CAMBRIDGE, England, April 25 /PRNewswire/ -- Astex Therapeutics, the fragment-based drug discovery and development company, today 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 Aurora Kinase inhibitor, AT9283, for the treatment of cancer. AT9283 was discovered and developed internally using Astex's fragment-based drug discovery platform, Pyramid(TM).
This is Astex's second IND 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. An initial Phase I study on AT9283 in haematological cancers will be conducted at one of the world's leading oncology centres in the United States, and the company plans to initiate additional studies in N. America and Europe in patients with solid tumours during the second half of the year.
"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 programme. 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 and Acting Chief Executive of Astex. "This second IND underscores the productivity of our fragment-based discovery engine. In addition to AT9283, we have a number of other unpartnered programs also progressing towards the clinic and we are well on the way to meeting our corporate goal of generating at least one IND per year from our proprietary platform."
Contacts Astex Therapeutics Dr Harren Jhoti Chief Scientific Officer and Acting Chief Executive Tel +44 (0) 1223 226200 Email: h.jhoti@astex-therapeutics.com Web: http://www.astex-therapeutics.com Brunswick Group LLP Jon Coles / Wendell Verbeek / Justine McIlroy / Alex Tweed Tel. +44 (0) 207 404 5959 Email: astex@brunswickgroup.com Editor's notes: AT9283: Aurora kinase inhibitor
AT9283 is an inhibitor of mitosis (cell division) and is the second most progressed drug candidate in the Astex portfolio of novel molecularly targeted cancer drugs. All of Astex's current products have been discovered internally using its proprietary drug discovery approach. AT9283 is a potent inhibitor of the Aurora A and B kinases and has been shown to arrest tumour growth in a range of tumour models. Aurora kinases play a key role in mitotic checkpoint control in cell division. Both Aurora A and B are over-expressed in many human tumours and are believed to be excellent targets for anti-cancer therapy.
About Astex Therapeutics
Astex Therapeutics is a UK-based biotechnology company producing novel small molecule therapeutics. Using its pioneering fragment-based drug discovery approach, Astex has rapidly established a broad pipeline of next- generation, molecularly-targeted oncology drugs the first of which, AT7519, is currently in Phase I clinical trials in the US and in the UK. Astex has two further product candidates including AT9311, an oral cell cycle inhibitor, and AT9283, an aurora kinase inhibitor. AT9311 is in formal pre-clinical development with IND/CTAs planned for the second half of 2006.
Astex's leading position in fragment-based drug discovery derives from its integrated discovery engine, Pyramid(TM). High-throughput X-ray crystallography and other biophysical techniques are used to identify drug fragments bound to target proteins and to transform the fragments, using efficient medicinal chemistry, into potent, selective drug candidates. Pyramid(TM) has been successfully applied across a wide variety of therapeutic targets, including those regarded as 'intractable' by the pharmaceutical industry, resulting in lead compounds for the potential treatment of cancer, inflammation and Alzheimer's disease.
Astex's unprecedented productivity in lead discovery has been endorsed by drug discovery and development alliances with major pharmaceutical companies including AstraZeneca, Astellas Pharma, Boehringer Ingelheim, Mitsubishi Pharma, Novartis, sanofi-aventis and Schering AG. These alliances have a total value in excess of US $1 billion including the US $520m alliance signed with Novartis in December 2005 which is focused on the development of AT9311 and AT7519.
Astex Therapeutics was established in 1999 and is well financed by leading, blue chip US and European investors (Abingworth, Advent International, Alta Partners, Apax, GIMV, HypoVereinsbank, Oxford Bioscience Partners, Schering AG and the University of Cambridge).
For further information on Astex Therapeutics please visit the Company's website at http://www.astex-therapeutics.com
Astex TherapeuticsCONTACT: Dr Harren Jhoti, Chief Scientific Officer and Acting ChiefExecutive of Astex Therapeutics, +44-1223-226200,h.jhoti@astex-therapeutics.com; or Jon Coles, or Wendell Verbeek, orJustine McIlroy, or Alex Tweed, all of Brunswick Group LLP,+44-207-404-5959, astex@brunswickgroup.com
Web site: http://www.astex-therapeutics.com/
