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news.The FDA has approved UK-based biotech company Astex Therapeutics' application to begin testing its investigational cancer treatment, AT9283, in humans.
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An initial phase I study on AT9283 in hematological cancers will be conducted at a leading oncology center in the US, and the company plans to initiate additional studies in North America and Europe in patients with solid tumors during the second half of the year.
AT9283, an aurora kinase inhibitor, was discovered and developed internally using Astex’s fragment-based drug discovery platform, Pyramid. This is Astex’s second investigational new drug approval in less than 12 months; the company’s lead compound AT7519 is already in phase I trials in the US and in the UK.
“We are delighted both to have been given the go-ahead by the regulatory authorities to advance AT9283 into clinical development, and to be working with some of the world’s leading cancer experts on our clinical program. We are now putting the final preparations in place to begin this first clinical trial of AT9283 in the coming weeks,” said Dr Harren Jhoti, chief scientific officer of Astex.