(R) and Enbrel(R)."
"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," Dr 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," Dr 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.
For further information: www.arana.com
For further information, please contact:
Arana Therapeutics Ltd
Dr John Chiplin, Chief Executive Officer +61 (0)2 9870 8788
Niall Henderson, Chief Financial Officer +61 (0)2 9870 8788
Buchanan Communications
Lisa Baderoon (lisab@buchanan.uk.com) +44 (0)20 7466 5000
Rebecca Skye Dietrich / Catherine Breen
Nomura Code Securities
Charles Walker +44 (0)20 7776 1206
This information is provided by RNS
The company news service from the London Stock Exchange
END
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