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OSI Pharmaceuticals Provides Update on OSI-906 Data Being Presented on May 30th at the Upcoming Annual Meeting of the American Society of Clinical Oncology ASCO
2009 JUN 1 - (NewsRx.com) -- OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced preliminary data from two Phase I dose escalation studies of oral OSI-906, a small molecule insulin-like growth factor-1 receptor (IGF-1R) tyrosine kinase inhibitor, in patients with advanced solid tumors. The studies, along with a third on-going Phase I trial assessing OSI-906 in combination with Tarceva, comprise part of the Company’s principal oncology development program targeting the IGF-1R. The program also includes translational research and biomarker development activities around this highly attractive oncology target. In an intermittent oral dosing study, OSI-906 was well-tolerated up to doses of 450mg and has provided preliminary evidence of anti-tumor activity, with one confirmed partial response in an adrenocortical carcinoma (ACC) patient; one minor response in a patient with non-small cell lung cancer (NSCLC); 14 patients with stabilization of their disease for longer than 12 weeks including 7 patients with stabilization of their disease for longer than 24 weeks (out of 27 patients evaluable for tumor response to date). In a continuous dosing study, OSI-906 also had an acceptable safety profile and disease stabilization for longer than 12 weeks has been observed in 8 out of 29 patients evaluable for tumor response to date. Both Phase I studies continue to accrue patients at higher doses to determine the maximum tolerated dose (MTD) for both intermittent and continuous dosing of OSI-906, and to establish a recommended dose and dosing schedule for a Phase II clinical trial of OSI-906. “We believe these data, along with early data from an additional combination Phase I study with Tarceva, continue to position OSI-906 as a potential first-in-class small molecule inhibitor of the IGF-1R,” stated Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “Our extensive research around this crucial oncology signaling target has led us to develop a comprehensive development effort that includes targeting tumors such as ACC and ovarian cancer, where IGF-2 over-expression could indicate a particular dependence on this signaling pathway, and also NSCLC, where our understanding of EMT and compensatory signaling mechanism suggest that a Tarceva/OSI-906 combination could be particularly effective. With continued progress in our program we believe we could begin two registration-oriented trials – a monotherapy study in ACC in 2009 and a Tarceva combination study in NSCLC in 2010.” The OSI-906 Phase I single-agent data will be presented in two poster presentations at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, FL on May 30, 2009 between 8 a.m. and noon EDT (Abstracts #3544 and #2559). Study Results Preliminary activity in adrenocortical tumor (ACC) in phase I dose escalation study of intermittent oral dosing of OSI-906, a small molecule insulin like growth factor -1 receptor (IGF-1R) tyrosine kinase inhibitor in patients with advanced solid tumors- C.P. Carden, et al. (Abstract #3544) The primary objective of this study (OSI-906-102) is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of oral OSI-906 for three intermittent dosing schedules: Schedule 1: days 1-3, every 14 days; Schedule 2: days 1-5, every 14 days; Schedule 3: days 1-7, every 14 days. Secondary objectives include safety profile, pharmacokinetics (PK) and pharmacodynamics (PD) profiles and preliminary anti-tumor activity. Preliminary results from 33 patients evaluable to date showed that OSI-906 was well-tolerated up to doses of 450mg, with no dose limiting toxicities (DLTs) and no grade 3 or 4 toxicities reported to date. Most common adverse events were grade 1 rash, diarrhea, fatigue and peripheral edema. Frequency and severity of toxicities did not correlate with dose level. Two cases of hyperglycemia (one grade 1; one grade 2) were reported. Keywords: Adrenocortical Cancer, Adrenocortical Carcinoma, Anticancer Therapy, Clinical Oncology, Clinical Trial Research, Drugs, Enzyme Research, Erlotinib Hydrochloride, Kinase, Lung Neoplasms, Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma, OSI Pharmaceuticals Inc., Oncology, Pharmaceutical Business, Pharmaceutical Company, Proteins, Proteomics, Small Molecule Inhibitor, Solid Cancers, Solid Carcinomas, Tarceva, Therapy, Treatment, Tyrosine Kinase, OSI Pharmaceuticals Inc. This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2009, Biotech Business Week via NewsRx.com.
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