WILMINGTON, Del., Nov. 16 /PRNewswire-FirstCall/ -- Preliminary results from a Phase II study showing clinical data with the investigational drug ZACTIMA(TM) (ZD6474) in patients with a rare form of thyroid cancer(1) were presented at the AACR-NCI-EORTC Annual Meeting in Philadelphia today. The study is an ongoing, single-arm investigation of ZACTIMA in patients with hereditary medullary thyroid cancer.
The first 11 patients in this study received once daily treatment with ZACTIMA 300mg for at least three months, and were assessed for tumor response. Of the 11 patients, initial results show two experienced a partial response, where their measurable tumor shrank by 30% or more, and nine patients experienced stable disease.(1) Side effects seen with ZACTIMA in this study included rash, nausea, diarrhea, hypertension and asymptomatic QT prolongation.
The data collected also measured levels of calcitonin and carcinoembryonic antigen, which are considered to be markers in patients with medullary thyroid cancer. Calcitonin and carcinoembryonic antigen levels were reduced by an average of 72% and 25% respectively, following treatment with ZACTIMA.(1)
Lead trial investigator Professor Samuel Wells, MD, Duke University Medical Center, Durham, NC, commented, “These preliminary data with ZACTIMA are encouraging for patients with hereditary medullary thyroid cancer.”
ZACTIMA is being studied as a multitargeted compound, directed to the inhibition of key cell signaling pathways involved in tumor growth and spread. Tumor cells are targeted through inhibition of epidermal growth factor receptor (EGFR) and RET tyrosine kinases, while tumor blood supply is targeted through inhibition of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase. RET tyrosine kinase activity is an important growth driver in certain thyroid tumors.
These data follow the recent announcement that the US Food and Drug Administration (FDA) granted ZACTIMA orphan-drug designation for the treatment of patients with follicular, medullary, anaplastic, and locally advanced and metastatic papillary thyroid cancer.
It is estimated that 2-3% of the estimated 25,000 new cases of thyroid cancer diagnosed in the US in 2005 are medullary thyroid cancer and of these, around a quarter are hereditary.(2)
AstraZeneca is currently enrolling patients in a ZACTIMA study in locally advanced or metastatic hereditary medullary thyroid cancer at Duke University in Durham, NC. For more information on this trial, please call 919-668-3533.
In addition to evaluating ZACTIMA in thyroid cancer, AstraZeneca will begin recruitment into Phase III studies evaluating ZACTIMA in advanced non- small-cell lung cancer in the next few months.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com.
This press release contains forward-looking statements with respect to AstraZeneca’s business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company’s Annual Report/Form 20-F for 2004.
REFERENCES
1. Wells S et al. The Use of ZACTIMA(TM) (ZD6474) in the Treatment of Patients with Hereditary Medullary Thyroid Carcinoma. Presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, November 2005.
2. National Cancer Institute. Genetics of Medullary Thyroid Cancer. http://www.cancer.gov/cancertopics/pdq/genetics/medullarythyroid/healthprofess ional. Last accessed 05 October 2005.
AstraZeneca
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