AstraZeneca's Iressa - ZD1839 - Demonstrates Encouraging Anti-Tumour Activity in Non-Small Cell Lung Cancer.Business Editors & Health/Medical Writers STOCKHOLM, Sweden--(BUSINESS WIRE)--May 24, 2000 AstraZeneca today announced that final results from Phase I clinical trials of its novel anti-cancer compound known as Iressa or ZD1839, show, in a small number of patients, encouraging anti-tumour activity or disease stabilisation, particularly in non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. . The data were presented at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) annual meeting in New Orleans. "From these preliminary trials, our results show that Iressa demonstrates encouraging anti-tumour activity, particularly in non-small cell lung cancer. Ongoing trials will help us determine the best dose and how Iressa can be combined with other cancer treatments including chemotherapy," said Dr David Ferry, Medical Oncologist, CRC (Cyclical Redundancy Checking) An error checking technique used to ensure the accuracy of transmitting digital data. The transmitted messages are divided into predetermined lengths which, used as dividends, are divided by a fixed divisor. Institute for Cancer Studies, University of Birmingham Due to Birmingham's role as a centre of light engineering, the university traditionally had a special focus on science, engineering and commerce, as well as coal mining. It now teaches a full range of academic subjects and has five-star rating for teaching and research in several , UK. "AstraZeneca is encouraged by Iressa's progress in early research. As a company, we have been committed to cancer research for over 20 years and it is exciting to see these new approaches to treating cancer come to fruition. It is critical that we all support participation in clinical trials in order for Iressa and other promising medications to be fully developed," stated Dr. George Blackledge, Medical Director of Oncology at AstraZeneca. The authors reported final results from a Phase I dose escalation trial intended to evaluate the tolerability and activity of ZD1839 in patients with solid malignant tumours known to express or over-express epidermal growth factor receptors (EGFR EGFR Epidermal Growth Factor Receptor (a kinase enzyme) EGFR Estimated Glomerular Filtration Rate ). Escalating doses of ZD1839 (50-mg to 700- mg once daily) were given orally for 14 days followed by 14 days' observation. In the absence of progression or dose-limiting toxicity, ZD1839 was re-initiated at the same dose. A total of 64 patients (25 male, 39 female; median age 54) were enrolled in the trial, and had received at least one prior chemotherapy regimen. The authors concluded that ZD1839 was well tolerated, demonstrated predictable pharmacokinetics compatible with once-daily oral administration, and showed encouraging anti-tumour activity, particularly in non-small cell lung cancer. Overall fifteen patients with a range of tumour types had stable disease or response for @4 months. Anti-tumour activity was most evident among the 16 non-small cell lung cancer patients. The most common adverse events were mild to moderate diarrhoea and acne-like skin rash. Serious adverse events were rare and usually related to disease progression. Dose-limiting toxicity was observed at the 700-mg dose level. The chemical pathway that ZD1839 is designed to target is triggered by an epidermal growth factor Epidermal growth factor or EGF is a growth factor that plays an important role in the regulation of cell growth, proliferation and differentiation. Human EGF is a 6045 Da protein with 53 amino acid residues and three intramolecular disulfide bonds. which binds to a receptor on the cell surface called the epidermal growth factor receptors or EGFR. The EGFR sends signals within the cell via a signal-transmitter enzyme called tyrosine kinase (TK), which instructs the cell to grow and divide. ZD1839 blocks this TK enzyme, effectively switching off the signals from the EGFR. This potentially stops the cancer from growing. Simply called an EGFR-TK EGFR-TK Epidermal Growth Factor Receptor Tyrosine Kinase inhibitor, ZD1839 is administered as a once-daily oral tablet. Research on ZD1839 is continuing and depending on the results, AstraZeneca hopes to file new drug applications world-wide within the next few years. ZD1839 is currently not on the market in any country. AstraZeneca now intends to significantly widen the research programme for ZD1839 to allow wider access to future clinical trials to establish the safety and efficacy of the agent. Phase III studies in advanced non-small cell lung cancer will begin over the next few months. AstraZeneca (NYSE NYSE See: New York Stock Exchange :AZN AZN Asian ) is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of $15 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia anaesthesia anesthesia. including pain management, cardiovascular, central nervous system (CNS See Continuous net settlement. CNS See continuous net settlement (CNS). ) and respiratory products. Editors Note Please visit the World Wide Web for the information on Epidermal growth factor receptors (EGFR) and their potential role in the treatment of cancer at www.EGFR-INFO.com. ---------------- Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/05/24/20000524BIT00180/bit0001.doc http://www.bit.se/bitonline/2000/05/24/20000524BIT00180/bit0002.pdf |
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