Astex Receives IND Approval for its Small Molecule HSP90 Inhibitor
AT13387 - Astex Announces Extension of Drug Discovery Alliance
Cambridge, UK, 6th February 2008. Astex Therapeutics announced today that it
has received approval of its Investigational New Drug (IND) application from
the U.S. Food and Drug Administration (FDA) for AT13387, a selective small
molecule inhibitor of Heat Shock Protein 90 (Hsp90) to treat cancer. This is
the third IND candidate from Astex’s internal discovery and development
programmes to be approved. The Company’s other clinical stage products,
AT9283, a multi-targeted kinase inhibitor, and AT7519, a cyclin dependent
kinase inhibitor, received IND approvals in 2006 and 2005 respectively.
Astex plans to begin clinical trials of AT13387 in cancer patients during
2008. Preclinical data showing efficacy for AT13387 in tumour models was
presented at the American Association for Cancer Research annual meeting in
April 2007.
Also today, Astex announced that Novartis has exercised an option to extend
the companies’ drug discovery alliance for the discovery and development of
novel cell cycle control drugs for the treatment of cancer and other human
diseases. Under the terms of the agreement Novartis will fund additional
research at Astex. Astex and Novartis originally entered into a Research
Collaboration and Licensing Agreement in December 2005. This collaboration
could potentially be worth up to $520m if all fees, equity payments, option
payments and milestones are met.
“I am delighted that we have received our third IND approval in as many
years”, said Harren Jhoti, Chief Executive Officer of Astex. “This approval
is a great achievement and a testament to the productivity of our
fragment-based drug discovery platform and keeps us on target to deliver at
least one IND candidate per year.”
“We are also pleased that Novartis has chosen to dedicate further resources
to what has been a very exciting programme of collaborative research. I hope
and expect that this collaborative program will generate novel drug
candidates that specifically target the cell cycle in tumours.”
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Contacts
Astex Therapeutics Limited
Jeremy Carmichael
Director of Business Development
Email: j.carmichael@astex-therapeutics.com
Tel: +44 (0) 1223 226200
Web: www.astex-therapeutics.com
About AT13387
AT13387 is a potent and selective non-natural product inhibitor of Hsp90
derived from the Company’s PyramidTM platform. In tumour cells Hsp90 acts as
a "molecular chaperone" stabilising and preventing the breakdown of key
cancer forming (oncogenic) proteins. These so-called client proteins and
their association with different tumour types include HER2 (the target for
Herceptin® in breast cancer), the androgen receptor (the target for hormone
therapy in prostate cancer), mutant B-raf (melanoma), c-kit (the target for
Gleevec® in gastro-intestinal tumours) and mutant EGFr (the target for
Tarceva® and Iressa® in the treatment of non-small cell lung cancers). The
functional role of Hsp90 means that AT13387 has the potential to control the
proliferation of multiple solid tumours and haematological malignancies
where uncontrolled cell growth is dependent on interaction between Hsp90 and
its client proteins. These include tumour types which have become resistant
to initial therapy.
About Astex
Astex Therapeutics is a 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 two are currently
being tested in clinical trials, one has IND approval, and two are in
pre-clinical development.
In addition to its proprietary research programmes, Astex’s unprecedented
productivity in lead discovery has been endorsed through numerous
partnerships with major pharmaceutical companies, including Novartis,
AstraZeneca, and Boehringer Ingelheim.
For further information on Astex Therapeutics please visit the Company’s
website at
www.astex-therapeutics.com
