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Biotech / Medical : Pharmacyclics (PCYC) -- Ignore unavailable to you. Want to Upgrade?

To: tnsaf who wrote (686)	4/15/2002 10:42:30 PM
From: mopgcw	Read Replies (1) \| Respond to of 717

Pharmacyclics Plans Addil Phase 3 Clinical Trial With Xcytrin DOW JONES NEWSWIRES SUNNYVALE, Calif. -- Pharmacyclics Inc. (PCYC) will conduct an additional Phase III clinical trial of its lead product Xcytrin Injection after holding discussions with the Food and Drug Administration. Xcytrin is a drug that prevents cancer cells from repairing damage caused by the effects of radiation and chemotherapy without increasing damage to normal tissue. In a press release Monday, the pharmaceutical company said the additional trial will try to confirm data from its initial Phase III trial that showed Xcytrin helped patients with lung cancer. A Pharmacyclics spokesman wasn't immediately available for comment. An FDA spokesman declined to comment. In December, based on an initial examination of results, the pharmaceutical company said that although the Phase III Xcytrin Injection trial didn't achieve statistical significance on the primary endpoints, the effect in those with lung cancer supports the drug's activity and suggested Xcytrin may increase local control of radiation therapy. Pharmacyclics President and Chief Executive Richard A. Miller said in a statement that discussions with the FDA "confirmed that time to neurologic progress and neurocognitive function are important measurements of clinical benefit." Shares of Pharmacyclics closed Monday at $7.27, up 2 cents, or 0.3%, on Nasdaq volume of 44,100 shares. Average daily volume is 253,756 shares. In after-hours trading, the shares fell 41 cents, or 6%, to $6.86, according to the Island ECN. -Stephen Lee; Dow Jones Newswires; 201-938-5400 A Pharmacyclics spokesman said the FDA needed more data beyond the company's initial trial of Xcytrin. Based on discussions with the FDA, the company decided to conduct the additional trial. Pharmacyclics anticipates filing a new drug application for Xcytrin in two to three years, the spokesman said.