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Patient Enrollment Begins for Phase 2 Trial of Motexafin Gadolinium

SUNNYVALE, Calif., July 8 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (NASDAQ:PCYC) today announced that it is enrolling patients in a Phase 2 clinical trial of Xcytrin(R) (motexafin gadolinium) Injection, the company's lead cancer therapeutic candidate, for the treatment of patients with metastatic renal cell carcinoma. The trial is being conducted at the Baylor College of Medicine in Houston, Texas.

The trial will evaluate the efficacy and safety of Xcytrin used as a single agent in approximately 40 patients with metastatic renal cell carcinoma. In patients with metastatic renal cell carcinoma, the cancer has spread beyond the kidney to other sites in the body. Eligible patients may receive Xcytrin as their initial therapy or following relapse from other therapies. Xcytrin will be given intravenously daily for five days every two weeks until disease progression.

"We are very interested in evaluating Xcytrin as a single agent for the treatment of metastatic renal cell carcinoma. Its tumor selectivity and novel mechanism make it an attractive potential agent for treatment of this deadly disease," said Dr. Robert Amato, associate professor and director of the Genitourinary Oncology Clinic in the Scott Department of Urology at Baylor College of Medicine in Houston, and principal investigator of the clinical trial. "Renal cell cancer has particular mutations that may make it susceptible to the effects of Xcytrin. Current therapies for renal cell cancer are inadequate and new agents with novel mechanisms are needed."

Xcytrin, an anti-cancer agent with a unique mechanism of action, selectively concentrates in tumors and induces apoptosis (programmed cell death) of tumor cells. Preclinical studies indicate that Xcytrin inhibits growth of tumor cells, is cytotoxic to tumor cells, and also enhances the cytotoxic activity of selected chemotherapeutics and targeted biologic agents.

"Xcytrin is now in clinical trials for a wide range of cancers. We are systematically evaluating its potential in various oncology indications including its use as a single agent, and in combination with radiation or chemotherapy," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics.

Currently, Xcytrin is being investigated in a randomized Phase 3 clinical trial designed to compare the effects of whole brain radiation therapy (WBRT) alone to that of WBRT plus Xcytrin for the treatment of brain metastases (cancer that has spread to the brain from another part of the body) in patients suffering from non-small cell lung cancer (NSCLC).

About Renal Cell Carcinoma
Approximately 31,000 patients are diagnosed with renal cell carcinoma each year in the U.S. Approximately 12,000 will die from the disease every year. The cancer metastasizes readily, most often to the lungs and other organs, and about one-third of patients have metastasis at the time of diagnosis. There is no cure for metastatic renal cell cancer, which is generally unresponsive to standard chemotherapy agents.

About Xcytrin
Pharmacyclics has been granted Fast-Track status by the U.S. Food and Drug Administration (FDA) for Xcytrin for the treatment of brain metastases in NSCLC patients. Also, Xcytrin is being evaluated in several Phase 1 and Phase 2 clinical trials to measure its efficacy and safety as a single agent and in combination with chemotherapy and/or radiation therapy for various cancers.

Source: Pharmacyclics, Inc.

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