31st Oct 2005 13:30
AstraZeneca PLC31 October 2005 FDA GRANTS ZD6474 (ZACTIMA(TM)) ORPHAN DRUG DESIGNATION FOR THE INVESTIGATION OF RARE FORMS OF THYROID CANCER AstraZeneca announced today that the US Food and Drug Administration (FDA) hasgranted ZD6474 (ZACTIMA(TM)) Orphan Drug designation for the treatment ofpatients with follicular, medullary, anaplastic, and locally advanced andmetastatic papillary thyroid cancer. ZD6474 is a unique once-daily oral therapythat selectively targets key cell signalling pathways involved in tumour growthand spread including VEGF (Vascular endothelial growth factor) receptorsignalling and EGF (Epidermal growth factor) receptor signalling. ZD6474 alsoinhibits RET kinase, which drives the growth and survival of certain tumours,and is believed to be an important pathway in medullary thyroid cancer. ZD6474 is currently being developed in a Phase II clinical trial in medullarythyroid cancer and Phase III clinical trials in advanced non-small cell lungcancer are scheduled to start in the next few months. Advanced hereditary medullary thyroid cancer, a rare malignancy, has a poorprognosis and there are currently very limited therapeutic options available.Medullary thyroid cancer is a specific form of thyroid cancer that comprises 2-3per cent of the 25,000 new cases of the disease in the US each year. Neitherstandard chemotherapeutic regimens, nor radiation therapy, provide substantialbenefits in patients with advanced hereditary medullary thyroid carcinoma. Orphan-drug designation was designed to promote the development of products thatdemonstrate promise for the diagnosis and/or treatment of rare diseases orconditions, specifically, those that affect less than 200,000 people in the US. ZD6474 is the first oncology orphan-drug designation AstraZeneca has received.AstraZeneca has also applied for Orphan Drug designation for ZD6474 in medullarythyroid cancer in Europe. For more information about AstraZeneca, please visit: www.astrazeneca.com 31st October 2005 Media Enquiries:Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Enquiries:Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel + 1 212 579 0506 -Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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