Healthcare Industry News: lapatinib ditosylate
News Release - May 24, 2006
GlaxoSmithKline Demonstrates Progress of Oncology Portfolio; New Data to Be Presented at ASCO 2006LONDON and PHILADELPHIA, May 24 (HSMN NewsFeed) -- GlaxoSmithKline (NYSE: GSK ) will present new data across a broad, innovative portfolio of experimental cancer medicines and vaccines at the annual American Society of Clinical Oncology (ASCO) meeting in Atlanta starting Friday, June 2nd.
GSK will make 34 data presentations at ASCO including 13 for the investigational oral drug Tykerb® (lapatinib ditosylate), a small molecule dual kinase inhibitor being developed for the treatment of breast cancer and other solid tumors.
Already this year, GSK has progressed three potential oncology products, eltrombopag, pazopanib and casopitant into Phase III pivotal trials. Data will be presented on each of these compounds at ASCO.
Data to be shown at ASCO include:
-- Late breaking data from Tykerb in trastuzumab-resistant breast cancer will be shown in a special session (Saturday, June 3rd, 9:30-10:15am)
-- Phase II trial of Tykerb for brain metastases in patients with HER2- positive breast cancer (Abstract #503, Saturday, June 3rd, 9:00-9:15am)
-- Results from the phase II trial of Tykerb monotherapy in patients with relapsed/refractory inflammatory breast cancer (IBC): Clinical activity and biologic predictors of response. (Abstract #502, Saturday, June 3rd, 8:45-9:00am)
-- Results of an analysis of cardiac function in 2,812 patients treated with Tykerb. (Abstract #583, Sunday, June 4th, 2:00-6:00pm)
-- Efficacy of Tykerb in patients with high tumor EGFR expression: Results of a phase III trial in advanced renal cell carcinoma (RCC). (Abstract #4502, Saturday, June 3rd, 1:00-1:15pm)
-- Interim results from Phase II study of MAGE-A3 antigen specific cancer immunotherapeutic as adjuvant therapy in stage IB/II MAGE-A3-positive, completely resected, Non-Small Cell Lung Cancer (NSCLC). (Abstract #7019, Sunday, June 4th, 4:15-4:30pm)
-- Results on AS04-containing human papillomavirus (HPV) 16/18 vaccine for prevention of cervical cancer in women 15-55 years old. (Abstract #1008, Monday, June 5th, 12:15-12:30pm)
-- Review of eltrombopag, a novel, oral platelet growth factor, increases platelet counts in thrombocytopenic patients and healthy subjects (Abstract #8602, Poster session, Saturday, June 3rd, 2:00-6:00pm)
-- Results from a multicenter, randomized, double-blind, ondansetron (ond)-controlled, dose-ranging, parallel group trial of the neurokinin- 1 receptor antagonist (NK-1 RA) casopitant mesylate for chemotherapy- induced nausea/vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC). (Abstract #8512, Poster session, Sunday, June 4th, 8:00am-Noon)
-- Data from a randomized phase II trial of the neurokinin-1 receptor antagonist (NK-1 RA) casopitant mesylate with ondansetron (ond)/dexamethasone (dex) for chemotherapy-induced nausea/vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC). (Abstract #8513, Poster session, Sunday, June 4th, 8:00am-Noon)
-- Results from a Phase I, open-label study of the safety and pharmacokinetics (PK) of pazopanib for blocking angiogenesis (the development of new blood vessels that feed tumor growth) and Tykerb administered concurrently. (Abstract #3088, poster session, Sunday, June 4th, 2:00-6:00pm)
Notes to editors:
GlaxoSmithKline (GSK) is one of the world's leading pharmaceutical and healthcare companies and is committed to improving the quality of human life by enabling people to do more, feel better and live longer. Collaboration is a fundamental part of how GSK achieves its commitment to a broad spectrum of cancer care. GSK has partnered with over 160 of the leading cancer centers worldwide and is committed to these partnerships to promote breakthrough work in the field of oncology. For more information visit http://www.gsk.com.
TYKERB® (lapatinib ditosylate) is also designated as GW572016.
TYKERB® (lapatinib ditosylate) is a registered trademark of the GlaxoSmithKline group of companies in the United States.
TYCERB® (lapatinib ditosylate) is a registered trademark of the GlaxoSmithKline group of companies in Europe.
TYKERB® is an investigational drug and is not yet approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory body.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report on Form 20-F for 2006.
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