ILEX Oncology Announces Phase III Skin Cancer Prevention Trial for DFMO.SAN ANTONIO--(BUSINESS WIRE)--Aug. 4, 1998--ILEX(tm) Oncology Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ILXO) today announced that a Phase III trial of its anticancer agent alpha-difluoromethylornithine (DFMO DFMO Difluoromethylornithine DFMO Doppler Filter Mixer-Oscillator DFMO Division Financial Management Office ) for the prevention of non-melanoma skin cancer Skin Cancer, Non-Melanoma Definition Non-melanoma skin cancer is a malignant growth of the external surface or epithelial layer of the skin. Description will begin enrolling patients this month. The study, led by Paul P. Carbone, M.D., professor of medicine and former director of the University of Wisconsin's Comprehensive Cancer Center, with grant support from the National Cancer Institute (NCI See Liberate. ), represents the first Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the of DFMO as a chemoprevention che·mo·pre·ven·tion n. The use of chemical agents, drugs, or food supplements to prevent disease. chemoprevention agent to inhibit the recurrence of cancer. The skin cancer prevention study will test DFMO versus placebo in a double blind, Phase III, controlled, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial of 340 subjects with a history of either basal cell basal cell n. A type of cell found in the deepest layer of the epithelium. or squamous cell cancer Squamous cell cancer A form of skin cancer that usually originates in sun-damaged areas or pre-existing lesions; at first local and superficial, it may later spread to other areas of the body. Mentioned in: Cryotherapy . The drug will be administered orally in low doses, with patients remaining on the trial for an average of four years. The trial will assess DFMO's efficacy to inhibit the recurrence of cancer. "In previous studies, DFMO has shown a broad range of activity as a preventative agent for a variety of cancers in animals," said Dr. Carbone. "This Phase III trial provides the oncology community an opportunity to evaluate DFMO's ability to interfere with the underlying process of cancer development and progression, in hopes of treating the cause rather than the effect." DFMO is a selective irreversible inhibitor of an enzyme that controls formation of certain polyamines required by dividing cells such as cancer cells. More than 900,000 new cases of basal cell or squamous cell cancers are diagnosed each year in the United States, most commonly in individuals with lightly pigmented skin. While these kinds of cancers are highly treatable, individuals with a history of basal or squamous cell cancer have a 50 percent chance on average of developing new skin cancers within five years. "Despite the advances being made in the screening and diagnosis of pre-malignant conditions, the medical community lacks preventative therapies to close the treatment gap," said Richard Love, president and chief executive officer of ILEX Ilex a bush bearing berries containing saponins; cause vomiting, diarrhea. Called also holly. . "We are, therefore, extremely encouraged by the NCI's continued support and sponsorship to develop DFMO as a prevention agent." ILEX and the NCI are currently conducting Phase II trials at other sites to assess DFMO's efficacy as a chemoprevention agent in recurrent colon polyps and Barrett's esophagus, recognized precursors for colon or esophageal cancer. ILEX is also conducting Phase II trials of DFMO in anal and cervical intraepithelial dysplasias, precursors of anal and cervical cancer, respectively. ILEX Oncology Inc. is a drug development company focused exclusively on the development and marketing approval of drugs for the treatment and prevention of cancer. ILEX provides pharmaceutical and biotechnology companies compounds for their pipeline through its Products subsidiary, as well as drug development and manufacturing services on a contract basis via a Services subsidiary. ILEX's close association with cancer research and treatment institutions allows access to both the opinion leaders and patients necessary for the development of oncology drugs. 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 such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward looking statements. 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, competitive risks and those risks and uncertainties discussed in filings made by ILEX Oncology Inc. with the Securities and Exchange Commission. This release and other information about ILEX(tm) Oncology can be found on the World Wide Web at http://www.ilexoncology.com.
CONTACT: ILEX Oncology Inc., San Antonio
Beth Shapiro, 210/949-8223 (Public Relations)
or
Ann Stevens, 210/949-8230 (Investor Relations)
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