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The trial group included 106 previously untreated patients with metastatic NSCLC that was EGFR mutation-positive.
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Gefitinib, an EGFR tyrosine kinase inhibitor, was conditionally approved in the US in 2003 based also on response rates from two Phase II trials.
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As expected in a group of lung cancer patients in Asia, this group predominantly had adenocarcinoma tumors, and 52% were never-smokers, but many had received 2-3 prior treatments, and the majority of the patients had a performance status of 2-3 (definitely marginal to frail).
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The dearth of substantial impact so far suggests the fight against cancer will continue to be a tedious slog, and victories will be scored in weeks or months of extra life, not years.
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Interestingly, both these genetic alterations of the EGFR are correlated with high probability to respond to anti-EGFR agents.
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The matters discussed below constitute the more significant developments since publication of the disclosures concerning legal proceedings in the Company's Annual Report and Form 20-F Information 2014, the Company's Half-Yearly Financial Report for the six-month period to 30 June 2015, and the Third Quarter and Nine-Month Results 2015 (the Disclosures).
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The tests use proprietary algorithms developed by Chronix researchers to detect, analyze and identify cancer-related fragments of circulating DNA that are released into the bloodstream by apoptotic cells.
Analysis of DNA fragmentation by flow cytometry: The hypodiploid (sub-G1) fraction was measured using FACS analysis of propidium-iodide-stained cells after overnight fixation with cold 70 % ethanol.
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Gefitinib concentrations were about 11 times higher than plasma concentrations at 8 hours after dosing.
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The FDA is not currently considering withdrawal of Iressa.
ISEL was conducted in an unselected patient population before it was known that the EGFR mutation was the target for IRESSA and showed a benefit in only some of the patients.
While the exact cause(s) of leukemia is not known, risk factors have been identified, including radiation exposure an".
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