ILEX Initiates ILX-651 Study in Prostate Cancer; Third Phase II Trial in Solid Tumors Now Underway.SAN ANTONIO -- ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. (tm) Oncology, Inc. (Nasdaq:ILXO) announced today the opening of a multi-center Phase II study of ILX-651 in patients with hormone-refractory prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. whose disease has progressed after first-line treatment with Taxotere(R) (docetaxel). ILX-651 is a novel tubulin-interactive agent that has shown preliminary activity in a range of solid tumors. Two additional Phase II studies with ILX-651 are ongoing in metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. melanoma and non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. . "There are currently no standard treatments for patients with prostate cancer who have relapsed or who have not responded to docetaxel," said Terry Murdock, Sr. Vice President, Clinical Operations, ILEX Oncology. "Preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. suggest that ILX-651 has a unique mechanism of action, which warrants investigating this agent with this kind of resistant tumor." This non-randomized, open label study will enroll approximately 40 patients at 10 to 12 clinical research sites. Patients will be treated intravenously with ILX-651 daily for 5 consecutive days every 21 days. The trial is designed for patients to receive treatment with ILX-651 for up to one year. Results of a Phase I study recently presented by clinical investigators at the 2004 American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. annual meeting showed that ILX-651 appears to be biologically active and well-tolerated in patients with advanced refractory solid tumors. Preliminary safety data from the Phase II metastatic melanoma trial were also presented at ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company and showed that ILX-651 appears to be safe, tolerable and convenient for patients as administered in that trial. About ILX-651 ILX-651 is a next-generation synthetic pentapeptide pen·ta·pep·tide n. A polypeptide composed of five amino acids. analog of the natural substance dolastatin with a unique mechanism of action that potentially differs from that of microtubule-stabilizers (taxanes and epothilones) and tubulin tubulin /tu·bu·lin/ (too´bu-lin) the constituent protein of microtubules. tu·bu·lin n. A globular protein that is the structural constituent of microtubules. inhibitors (vinca alkaloids and other dolastatins). The drug has been chemically modified to provide improved pharmacological properties and is orally bioavailable with a potentially enhanced therapeutic window over earlier-generation dolastatins. ILX-651 has shown significant anti-tumor activity in preclinical models in a wide range of solid tumors, including cancer cells that are resistant to other tubulin-interactive drugs, such as the commonly prescribed taxanes. About ILEX Founded in 1994 as an oncology drug development company, ILEX has a marketed product, CAMPATH(R) in the United States and MABCAMPATH(R) in the European Union, and is advancing an innovative and diversified pipeline of compounds focused on the treatment of cancer. The ILEX pipeline comprises product candidates at various stages of clinical development, including monoclonal antibodies, novel cytotoxic agents, angiogenesis inhibitors and signal transduction inhibitors. Based in San Antonio, Texas “San Antonio” redirects here. For other uses, see San Antonio (disambiguation). San Antonio is the second most populous city in Texas, the third most populous metropolitan area in Texas, and is the seventh most populous city in the United States. As of the 2006 U.S. , ILEX maintains a core competency in oncology drug development. ILEX also conducts research in angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. inhibition, cell signaling, medicinal chemistry and nuclear receptor biology at its laboratories in Boston, Mass., and Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. , Switzerland. In February 2004, ILEX announced its agreement to merge with Genzyme Corporation, a global biotechnology company. The merger, subject to ILEX stockholder approval and other customary conditions, is expected to close in mid-2004. Further information about ILEX can be found on the company's Web site at www.ilexonc.com. Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because these statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Specifically, factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to: risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and in ILEX's compounds under development in particular; market acceptance of CAMPATH(R); the ability to expand the number and scope of the indications for which CAMPATH(R) is approved; the potential failure of ILEX's compounds under development to prove safe and effective for treatment of disease; uncertainties inherent in the early stage of ILEX's compounds under development; failure to successfully implement or complete clinical trials; failure to receive marketing clearance from regulatory agencies for our compounds under development; acquisitions, divestitures, mergers, licenses or strategic initiatives that change ILEX's business, structure or projections; the ability of ILEX to predict its future expenses and capital needs; the development of competing products; uncertainties related to ILEX's dependence on third parties and partners; and those risks described in ILEX's report on Form 10-K filed on March 12, 2004, and in other filings made by ILEX with the SEC. ILEX disclaims any obligation to update these forward-looking statements. |
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