Miss Kim,
For your reading pleasure, I have pasted this article about XL880 from the corporate website
www.exelixis.com. As a bonus, I have provided a direct link to the clinical trial:
http://clinicaltrials.gov/ct/show/NCT00 ... AD?order=6
Enjoy!
Holly
Exelixis Initiates Phase II Clinical Development Program for XL880
- First Inhibitor of MET to Advance to Phase II Clinical Trials -
SOUTH SAN FRANCISCO, Calif., June 28, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of a Phase II program for XL880, an orally bioavailable small molecule inhibitor of the receptor tyrosine kinases (RTKs) involved in tumor cell growth, migration and angiogenesis including MET and VEGFR. The multi-center open-label Phase II study will be conducted in up to 15 clinical sites and is designed to enroll up to 34 patients with hereditary or sporadic papillary renal cell carcinoma. Primary objectives of the study are to determine best-confirmed response rate and to evaluate safety and tolerability of XL880 administered orally for five consecutive days every two weeks. Secondary objectives are to assess progression-free survival, overall survival, duration of response and to continue characterizing the pharmacokinetic and pharmacodynamics profiles of XL880. Subsequent Phase II trials will be carried out in head and neck and gastric cancer.
"We designed XL880 to have a very unique and exciting RTK inhibition profile and we have seen promising indications of its clinical and biologic activity in the Phase I trial," said George A. Scangos, president and chief executive officer of Exelixis. "There was significant interest in the Phase I trial data presented at ASCO, particularly around the two partial responses seen in the two patients with papillary renal cell carcinoma. XL880 was the first MET inhibitor to enter clinical development and is now the first to advance to Phase II clinical trials and we are very optimistic about the potential for XL880 to demonstrate benefit in this patient group."
As reported by Investigators in June 2006 at the American Society of Clinical Oncology (ASCO) annual meeting, XL880 has exhibited favorable safety and tolerability profiles in a Phase I trial in patients with advanced solid tumors. Of 19 patients evaluable for tumor responses in the Phase I trial, the two patients with papillary renal cell carcinoma had partial responses and seven other patients with a variety of tumors had stable disease for 3-13 months. Additionally, analysis of biopsy samples taken from a patient with melanoma who showed tumor reduction indicated that XL880 inhibited the activation of MET, RON, ERK and AKT and decreased proliferation and increased apoptosis in the tumor sample. These changes were not observed in samples of normal tissue taken from the same patient.
About XL880
XL880 is an orally available small molecule compound designed to target multiple RTKs implicated in the development, progression and spread of cancer. The primary targets of XL880 are the hepatocyte growth factor receptor (MET) and vascular endothelial growth factor RTK families, although platelet-derived growth factor receptor (PDGFR), RON, c-KIT, FLT3 and Tie-2 are also inhibited. Activation or overexpression of MET has been documented as a negative prognostic indicator in patients with various carcinomas, and in patients with multiple myeloma, glioma and other solid tumors. Activation of MET by mutation is the causative factor in an inherited kidney cancer syndrome, hereditary papillary renal cell carcinoma. Mutational or constitutive activation of MET has also been found in sporadic kidney cancer, lung carcinomas and head and neck carcinomas. MET is a key driver of tumor cell growth, motility, invasion, metastasis and angiogenesis. XL880 is the first orally bioavailable small molecule MET inhibitor to enter the clinic.
About Exelixis
Exelixis, Inc. is a biotechnology company dedicated to the discovery and development of novel therapeutics that will potentially enhance the care and lives of patients with cancer and other serious diseases. The company is leveraging its fully integrated gene-to-drug platform to fuel the growth of its proprietary drug pipeline. Exelixis' development pipeline covers cancer and metabolism and is comprised of the following compounds: XL119 (becatecarin), for which a multinational Phase III clinical trial in bile duct tumor is ongoing and which has been exclusively licensed to Helsinn Healthcare S.A.; XL784, which is being advanced in a Phase II trial as a treatment for renal disease; XL999, an anticancer compound currently in a Phase II program for a variety of solid tumors and hematologic malignancies; XL880, an anticancer compound currently in a Phase II program for a variety of solid tumors; XL647, XL820, XL844 and XL184, anticancer compounds currently in Phase I clinical trials; and multiple compounds in preclinical development for diseases including cancer and various metabolic and cardiovascular disorders. Exelixis has established broad corporate alliances with major pharmaceutical and biotechnology companies including GlaxoSmithKline (GSK) and Bristol-Myers Squibb Company. Pursuant to a product development and commercialization agreement between Exelixis and GSK, GSK has the option, after completion of clinical proof-of-concept by Exelixis, to elect to develop up to three compounds in Exelixis' product pipeline, which may include XL784 and the cancer compounds identified in this press release (other than XL119), thus potentially triggering milestone payments and royalties from GSK and co- promotion rights by Exelixis. For more information, please visit the company's web site at
www.exelixis.com.
This press release contains forward-looking statements, including without limitation statements related to the initiation of subsequent Phase II trials for XL880. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "slated," "goal" 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 product candidates to demonstrate safety and efficacy in clinical testing; the ability of Helsinn Healthcare S.A. to conduct the Phase III clinical trial of XL119 sufficient to achieve FDA approval; the ability to complete and initiate trials at the referenced times; the ability to conduct clinical trials sufficient to achieve a positive completion; the ability to file INDs at the referenced times; the ability of Exelixis to advance additional preclinical compounds into clinical development; the uncertainty of the FDA approval process; and the therapeutic and commercial value of the company's compounds. These and other risk factors are discussed under "Risk Factors" and elsewhere in our quarterly report on Form 10-Q for the quarter ended March 31, 2006 and other filings with the Securities and Exchange Commission. The company 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.
SOURCE Exelixis, Inc.
investors, Charles Butler Director, Corporate Communications, +1-650-837-7277, or
cbutler@exelixis.com, or press, Soleil Maxwell Harrison, Manager, Corporate Communications, +1-650-837-7012, or
sharrison@exelixis.com, both of Exelixis, Inc.