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Xcytrin Plus Taxotere for Advanced Recurrent Tumors at ASCO

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Xcytrin Plus Taxotere for Advanced Recurrent Tumors at ASCO 2005

Pharmacyclics, Inc. (Nasdaq: PCYC - News) today announced the publication of interim data from a Phase 1 dose escalation study of Xcytrin® (motexafin gadolinium) Injection, the company's lead anti-cancer agent, in combination with Taxotere® (docetaxel) for the treatment of patients with advanced refractory tumors. The published abstract is part of the proceedings at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting being held May 13-17, 2005, at the Orange County Convention Center in Orlando, FL.

The ongoing study has enrolled 13 patients of which 12 are evaluable for response at this time, including patients with metastatic cancer of the lung (9), ovary (2), prostate (1), and breast (1). Six patients receiving Xcytrin and Taxotere have achieved a partial response including four of the nine patients suffering from non-small cell lung cancer (NSCLC), the breast cancer patient, who was previously treated with taxol, and the prostate cancer patient. Two additional NSCLC patients achieved stabilization of their tumors. All of the patients in this study had failed one to five prior treatment regimens, which in three of the responding patients (two with NSCLC) included treatment with a member of the taxane family. Among the NSCLC patients whose tumors responded to the study treatment, the duration of response lasted for a median of 15 weeks (range 6-18 weeks).

"Our data demonstrate objective tumor responses in patients who have failed multiple previous therapies including treatment with taxanes," said Kishan Pandya, M.D., professor of medicine and oncology, James P. Wilmot Cancer Center at the University of Rochester, and principal investigator of the trial. "Xcytrin's novel mechanism of action and non-overlapping toxicity with chemotherapy make it a potentially appealing new agent for cancer therapy."

The Phase 1 dose-escalating study is designed to evaluate the safety and tumor response rate for the combination of Xcytrin with Taxotere. Successive cohorts of patients are given increasing doses of Xcytrin together with a standard dose of Taxotere and treatment is repeated every 21 days. No significant toxicity, other than that normally attributable to Taxotere, has been observed.

"These early results show promise for combining Xcytrin with chemotherapy drugs, such as Taxotere," said Richard A. Miller, M.D., president and chief executive officer of Pharmacyclics. "The activity in NSCLC is consistent with activity demonstrated in other trials involving patients with lung cancer. We will be pursuing additional trials with Xcytrin in NSCLC as a single agent and in combination with chemotherapy."

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