Cambridge, UK, 4th November 2010. Astex Therapeutics, the UK-based biotechnology company developing targeted therapies for oncology and virology, and the NCIC Clinical Trials Group in Canada, announced today the initiation of a Phase II clinical trial of Astex’s combinatorial oncogenic kinase inhibitor, AT9283, to treat patients with relapsed or refractory multiple myeloma, an incurable blood cancer1.
The trial will be conducted at multiple centres across Canada and is sponsored by the NCIC Clinical Trials Group (NCIC CTG). The new study is designed to test single agent activity of AT9283 and builds on work recently published demonstrating both single agent and combination activity of AT9283 in multiple myeloma cell lines2.
Two Phase I trials of AT9283 in patients with solid tumours have been completed; the first, sponsored by Astex, in patients with advanced solid malignancies, was carried out jointly at the Northern Institute for Cancer Research, Newcastle, UK and at the Royal Marsden Hospital, in London, while the second clinical study treating patients with advanced or metastatic solid tumors or Non-Hodgkin’s Lymphoma on an alternative dosing schedule, was conducted and sponsored by the Investigational New Drug Program of the NCIC CTG and completed in 2010. A Phase I clinical study to assess the safety and tolerability of AT9283 in patients with leukaemias has also been completed at the University of Texas, MD Anderson Cancer Center and at the University of Alabama at Birmingham, Comprehensive Cancer Center, and a further Phase I clinical study of AT9283 in children and adolescents with relapsed or refractory solid tumors is ongoing in the UK, sponsored by Cancer Research UK.
Harren Jhoti, CEO of Astex said, “This new trial of AT9283 builds on the long standing and successful partnership we have had with the NCIC Clinical Trials Group since 2005. AT9283 is an exciting and differentiated new inhibitor of pathways central to the proliferation of many cancer cells, and we are delighted to be working with the NCIC Clinical Trials Group to evaluate its potential in the treatment of multiple myeloma.”
Commenting on the commencement of the Phase II study, Lesley Seymour, Professor of Oncology and Co-Director of the IND Program at NCIC CTG said, “Having been involved in the Phase I clinical development of AT9283, we are excited about being involved in the continued clinical evaluation of the compound, using the dose and schedule identified in our Phase I study. AT9283 offers the potential of a new therapy for patients with multiple myeloma who have relapsed following treatment with other agents.”
1http://www.clinicaltrials.gov Identifier NCT01145989.
2Blood (ASH) Annual Meeting Abstracts 2009 114: Abstract 3833M
Jeremy Carmichael, PhD
Director of Business Development
Astex Therapeutics Ltd
436 Cambridge Science Park
Milton Road, Cambridge
CB4 0QA, UK
Astex is a UK-based biotechnology company that discovers and develops novel small molecule therapeutics. Using its pioneering fragment-based drug discovery platform Pyramid™, Astex has built a pipeline of five molecularly-targeted oncology drugs, of which three are currently being tested in clinical trials and two are in pre-clinical development.
In addition to its proprietary research programmes, Astex’s productivity in lead discovery has been endorsed through numerous partnerships with major pharmaceutical companies, including AstraZeneca, Bayer-Schering, Boehringer Ingelheim, GlaxoSmithKline, Novartis and Johnson & Johnson.
For further information on Astex please visit the Company’s website at www.astex-therapeutics.com
About the NCIC Clinical Trials Group
The NCIC Clinical Trials Group is a cooperative oncology group which carries out clinical trials in cancer therapy, supportive care and prevention across Canada and internationally. It is one of the national programmes and networks of the Canadian Cancer Society Research Institute (CCSRI), and is supported by the Canadian Cancer Society (CCS).
For further information on the NCIC Clinical Trials Group please visit the group’s website at www.ctg.queensu.ca
AT9283 is a small molecule inhibitor of Aurora kinases A and B, with potent activity also against c-ABL and JAK2. Aurora kinases have been demonstrated to be over-expressed in several high risk cancers. Inhibitors of Aurora kinases, such as AT9283, represent attractive novel anti-cancer agents for the treatment of a broad range of solid tumours and haematological malignancies as evidenced by anticancer activity in tumour models and emerging early clinical data in adults. AT9283 has completed two Phase I studies in patients with solid tumours using alternative dosing regimens and has been found to be well tolerated in a Phase I/IIa study in adult patients with haematological malignancies with early signals of efficacy in approximately one third of adult patients with relapsed/refractory acute myeloid leukemia. A further Phase I study in paediatric and adolescent patients with solid tumours is ongoing in collaboration with Cancer Research UK.