Astex Therapeutics, a UK-based biotechnology company producing novel small molecule therapeutics, announced that it had begun dosing first patients in a phase I/IIa clinical trial of its investigational anti-cancer drug AT9283. Astex discovered AT9283, a potent inhibitor of Aurora kinases, using its innovative fragment-based drug discovery technology, Pyramid.
This is Astex's second product to enter clinical development. The company's lead product, AT7519, is already in a phase I trial at sites in the US and the UK. This initial clinical trial of AT9283 is designed to assess safety and tolerability and may provide preliminary evidence of efficacy in patients with haematological malignancies. It is being conducted at the University of Texas MD Anderson Cancer Center, one of the world's leading oncology centres. Astex plans to initiate additional clinical studies of AT9283 in North America and Europe within the next six months.
In addition to its inhibition of Aurora kinases, AT9283 is highly active against the Gleevec resistant T315I abl mutation and could benefit patients who have failed treatment with agents such as Gleevec and Sprycel. AT9283 is also a potent inhibitor of JAK-2 and the present trial will assess its activity in patients with myeloproliferative disorders associated with activating mutations of this protein.
"We are delighted to have initiated this trial in collaboration with Dr Hagop Kantarjian, a leading expert in the field of leukaemia", said Leon Bushara, chief executive officer of Astex. "Astex has moved two products into clinical development within twelve months, underscoring the unique productivity of our R&D effort. Our objective is to advance at least one new product into clinical trials every year."
"Targeted agents like the Aurora kinase inhibitor AT9283 have already shown evidence of clinical efficacy in the treatment of patients with haematological malignancies, such as Chronic Myelogenous Leukaemia (CML). I am very pleased to be involved in trialling this novel agent which could be of significant benefit to cancer patients," said Dr Hagop Kantarjian, Professor of Medicine and Chairman of the Department of Leukemia at University of Texas MD Anderson Cancer Center.