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ILX-651 Study in Prostate Cancer Initiated

SAN ANTONIO--(BUSINESS WIRE)--June 17, 2004--ILEX(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 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 melanoma and non-small cell lung cancer.

"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 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 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 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 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 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.

Source: Ilex Oncology

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