SOUTH SAN FRANCISCO, Calif., May 30 /PRNewswire-FirstCall/ -- Exelixis, Inc. today announced the initiation of a Phase II clinical trial of XL647 in patients with non-small cell lung cancer (NSCLC) who previously benefited from erlotinib or gefitinib or have a documented T790M mutation in the epidermal growth factor receptor (EGFR). Although the T790M mutation confers resistance to the inhibitory effects of erlotinib and gefitinib, preclinical data indicate that XL647 can potently inhibit this mutation and other mutant forms of EGFR. XL647 is designed to simultaneously inhibit the activity of multiple receptor tyrosine kinases, including EGFR, HER2, and vascular endothelial growth factor receptor type 2 (VEGFR2).
“The initiation of this study reflects our ability to match the inhibitory profile of compounds in our pipeline with the tumor biology of specific patient populations,” said Gisela M. Schwab, M.D., senior vice president and chief medical officer at Exelixis. “NSCLC patients who present with the T790M mutation or have relapsed after previous benefit from therapy with erlotinib or gefitinib have few treatment options. Our preclinical data suggest that these patients may benefit from treatment with XL647. We believe confirmation of these data in this Phase II trial would advance the care of these patients while also providing Exelixis with a clear path to late stage development.”
A Phase II trial evaluating XL647 as a first-line therapy is ongoing in patients with stage IIIB or IV NSCLC with adenocarcinoma histology and either a demonstrated activating mutation in EGFR or at least one of the following criteria: Asian, female, or no/minimal smoking history. Data from this study have been accepted for presentation at the International Association for the Study of Lung Cancer meeting in Seoul, South Korea, September 1-5, 2007.
Based on the data from this ongoing trial, Exelixis recently notified GlaxoSmithKline (GSK) of its determination that it had achieved proof-of-concept for XL647 under the collaboration agreement between GSK and Exelixis. Under this agreement, GSK has approximately 3 months to review the data and decide whether to exercise its option to select the compound for further development. If XL647 is selected, Exelixis would receive a substantial selection milestone and potentially would receive commercialization milestones, royalties on product sales and, under certain circumstances, an option to co-promote in North America. GSK is currently reviewing the XL647 first-line NSCLC data, and Exelixis anticipates a decision from GSK early in the third quarter of 2007. Based on the data to date, Exelixis believes that XL647 strongly merits development either as part of its collaboration with GSK, independently or in collaboration with another company.
About XL647
XL647 is a potent inhibitor of EGFR, HER2, and VEGFR2, receptor tyrosine kinases (RTKs) that are implicated in driving tumor growth and vascularization (blood vessel formation). The compound has been optimized for high potency and oral bioavailability, demonstrates excellent activity in target-specific cellular functional assays, and has shown sustained inhibition of target RTKs in vivo following a single oral dose. Data from a Phase I trial of XL647 in patients with advanced solid tumors were presented most recently at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in November 2006.
About Exelixis
Exelixis, Inc. is a development-stage biotechnology company dedicated to the discovery and development of novel small molecule therapeutics for the treatment of cancer and other serious diseases. The company is leveraging its fully integrated drug discovery platform to fuel the growth of its development pipeline, which is primarily focused on cancer. Currently, Exelixis’ broad product pipeline includes investigational compounds in Phase II and Phase I clinical development for cancer and renal disease. Exelixis has established strategic corporate alliances with major pharmaceutical and biotechnology companies, including GlaxoSmithKline, Bristol-Myers Squibb Company, Genentech, Wyeth Pharmaceuticals and Sankyo. For more information, please visit the company’s web site at http://www.exelixis.com.
This press release contains forward-looking statements, including without limitation statements related to the potential efficacy of XL647. Words such as “suggest,” “believes,” “may,” " anticipates” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis’ current expectations. Forward-looking statements involve risks and uncertainties. Exelixis’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the potential failure of XL647 to demonstrate safety and efficacy in clinical testing. These and other risk factors are discussed under “Risk Factors” and elsewhere in Exelixis’ quarterly report on Form 10-Q for the fiscal quarter ended March 30, 2007 and other filings with the Securities and Exchange Commission. Exelixis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Exelixis, Inc.
CONTACT: Investor contact, Charles Butler, Director of CorporateCommunications, +1-650-837-7277, cbutler@exelixis.com, or media contact,Soleil Maxwell Harrison, Senior Manager of Corporate Communications,+1-650-837-7012, sharrison@exelixis.com, both of Exelixis, Inc.
Web site: http://www.exelixis.com/
