Astex announces IND approval for novel cancer drug AT7519
Astex announced that the United States food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for the clinical development of its proprietary cell cycle inhibitor, AT7519, for the treatment of cancer. AT7519 was discovered and developed internally using Astex's fragment-based drug discovery platform, Pyramid(TM), and progressed from first synthesis to regulatory approval in just 14 months. The Company is in the process of initiating a multi-centre Phase I trial of AT7519 in patients with refractory solid tumours in the US and in the UK.
The IND approval closely follows that of Astex's Clinical Trial Authorisation (CTA) application for AT7519 by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The Phase I study will be conducted at the Arizona Cancer Center under the direction of Dr Daniel Von Hoff and Dr Daruka Mahadevan and at the Northern Institute for Cancer Research at the University of Newcastle upon Tyne under the direction of Professor Hilary Calvert, who is the International Co-ordinating Principle Investigator.
"We are very pleased to have been given the go-ahead by the regulatory authorities both in the US and in the UK to advance AT7519 into clinical development and to be working with some of the world's leading cancer experts on our Phase I study. We are now putting the final preparations in place to begin the clinical trial of AT7519 in the coming weeks," said Dr Harren Jhoti, Chief Scientific Officer of Astex.
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