AstraZeneca's Iressa (ZD1839) anti-tumour activity

ASTRAZENECA'S IRESSA (ZD1839) DEMONSTRATES ENCOURAGING ANTI-TUMOUR ACTIVITY IN NON-SMALL CELL LUNG CANCER 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. The data were presented at the American Society of Clinical Oncology (ASCO) 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 Institute for Cancer Studies, University of Birmingham, 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). 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 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 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:AZN) 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 including pain management, cardiovascular, central nervous system (CNS) and respiratory products. 24 May 2000 Further enquiries to: Staffan Ternby, +46 8 553 261 07 Steve Brown, +44 20 7304 5033 Lucy Williams, +44 20 7304 5034 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